| Primary | Safety as Assessed by Number of Participants With In-hospital Infusion Toxicity | In-hospital infusion toxicity includes hemodynamic, pulmonary, hepatic, renal, or neurologic complications. | | Posted | | Count of Participants | | Participants | | 24 hours after infusion | | | | ID | Title | Description |
|---|
| OG000 | Umbilical Cord Blood (UCB) Cells | umbilical cord blood (hUCB) cells: Autologous umbilical cord blood banked with the Cord Blood Registry. | | OG001 | Bone Marrow-derived Mononuclear Cells (BMMNCs) | bone marrow derived mononuclear cells (BMMNCs): Autologous stem cells from bone marrow harvest. | | OG002 | Saline Infusion (Placebo) | saline infusion (placebo): inactive substance |
| | | Title | Denominators | Categories |
|---|
| | |
| |
| Primary | Long-term Safety | Long-term safety as assessed by number of participants who developed new mass lesions or other pathological structural changes or had worsening neurological status | Two in the BMMNC arm were lost to follow up. | Posted | | Count of Participants | | Participants | | from the time of infusion to 1 year after infusion | | | | ID | Title | Description |
|---|
| OG000 | Umbilical Cord Blood (UCB) Cells | umbilical cord blood (hUCB) cells: Autologous umbilical cord blood banked with the Cord Blood Registry. | | OG001 | Bone Marrow-derived Mononuclear Cells (BMMNCs) | bone marrow derived mononuclear cells (BMMNCs): Autologous stem cells from bone marrow harvest. | | OG002 | Saline Infusion (Placebo) | saline infusion (placebo): inactive substance |
| |
| Secondary | Number of Participants With an Improvement in White Matter Integrity. | Number of participants with an improvement in white matter integrity as measured by diffusion tensor imaging (DTI) magnetic resonance imaging (MRI) reconstruction of corticospinal tract (CST) radial diffusivity (RD). Improvement is defined as radial diffusivity (RD) decreased in at least one corticospinal tract (CST) reconstruction. | Two in the BMMNC arm were lost to follow up. | Posted | | Count of Participants | | Participants | | from baseline to 1 year after infusion | | | | ID | Title | Description |
|---|
| OG000 | Umbilical Cord Blood (UCB) Cells | umbilical cord blood (hUCB) cells: Autologous umbilical cord blood banked with the Cord Blood Registry. | | OG001 | Bone Marrow-derived Mononuclear Cells (BMMNCs) | bone marrow derived mononuclear cells (BMMNCs): Autologous stem cells from bone marrow harvest. | | OG002 | Saline Infusion (Placebo) | saline infusion (placebo): inactive substance |
| |
| Secondary | Gross Motor Function Classification Score (GMFM-66) | Interval age adjusted scaled scores from 0 to 100 with 0 reflecting a child with low motor ability and 100 indicating high motor ability. | | Posted | | Mean | Standard Deviation | score on a scale | | baseline before infusion | | | | ID | Title | Description |
|---|
| OG000 | Umbilical Cord Blood (UCB) Cells | umbilical cord blood (hUCB) cells: Autologous umbilical cord blood banked with the Cord Blood Registry. | | OG001 | Bone Marrow-derived Mononuclear Cells (BMMNCs) | bone marrow derived mononuclear cells (BMMNCs): Autologous stem cells from bone marrow harvest. | | OG002 | Saline Infusion (Placebo) | saline infusion (placebo): inactive substance |
| |
| Secondary | Gross Motor Function Classification Score (GMFM-66) | Interval age adjusted scaled scores from 0 to 100 with 0 reflecting a child with low motor ability and 100 indicating high motor ability. | Two in the BMMNC arm were lost to follow up. | Posted | | Mean | Standard Deviation | score on a scale | | 1 year after infusion | | | | ID | Title | Description |
|---|
| OG000 | Umbilical Cord Blood (UCB) Cells | umbilical cord blood (hUCB) cells: Autologous umbilical cord blood banked with the Cord Blood Registry. | | OG001 | Bone Marrow-derived Mononuclear Cells (BMMNCs) | bone marrow derived mononuclear cells (BMMNCs): Autologous stem cells from bone marrow harvest. | | OG002 | Saline Infusion (Placebo) | saline infusion (placebo): inactive substance |
| |
| Secondary | Gross Motor Function Classification Score (GMFM-88) | Ordinal age adjusted scaled raw and percent scores from 0 to 100 with 0 reflecting a child with low motor ability and 100 indicating high motor ability. | | Posted | | Mean | Standard Deviation | score on a scale | | baseline before infusion | | | | ID | Title | Description |
|---|
