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| Name | Class |
|---|---|
| The Emmes Company, LLC | INDUSTRY |
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The purpose of this study is to look at the safety of treatment with stem cells in patients with Frailty.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pilot phase - Group 1 | Experimental | Group 1 participants will receive Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 20 million allo-hMSCs/kg delivered via peripheral intravenous infusion. Participants in this group have the option to receive an additional 3 infusions of 100million allo-hMSCs/kg per infusion with a 12 to 18 month interval. |
|
| Pilot Phase - Group 2 | Experimental | Group 2 - Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 100 million allo-hMSCs/kg delivered via peripheral intravenous infusion. Participants in this group have the option to receive an additional 3 infusions of 100million allo-hMSCs/kg per infusion with a 12 to 18 month interval. |
|
| Pilot Phase - Group 3 | Experimental | Group 3 - Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 200 million allo-hMSCs/kg delivered via peripheral intravenous infusion. Participants in this group have the option to receive an additional 3 infusions of 100million allo-hMSCs/kg per infusion with a 12 to 18 month interval. |
|
| Randomized Phase - Group A | Experimental | Group A - Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 100 million allo-hMSCs/kg delivered via peripheral intravenous infusion. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) | Biological | Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Any Treatment Emergent - Serious Adverse Events (TE-SAEs) | Incidence of any treatment-emergent serious adverse events (SAE), defined as the composite of: death, non-fatal pulmonary embolism, stroke, hospitalization for worsening dyspnea and clinically significant laboratory test abnormalities.
| One Month post infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Frailty as Assessed by CHAMPS Questionnaire | Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire measures duration of exercise-related activities (hours/week). The Duration variable can range from 0 - 399.75 hours per week. Higher scores indicate more activity. | At baseline and 6 month follow-up visit. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joshua M Hare, MD | ISCI / University of Miami Miller School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ISCI/University of Miami Miller School of Medicine | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26933813 | Background | Golpanian S, DiFede DL, Pujol MV, Lowery MH, Levis-Dusseau S, Goldstein BJ, Schulman IH, Longsomboon B, Wolf A, Khan A, Heldman AW, Goldschmidt-Clermont PJ, Hare JM. Rationale and design of the allogeneiC human mesenchymal stem cells (hMSC) in patients with aging fRAilTy via intravenoUS delivery (CRATUS) study: A phase I/II, randomized, blinded and placebo controlled trial to evaluate the safety and potential efficacy of allogeneic human mesenchymal stem cell infusion in patients with aging frailty. Oncotarget. 2016 Mar 15;7(11):11899-912. doi: 10.18632/oncotarget.7727. | |
| 28977399 |
| Label | URL |
|---|---|
| Interdisciplinary Stem Cell Institute at the University of Miami Miller School of Medicine | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pilot Phase - Group 1 | Group 1 participants will receive Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 20 million allo-hMSCs/kg delivered via peripheral intravenous infusion. Participants in this group have the option to receive an additional 3 infusions of 100million allo-hMSCs/kg per infusion with a 12 to 18 month interval. Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Infusion 1 |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 19, 2021 |
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| Randomized phase - Group B | Experimental | Group B - Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 200 million allo-hMSCs/kg delivered via peripheral intravenous infusion. |
|
| Randomized Phase - Group C | Experimental | Group C - Placebo delivered via peripheral intravenous infusion. Participants in this group have the option to receive one additional infusion of 100million allo-hMSCs/kg with a 12 to 18 month interval. |
|
| Addendum B - Antibiotic free cell Group | Experimental | Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 100 million penicillin/streptomycin-free allo-hMSCs/kg delivered via peripheral intravenous infusion. Participants in this group have the option to receive an additional 3 infusions of 100million allo-hMSCs/kg per infusion with a 12 to 18 month interval. |
|
| Placebo | Biological | Placebo administered by peripheral intravenous infusion. |
|
| Penicillin/Streptomycin-Free Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) | Biological | Penicillin/Streptomycin-Free Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion. |
|
| Change in Slowing of Mobility as Measured by 4 Meter Gait Speed Test |
4-meter gait speed test measures the time (in seconds) taken to walk a distance of 4 meters. The total score has a range of 1 point - 4 points with the higher score indicating faster walk speed. |
| At baseline and 6 month follow-up visit. |
| Change in Slowing of Mobility as Measured by SPPB | Standard Physical Performance Battery (SPPB) Assessment has total score ranging from 0-4 with the higher score indicating better balance. | At baseline and 6 month follow-up visit. |
| Change in Weight | Change in weight as measured in kilograms (kg). | At baseline and 6 month follow-up visit. |
| Change in Diminished Hand Grip Strength | Hand grip strength as assessed by a dynamometer. Grip strength is recorded (in mmHg) three times for each hand. The average reading is reported for each hand. | At baseline and 6 month follow-up visit. |