| OG000 | Umbilical Cord Blood (UCB) Cells | umbilical cord blood (hUCB) cells: Autologous umbilical cord blood banked with the Cord Blood Registry. | | OG001 | Bone Marrow-derived Mononuclear Cells (BMMNCs) | bone marrow derived mononuclear cells (BMMNCs): Autologous stem cells from bone marrow harvest. | | OG002 | Saline Infusion (Placebo) | saline infusion (placebo): inactive substance |
| |
| Secondary | Gross Motor Function Classification Score (GMFM-88) | Ordinal age adjusted scaled raw and percent scores from 0 to 100 with 0 reflecting a child with low motor ability and 100 indicating high motor ability. | Two in the BMMNC arm were lost to follow up. | Posted | | Mean | Standard Deviation | score on a scale | | 1 year after infusion | | | | ID | Title | Description |
|---|
| OG000 | Umbilical Cord Blood (UCB) Cells | umbilical cord blood (hUCB) cells: Autologous umbilical cord blood banked with the Cord Blood Registry. | | OG001 | Bone Marrow-derived Mononuclear Cells (BMMNCs) | bone marrow derived mononuclear cells (BMMNCs): Autologous stem cells from bone marrow harvest. | | OG002 | Saline Infusion (Placebo) | saline infusion (placebo): inactive substance |
| |
| Secondary | Score on Vineland Adaptive Behavior Scales (VABS-2) - Communication | Standard score ranging from 20 to 140 with higher scores indicate a child with a higher level of functioning and lower scores indicate a lower level of functioning. | | Posted | | Mean | Standard Deviation | score on a scale | | baseline before infusion | | | | ID | Title | Description |
|---|
| OG000 | Umbilical Cord Blood (UCB) Cells | umbilical cord blood (hUCB) cells: Autologous umbilical cord blood banked with the Cord Blood Registry. | | OG001 | Bone Marrow-derived Mononuclear Cells (BMMNCs) | bone marrow derived mononuclear cells (BMMNCs): Autologous stem cells from bone marrow harvest. | | OG002 | Saline Infusion (Placebo) | saline infusion (placebo): inactive substance |
| |
| Secondary | Score on Vineland Adaptive Behavior Scales (VABS-2) - Communication | Standard score ranging from 20 to 140 with higher scores indicate a child with a higher level of functioning and lower scores indicate a lower level of functioning. | Two in the BMMNC arm were lost to follow up. | Posted | | Mean | Standard Deviation | score on a scale | | 1 year after infusion | | | | ID | Title | Description |
|---|
| OG000 | Umbilical Cord Blood (UCB) Cells | umbilical cord blood (hUCB) cells: Autologous umbilical cord blood banked with the Cord Blood Registry. | | OG001 | Bone Marrow-derived Mononuclear Cells (BMMNCs) | bone marrow derived mononuclear cells (BMMNCs): Autologous stem cells from bone marrow harvest. | | OG002 | Saline Infusion (Placebo) | saline infusion (placebo): inactive substance |
| |
| Secondary | Score on Vineland Adaptive Behavior Scales (VABS-2) - Daily Living | Standard score ranging from 20 to 140 with higher scores indicate a child with a higher level of functioning and lower scores indicate a lower level of functioning. | | Posted | | Mean | Standard Deviation | score on a scale | | baseline before infusion | | | | ID | Title | Description |
|---|
| OG000 | Umbilical Cord Blood (UCB) Cells | umbilical cord blood (hUCB) cells: Autologous umbilical cord blood banked with the Cord Blood Registry. | | OG001 | Bone Marrow-derived Mononuclear Cells (BMMNCs) | bone marrow derived mononuclear cells (BMMNCs): Autologous stem cells from bone marrow harvest. | | OG002 | Saline Infusion (Placebo) | saline infusion (placebo): inactive substance |
| |
| Secondary | Score on Vineland Adaptive Behavior Scales (VABS-2) - Daily Living | Standard score ranging from 20 to 140 with higher scores indicate a child with a higher level of functioning and lower scores indicate a lower level of functioning. | Two in the BMMNC arm were lost to follow up. | Posted | | Mean | Standard Deviation | score on a scale | | 1 year after infusion | | | | ID | Title | Description |
|---|
| OG000 | Umbilical Cord Blood (UCB) Cells | umbilical cord blood (hUCB) cells: Autologous umbilical cord blood banked with the Cord Blood Registry. | | OG001 | Bone Marrow-derived Mononuclear Cells (BMMNCs) | bone marrow derived mononuclear cells (BMMNCs): Autologous stem cells from bone marrow harvest. | | OG002 | Saline Infusion (Placebo) | saline infusion (placebo): inactive substance |
| |
| Secondary | Score on Vineland Adaptive Behavior Scales (VABS-2) - Social | Standard score ranging from 20 to 140 with higher scores indicate a child with a higher level of functioning and lower scores indicate a lower level of functioning. | | Posted | | Mean | Standard Deviation | score on a scale | | baseline before infusion | | | | ID | Title | Description |
|---|
| OG000 | Umbilical Cord Blood (UCB) Cells | umbilical cord blood (hUCB) cells: Autologous umbilical cord blood banked with the Cord Blood Registry. | | OG001 | Bone Marrow-derived Mononuclear Cells (BMMNCs) | bone marrow derived mononuclear cells (BMMNCs): Autologous stem cells from bone marrow harvest. | | OG002 | Saline Infusion (Placebo) | saline infusion (placebo): inactive substance |
| |
| Secondary | Score on Vineland Adaptive Behavior Scales (VABS-2) - Social | Standard score ranging from 20 to 140 with higher scores indicate a child with a higher level of functioning and lower scores indicate a lower level of functioning. | Two in the BMMNC arm were lost to follow up. One BMMNC subject was untestable at this time point. | Posted | | Mean | Standard Deviation | score on a scale | | 1 year after infusion | | | | ID | Title | Description |
|---|
| OG000 | Umbilical Cord Blood (UCB) Cells | umbilical cord blood (hUCB) cells: Autologous umbilical cord blood banked with the Cord Blood Registry. | | OG001 | Bone Marrow-derived Mononuclear Cells (BMMNCs) | bone marrow derived mononuclear cells (BMMNCs): Autologous stem cells from bone marrow harvest. | | OG002 | Saline Infusion (Placebo) | saline infusion (placebo): inactive substance |
| |
| Secondary | Score on Vineland Adaptive Behavior Scales (VABS-2) - Motor | Standard score ranging from 20 to 140 with higher scores indicate a child with a higher level of functioning and lower scores indicate a lower level of functioning. | 9 subjects were untestable. | Posted | | Mean | Standard Deviation | score on a scale | | baseline before infusion | | | | ID | Title | Description |
|---|
| OG000 | Umbilical Cord Blood (UCB) Cells | umbilical cord blood (hUCB) cells: Autologous umbilical cord blood banked with the Cord Blood Registry. | | OG001 | Bone Marrow-derived Mononuclear Cells (BMMNCs) | bone marrow derived mononuclear cells (BMMNCs): Autologous stem cells from bone marrow harvest. | | OG002 | Saline Infusion (Placebo) | saline infusion (placebo): inactive substance |
| |
| Secondary | Score on Vineland Adaptive Behavior Scales (VABS-2) - Motor | Standard score ranging from 20 to 140 with higher scores indicate a child with a higher level of functioning and lower scores indicate a lower level of functioning. | Two in the BMMNC arm were lost to follow up. Nine subjects were untestable at this time point. | Posted | | Mean | Standard Deviation | score on a scale | | 1 year after infusion | | | | ID | Title | Description |
|---|
| OG000 | Umbilical Cord Blood (UCB) Cells | umbilical cord blood (hUCB) cells: Autologous umbilical cord blood banked with the Cord Blood Registry. | | OG001 | Bone Marrow-derived Mononuclear Cells (BMMNCs) | bone marrow derived mononuclear cells (BMMNCs): Autologous stem cells from bone marrow harvest. | | OG002 | Saline Infusion (Placebo) | saline infusion (placebo): inactive substance |
| |
| Secondary | Score on Pediatric Evaluation of Disability Inventory - Self-Care | Standard scores ranging from 0 to 100 with higher scores indicate a child with a higher level of functioning and lower scores indicate a lower level of functioning. | | Posted | | Mean | Standard Deviation | score on a scale | | baseline before infusion | | | | ID | Title | Description |
|---|
| OG000 | Umbilical Cord Blood (UCB) Cells | umbilical cord blood (hUCB) cells: Autologous umbilical cord blood banked with the Cord Blood Registry. | | OG001 | Bone Marrow-derived Mononuclear Cells (BMMNCs) | bone marrow derived mononuclear cells (BMMNCs): Autologous stem cells from bone marrow harvest. | | OG002 | Saline Infusion (Placebo) | saline infusion (placebo): inactive substance |
| |
| Secondary | Score on Pediatric Evaluation of Disability Inventory - Self-Care | Standard scores ranging from 0 to 100 with higher scores indicate a child with a higher level of functioning and lower scores indicate a lower level of functioning. | Two in the BMMNC arm were lost to follow up. | Posted | | Mean | Standard Deviation | score on a scale | | 1 year after infusion | | | | ID | Title | Description |
|---|
| OG000 | Umbilical Cord Blood (UCB) Cells | umbilical cord blood (hUCB) cells: Autologous umbilical cord blood banked with the Cord Blood Registry. | | OG001 | Bone Marrow-derived Mononuclear Cells (BMMNCs) | bone marrow derived mononuclear cells (BMMNCs): Autologous stem cells from bone marrow harvest. | | OG002 | Saline Infusion (Placebo) | saline infusion (placebo): inactive substance |
| |
| Secondary | Score on Pediatric Evaluation of Disability Inventory - Mobility | Standard scores ranging from 0 to 100 with higher scores indicate a child with a higher level of functioning and lower scores indicate a lower level of functioning. | | Posted | | Mean | Standard Deviation | score on a scale | | baseline before infusion | | | | ID | Title | Description |
|---|
| OG000 | Umbilical Cord Blood (UCB) Cells | umbilical cord blood (hUCB) cells: Autologous umbilical cord blood banked with the Cord Blood Registry. | | OG001 | Bone Marrow-derived Mononuclear Cells (BMMNCs) | bone marrow derived mononuclear cells (BMMNCs): Autologous stem cells from bone marrow harvest. | | OG002 | Saline Infusion (Placebo) | saline infusion (placebo): inactive substance |
| |
| Secondary | Score on Pediatric Evaluation of Disability Inventory - Mobility | Standard scores ranging from 0 to 100 with higher scores indicate a child with a higher level of functioning and lower scores indicate a lower level of functioning. | Two in the BMMNC arm were lost to follow up. | Posted | | Mean | Standard Deviation | score on a scale | | 1 year after infusion | | | | ID | Title | Description |
|---|
| OG000 | Umbilical Cord Blood (UCB) Cells | umbilical cord blood (hUCB) cells: Autologous umbilical cord blood banked with the Cord Blood Registry. | | OG001 | Bone Marrow-derived Mononuclear Cells (BMMNCs) | bone marrow derived mononuclear cells (BMMNCs): Autologous stem cells from bone marrow harvest. | | OG002 | Saline Infusion (Placebo) | saline infusion (placebo): inactive substance |
| |
| Secondary | Score on Pediatric Evaluation of Disability Inventory - Social | Standard scores ranging from 0 to 100 with higher scores indicate a child with a higher level of functioning and lower scores indicate a lower level of functioning. | | Posted | | Mean | Standard Deviation | score on a scale | | baseline before infusion | | | | ID | Title | Description |
|---|
| OG000 | Umbilical Cord Blood (UCB) Cells | umbilical cord blood (hUCB) cells: Autologous umbilical cord blood banked with the Cord Blood Registry. | | OG001 | Bone Marrow-derived Mononuclear Cells (BMMNCs) | bone marrow derived mononuclear cells (BMMNCs): Autologous stem cells from bone marrow harvest. | | OG002 | Saline Infusion (Placebo) | saline infusion (placebo): inactive substance |
| |
| Secondary | Score on Pediatric Evaluation of Disability Inventory - Social | Standard scores ranging from 0 to 100 with higher scores indicate a child with a higher level of functioning and lower scores indicate a lower level of functioning. | Two in the BMMNC arm were lost to follow up. | Posted | | Mean | Standard Deviation | score on a scale | | 1 year after infusion | | | | ID | Title | Description |
|---|
| OG000 | Umbilical Cord Blood (UCB) Cells | umbilical cord blood (hUCB) cells: Autologous umbilical cord blood banked with the Cord Blood Registry. | | OG001 | Bone Marrow-derived Mononuclear Cells (BMMNCs) | bone marrow derived mononuclear cells (BMMNCs): Autologous stem cells from bone marrow harvest. | | OG002 | Saline Infusion (Placebo) | saline infusion (placebo): inactive substance |
| |
| Secondary | Score on A Developmental NEuroPSYchological Assessment (NEPSY-II) - Learning and Memory Memory Subtest - Recall | Scales scores from 1 to 19 with higher scores indicate better outcomes and lower scores indicate poorer outcomes. | Data were not collected for the 5 in the UCB cell arm and 4 in the placebo arm. Untestable with this instrument. | Posted | | Mean | Standard Deviation | score on a scale | | baseline before infusion | | | | ID | Title | Description |
|---|
| OG000 | Umbilical Cord Blood (UCB) Cells | umbilical cord blood (hUCB) cells: Autologous umbilical cord blood banked with the Cord Blood Registry. | | OG001 | Bone Marrow-derived Mononuclear Cells (BMMNCs) | bone marrow derived mononuclear cells (BMMNCs): Autologous stem cells from bone marrow harvest. | | OG002 | Saline Infusion (Placebo) | saline infusion (placebo): inactive substance |
| |
| Secondary | Score on A Developmental NEuroPSYchological Assessment (NEPSY-II) - Learning and Memory Memory Subtest - Recall | Scales scores from 1 to 19 with higher scores indicate better outcomes and lower scores indicate poorer outcomes. | Only 4 subjects were testable at this time point. | Posted | | Mean | Standard Deviation | score on a scale | | 1 year after infusion | | | | ID | Title | Description |
|---|
| OG000 | Umbilical Cord Blood (UCB) Cells | umbilical cord blood (hUCB) cells: Autologous umbilical cord blood banked with the Cord Blood Registry. | | OG001 | Bone Marrow-derived Mononuclear Cells (BMMNCs) | bone marrow derived mononuclear cells (BMMNCs): Autologous stem cells from bone marrow harvest. | | OG002 | Saline Infusion (Placebo) | saline infusion (placebo): inactive substance |
| |
| Secondary | Score on A Developmental NEuroPSYchological Assessment (NEPSY-II) - Learning and Memory Memory Subtest - Free/Cued | Scales scores from 1 to 19 with higher scores indicate better outcomes and lower scores indicate poorer outcomes. | Only 4 subjects were testable at this time point. | Posted | | Mean | Standard Deviation | score on a scale | | baseline before infusion | | | | ID | Title | Description |
|---|
| OG000 | Umbilical Cord Blood (UCB) Cells | umbilical cord blood (hUCB) cells: Autologous umbilical cord blood banked with the Cord Blood Registry. | | OG001 | Bone Marrow-derived Mononuclear Cells (BMMNCs) | bone marrow derived mononuclear cells (BMMNCs): Autologous stem cells from bone marrow harvest. | | OG002 | Saline Infusion (Placebo) | saline infusion (placebo): inactive substance |
| |
| Secondary | Score on A Developmental NEuroPSYchological Assessment (NEPSY-II) - Learning and Memory Memory Subtest - Free/Cued | Scales scores from 1 to 19 with higher scores indicate better outcomes and lower scores indicate poorer outcomes. | Only 3 subjects were testable at this time point. | Posted | | Mean | Standard Deviation | score on a scale | | 1 year after infusion | | | | ID | Title | Description |
|---|
| OG000 | Umbilical Cord Blood (UCB) Cells | umbilical cord blood (hUCB) cells: Autologous umbilical cord blood banked with the Cord Blood Registry. | | OG001 | Bone Marrow-derived Mononuclear Cells (BMMNCs) | bone marrow derived mononuclear cells (BMMNCs): Autologous stem cells from bone marrow harvest. | | OG002 | Saline Infusion (Placebo) | saline infusion (placebo): inactive substance |
| |
| Secondary | Expressive and Receptive Vocabulary as Assessed by Score on the Peabody Picture Vocabulary Test (PPVT-4) | Standard score ranging from 20 to 160. Higher scores indicate a child with a higher level of functioning and lower scores indicate a lower level of functioning. | Only 7 subjects were testable with this instrument. | Posted | | Mean | Standard Deviation | score on a scale | | baseline before infusion | | | | ID | Title | Description |
|---|
| OG000 | Umbilical Cord Blood (UCB) Cells | umbilical cord blood (hUCB) cells: Autologous umbilical cord blood banked with the Cord Blood Registry. | | OG001 | Bone Marrow-derived Mononuclear Cells (BMMNCs) | bone marrow derived mononuclear cells (BMMNCs): Autologous stem cells from bone marrow harvest. | | OG002 | Saline Infusion (Placebo) | saline infusion (placebo): inactive substance |
| |
| Secondary | Expressive and Receptive Vocabulary as Assessed by Score on the Peabody Picture Vocabulary Test (PPVT-4) | Standard score ranging from 20 to 160. Higher scores indicate a child with a higher level of functioning and lower scores indicate a lower level of functioning. | Only 6 subjects were testable at this time point. | Posted | | Mean | Standard Deviation | score on a scale | | 1 year after infusion | | | | ID | Title | Description |
|---|
| OG000 | Umbilical Cord Blood (UCB) Cells | umbilical cord blood (hUCB) cells: Autologous umbilical cord blood banked with the Cord Blood Registry. | | OG001 | Bone Marrow-derived Mononuclear Cells (BMMNCs) | bone marrow derived mononuclear cells (BMMNCs): Autologous stem cells from bone marrow harvest. | | OG002 | Saline Infusion (Placebo) | saline infusion (placebo): inactive substance |
| |
| Secondary | Score on Cerebral Palsy Quality of Life Questionnaire (CPQOL) - Family | Standard scores ranging from 0 to 100 with higher scores indicate a child with a higher level of functioning and lower scores indicate a lower level of functioning. | Only 7 subjects were testable with this instrument. | Posted | | Mean | Standard Deviation | score on a scale | | baseline before infusion | | | | ID | Title | Description |
|---|
| OG000 | Umbilical Cord Blood (UCB) Cells | umbilical cord blood (hUCB) cells: Autologous umbilical cord blood banked with the Cord Blood Registry. | | OG001 | Bone Marrow-derived Mononuclear Cells (BMMNCs) | bone marrow derived mononuclear cells (BMMNCs): Autologous stem cells from bone marrow harvest. | | OG002 | Saline Infusion (Placebo) | saline infusion (placebo): inactive substance |
| |
| Secondary | Score on Cerebral Palsy Quality of Life Questionnaire (CPQOL) - Family | Standard scores ranging from 0 to 100 with higher scores indicate a child with a higher level of functioning and lower scores indicate a lower level of functioning. | Two in the BMMNC arm were lost to follow up. | Posted | | Mean | Standard Deviation | score on a scale | | 1 year after infusion | | | | ID | Title | Description |
|---|
| OG000 | Umbilical Cord Blood (UCB) Cells | umbilical cord blood (hUCB) cells: Autologous umbilical cord blood banked with the Cord Blood Registry. | | OG001 | Bone Marrow-derived Mononuclear Cells (BMMNCs) | bone marrow derived mononuclear cells (BMMNCs): Autologous stem cells from bone marrow harvest. | | OG002 | Saline Infusion (Placebo) | saline infusion (placebo): inactive substance |
| |
| Secondary | Score on Cerebral Palsy Quality of Life Questionnaire (CPQOL) - Social | Standard scores ranging from 0 to 100 with higher scores indicate a child with a higher level of functioning and lower scores indicate a lower level of functioning. | Only 8 subjects were testable with this instrument | Posted | | Mean | Standard Deviation | score on a scale | | baseline before infusion | | | | ID | Title | Description |
|---|
| OG000 | Umbilical Cord Blood (UCB) Cells | umbilical cord blood (hUCB) cells: Autologous umbilical cord blood banked with the Cord Blood Registry. | | OG001 | Bone Marrow-derived Mononuclear Cells (BMMNCs) | bone marrow derived mononuclear cells (BMMNCs): Autologous stem cells from bone marrow harvest. | | OG002 | Saline Infusion (Placebo) | saline infusion (placebo): inactive substance |
| |
| Secondary | Score on Cerebral Palsy Quality of Life Questionnaire (CPQOL) - Social | Standard scores ranging from 0 to 100 with higher scores indicate a child with a higher level of functioning and lower scores indicate a lower level of functioning. | Two in the BMMNC arm were lost to follow up. Five subjects were untestable. | Posted | | Mean | Standard Deviation | score on a scale | | 1 year after infusion | | | | ID | Title | Description |
|---|
| OG000 | Umbilical Cord Blood (UCB) Cells | umbilical cord blood (hUCB) cells: Autologous umbilical cord blood banked with the Cord Blood Registry. | | OG001 | Bone Marrow-derived Mononuclear Cells (BMMNCs) | bone marrow derived mononuclear cells (BMMNCs): Autologous stem cells from bone marrow harvest. | | OG002 | Saline Infusion (Placebo) | saline infusion (placebo): inactive substance |
| |
| Secondary | Score on Cerebral Palsy Quality of Life Questionnaire (CPQOL) - Feelings | Standard scores ranging from 0 to 100 with higher scores indicate a child with a higher level of functioning and lower scores indicate a lower level of functioning. | 13 subjects were testable with this instrument. | Posted | | Mean | Standard Deviation | score on a scale | | baseline before infusion | | | | ID | Title | Description |
|---|
| OG000 | Umbilical Cord Blood (UCB) Cells | umbilical cord blood (hUCB) cells: Autologous umbilical cord blood banked with the Cord Blood Registry. | | OG001 | Bone Marrow-derived Mononuclear Cells (BMMNCs) | bone marrow derived mononuclear cells (BMMNCs): Autologous stem cells from bone marrow harvest. | | OG002 | Saline Infusion (Placebo) | saline infusion (placebo): inactive substance |
| |
| Secondary | Score on Cerebral Palsy Quality of Life Questionnaire (CPQOL) - Feelings | Standard scores ranging from 0 to 100 with higher scores indicate a child with a higher level of functioning and lower scores indicate a lower level of functioning. | Two in the BMMNC arm were lost to follow up. Five subjects were untestable. | Posted | | Mean | Standard Deviation | score on a scale | | 1 year after infusion | | | | ID | Title | Description |
|---|
| OG000 | Umbilical Cord Blood (UCB) Cells | umbilical cord blood (hUCB) cells: Autologous umbilical cord blood banked with the Cord Blood Registry. | | OG001 | Bone Marrow-derived Mononuclear Cells (BMMNCs) | bone marrow derived mononuclear cells (BMMNCs): Autologous stem cells from bone marrow harvest. | | OG002 | Saline Infusion (Placebo) | saline infusion (placebo): inactive substance |
| |
| Secondary | Score on Cerebral Palsy Quality of Life Questionnaire (CPQOL) - Participation | Standard scores ranging from 0 to 100 with higher scores indicate a child with a higher level of functioning and lower scores indicate a lower level of functioning. | Only 8 subjects were testable with this instrument. | Posted | | Mean | Standard Deviation | score on a scale | | baseline before infusion | | | | ID | Title | Description |
|---|
| OG000 | Umbilical Cord Blood (UCB) Cells | umbilical cord blood (hUCB) cells: Autologous umbilical cord blood banked with the Cord Blood Registry. | | OG001 | Bone Marrow-derived Mononuclear Cells (BMMNCs) | bone marrow derived mononuclear cells (BMMNCs): Autologous stem cells from bone marrow harvest. | | OG002 | Saline Infusion (Placebo) | saline infusion (placebo): inactive substance |
| |
| Secondary | Score on Cerebral Palsy Quality of Life Questionnaire (CPQOL) - Participation | Standard scores ranging from 0 to 100 with higher scores indicate a child with a higher level of functioning and lower scores indicate a lower level of functioning. | Two in the BMMNC arm were lost to follow up. Five subjects were untestable at this time point. | Posted | | Mean | Standard Deviation | score on a scale | | 1 year after infusion | | | | ID | Title | Description |
|---|
| OG000 | Umbilical Cord Blood (UCB) Cells | umbilical cord blood (hUCB) cells: Autologous umbilical cord blood banked with the Cord Blood Registry. | | OG001 | Bone Marrow-derived Mononuclear Cells (BMMNCs) | bone marrow derived mononuclear cells (BMMNCs): Autologous stem cells from bone marrow harvest. | | OG002 | Saline Infusion (Placebo) | saline infusion (placebo): inactive substance |
| |
| Secondary | Score on Cerebral Palsy Quality of Life Questionnaire (CPQOL) - Emotional | Standard scores ranging from 0 to 100 with higher scores indicate a child with a higher level of functioning and lower scores indicate a lower level of functioning. | Only 8 subjects were testable with this instrument. | Posted | | Mean | Standard Deviation | score on a scale | | baseline before infusion | | | | ID | Title | Description |
|---|
| OG000 | Umbilical Cord Blood (UCB) Cells | umbilical cord blood (hUCB) cells: Autologous umbilical cord blood banked with the Cord Blood Registry. | | OG001 | Bone Marrow-derived Mononuclear Cells (BMMNCs) | bone marrow derived mononuclear cells (BMMNCs): Autologous stem cells from bone marrow harvest. | | OG002 | Saline Infusion (Placebo) | saline infusion (placebo): inactive substance |
| |
| Secondary | Score on Cerebral Palsy Quality of Life Questionnaire (CPQOL) - Emotional | Standard scores ranging from 0 to 100 with higher scores indicate a child with a higher level of functioning and lower scores indicate a lower level of functioning. | Two in the BMMNC arm were lost to follow up. Five other subjects were untestable at this time point. | Posted | | Mean | Standard Deviation | score on a scale | | 1 year after infusion | | | | ID | Title | Description |
|---|
| OG000 | Umbilical Cord Blood (UCB) Cells | umbilical cord blood (hUCB) cells: Autologous umbilical cord blood banked with the Cord Blood Registry. | | OG001 | Bone Marrow-derived Mononuclear Cells (BMMNCs) | bone marrow derived mononuclear cells (BMMNCs): Autologous stem cells from bone marrow harvest. | | OG002 | Saline Infusion (Placebo) | saline infusion (placebo): inactive substance |
| |
| Secondary | Score on Cerebral Palsy Quality of Life Questionnaire (CPQOL) - Access | Standard scores ranging from 0 to 100 with higher scores indicate a child with a higher level of functioning and lower scores indicate a lower level of functioning. | Only 8 subjects were testable with this instrument. | Posted | | Mean | Standard Deviation | score on a scale | | baseline before infusion | | | | ID | Title | Description |
|---|
| OG000 | Umbilical Cord Blood (UCB) Cells | umbilical cord blood (hUCB) cells: Autologous umbilical cord blood banked with the Cord Blood Registry. | | OG001 | Bone Marrow-derived Mononuclear Cells (BMMNCs) | bone marrow derived mononuclear cells (BMMNCs): Autologous stem cells from bone marrow harvest. | | OG002 | Saline Infusion (Placebo) | saline infusion (placebo): inactive substance |
| |
| Secondary | Score on Cerebral Palsy Quality of Life Questionnaire (CPQOL) - Access | Standard scores ranging from 0 to 100 with higher scores indicate a child with a higher level of functioning and lower scores indicate a lower level of functioning. | Two in the BMMNC arm were lost to follow up. Five subjects were untestable at this time point. | Posted | | Mean | Standard Deviation | score on a scale | | 1 year after infusion | | | | ID | Title | Description |
|---|
| OG000 | Umbilical Cord Blood (UCB) Cells | umbilical cord blood (hUCB) cells: Autologous umbilical cord blood banked with the Cord Blood Registry. | | OG001 | Bone Marrow-derived Mononuclear Cells (BMMNCs) | bone marrow derived mononuclear cells (BMMNCs): Autologous stem cells from bone marrow harvest. | | OG002 | Saline Infusion (Placebo) | saline infusion (placebo): inactive substance |
| |
| Secondary | Score on Cerebral Palsy Quality of Life Questionnaire (CPQOL) - Pain | Standard scores ranging from 0 to 100 with higher scores indicate a child with a higher level of functioning and lower scores indicate a lower level of functioning. | Only 7 subjects were testable with this instrument. | Posted | | Mean | Standard Deviation | score on a scale | | baseline before infusion | | | | ID | Title | Description |
|---|
| OG000 | Umbilical Cord Blood (UCB) Cells | umbilical cord blood (hUCB) cells: Autologous umbilical cord blood banked with the Cord Blood Registry. | | OG001 | Bone Marrow-derived Mononuclear Cells (BMMNCs) | bone marrow derived mononuclear cells (BMMNCs): Autologous stem cells from bone marrow harvest. | | OG002 | Saline Infusion (Placebo) | saline infusion (placebo): inactive substance |
| |
| Secondary | Score on Cerebral Palsy Quality of Life Questionnaire (CPQOL) - Pain | Standard scores ranging from 0 to 100 with higher scores indicate a child with a higher level of functioning and lower scores indicate a lower level of functioning. | Two in the BMMNC arm were lost to follow up. Eight subjects were untestable at this time point. | Posted | | Mean | Standard Deviation | score on a scale | | 1 year after infusion | | | | ID | Title | Description |
|---|
| OG000 | Umbilical Cord Blood (UCB) Cells | umbilical cord blood (hUCB) cells: Autologous umbilical cord blood banked with the Cord Blood Registry. | | OG001 | Bone Marrow-derived Mononuclear Cells (BMMNCs) | bone marrow derived mononuclear cells (BMMNCs): Autologous stem cells from bone marrow harvest. | | OG002 | Saline Infusion (Placebo) | saline infusion (placebo): inactive substance |
| |
| Secondary | Visual-Spatial Processing as Assessed by Score on the Motor-Free Visual Perception Test (MVPT-3) | Standard scores ranging from 55 to 145 with higher scores indicating better outcomes and lower scores poorer outcomes. | Only three subjects were testable with this instrument. | Posted | | Mean | Standard Deviation | score on a scale | | baseline before infusion | | | | ID | Title | Description |
|---|
| OG000 | Umbilical Cord Blood (UCB) Cells | umbilical cord blood (hUCB) cells: Autologous umbilical cord blood banked with the Cord Blood Registry. | | OG001 | Bone Marrow-derived Mononuclear Cells (BMMNCs) | bone marrow derived mononuclear cells (BMMNCs): Autologous stem cells from bone marrow harvest. | | OG002 | Saline Infusion (Placebo) | saline infusion (placebo): inactive substance |
| |
| Secondary | Visual-Spatial Processing as Assessed by Score on the Motor-Free Visual Perception Test (MVPT-3) | Standard scores ranging from 55 to 145 with higher scores indicating better outcomes and lower scores poorer outcomes. | Data were not collected for the 5 in the UCB cell arm. | Posted | | Mean | Standard Deviation | score on a scale | | 1 year after infusion | | | | ID | Title | Description |
|---|
| OG000 | Umbilical Cord Blood (UCB) Cells | umbilical cord blood (hUCB) cells: Autologous umbilical cord blood banked with the Cord Blood Registry. | | OG001 | Bone Marrow-derived Mononuclear Cells (BMMNCs) | bone marrow derived mononuclear cells (BMMNCs): Autologous stem cells from bone marrow harvest. | | OG002 | Saline Infusion (Placebo) | saline infusion (placebo): inactive substance |
| |