| Change in Exhaustion as Measured by the MFI Questionnaire | Multi-dimensional Fatigue Inventory (MFI) Questionnaire contains 20 questions with a 5-point scale. The MFI has total score ranging from 20-100 with the higher score indicating less fatigue. | At baseline and 6 month follow-up visit. |
| Change in Quality of Life (QoL) as Measured by the ICECAP Questionnaire | Investigating Choice Experiences for the Preferences of Older People (ICEpop) Capability measure for Older people (ICECAP) questionnaire has total score ranging from 5-20 with the higher score indicating greater quality of life. | At baseline and 6 month follow-up visit. |
| Change in Quality of Life (QoL) as Measured by the SF-36 Questionnaire | Short Form (SF)-36 Questionnaire has consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. Lower scores indicate the more disability, and higher scores indicate less disability. | At baseline and 6 month follow-up visit. |
| Change in Quality of Life (QoL) as Measured by the EQ-5D-3L Questionnaire | EuroQoL (EQ)- 5 Dimension (5D)- 3 levels (3L) Questionnaire has total score ranging from 0-10 for the 5 dimensions. Higher scores indicate better Quality of Life. | At baseline and 6 month follow-up visit. |
| Change in Quality of Life (QoL) as Measured by the EQ-5D-3L Overall Health Status Scale. | EuroQoL - 5 Dimension - 3 levels (EQ-5D-3L) Overall health status question has a range of 0-100. Higher scores indicate better Quality of Life. | At baseline and 6 month follow-up visit. |
| Change in Sense of Smell as Measured by UPSIT | University of Pennsylvania Smell Identification Test (UPSIT) smell test booklet has a total score ranging from 0-40 with higher scores indicating better olfaction. | At baseline and 6 month follow-up visit. |
| Death | Any reported death from any cause. | Up to 12 months. |
| Change in Ejection Fraction (EF) | Change in dobutamine stress echocardiogram induced ejection fraction | At baseline and 6 month follow-up visit. |
| Change in Inflammatory Markers Levels | Change in inflammatory markers including C-Reactive Protein (CRP) and Fibrinogen serum samples as measured in mg/L. | At baseline and 6 month follow-up visit. |
| Change in Inflammatory Markers | Change in inflammatory markers including Interleukin (IL)-6 and Tumor Necrosis Factor (TNF) Alpha from serum samples as measured in pg/mL. | At baseline and 6 month follow-up visit. |
| Change in Inflammatory Marker D-dimer Levels | Change in inflammatory marker D-Dimer from serum samples as measured in mg/dL. | At baseline and 6 month follow-up visit. |
| Background |
| Tompkins BA, DiFede DL, Khan A, Landin AM, Schulman IH, Pujol MV, Heldman AW, Miki R, Goldschmidt-Clermont PJ, Goldstein BJ, Mushtaq M, Levis-Dusseau S, Byrnes JJ, Lowery M, Natsumeda M, Delgado C, Saltzman R, Vidro-Casiano M, Da Fonseca M, Golpanian S, Premer C, Medina A, Valasaki K, Florea V, Anderson E, El-Khorazaty J, Mendizabal A, Green G, Oliva AA, Hare JM. Allogeneic Mesenchymal Stem Cells Ameliorate Aging Frailty: A Phase II Randomized, Double-Blind, Placebo-Controlled Clinical Trial. J Gerontol A Biol Sci Med Sci. 2017 Oct 12;72(11):1513-1522. doi: 10.1093/gerona/glx137. |
| 28444181 | Background | Golpanian S, DiFede DL, Khan A, Schulman IH, Landin AM, Tompkins BA, Heldman AW, Miki R, Goldstein BJ, Mushtaq M, Levis-Dusseau S, Byrnes JJ, Lowery M, Natsumeda M, Delgado C, Saltzman R, Vidro-Casiano M, Pujol MV, Da Fonseca M, Oliva AA Jr, Green G, Premer C, Medina A, Valasaki K, Florea V, Anderson E, El-Khorazaty J, Mendizabal A, Goldschmidt-Clermont PJ, Hare JM. Allogeneic Human Mesenchymal Stem Cell Infusions for Aging Frailty. J Gerontol A Biol Sci Med Sci. 2017 Oct 12;72(11):1505-1512. doi: 10.1093/gerona/glx056. |
| FG001 | Pilot Phase - Group 2 | Group 2 - Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 100 million allo-hMSCs/kg delivered via peripheral intravenous infusion. Participants in this group have the option to receive an additional 3 infusions of 100million allo-hMSCs/kg per infusion with a 12 to 18 month interval. Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion |
| FG002 | Pilot Phase - Group 3 | Group 3 - Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 200 million allo-hMSCs/kg delivered via peripheral intravenous infusion. Participants in this group have the option to receive an additional 3 infusions of 100million allo-hMSCs/kg per infusion with a 12 to 18 month interval. Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion |
| FG003 | Randomized Phase - Group A | Group A - Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 100 million allo-hMSCs/kg delivered via peripheral intravenous infusion. Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion |
| FG004 | Randomized Phase - Group B | Group B - Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 200 million allo-hMSCs/kg delivered via peripheral intravenous infusion. Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion |
| FG005 | Randomized Phase - Group C | Group C - Placebo delivered via peripheral intravenous infusion. Participants in this group have the option to receive one additional infusion of 100million allo-hMSCs/kg with a 12 to 18 month interval. Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion Placebo: Placebo administered by peripheral intravenous infusion. |
| FG006 | Addendum B - Antibiotic Free Cell Group | Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 100 million penicillin/streptomycin-free allo-hMSCs/kg delivered via peripheral intravenous infusion. Participants in this group have the option to receive an additional 3 infusions of 100million allo-hMSCs/kg per infusion with a 12 to 18 month interval. Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion Penicillin/Streptomycin-Free Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Penicillin/Streptomycin-Free Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Infusion 2 |
|
|
| Infusion 3 |
|
|
| Infusion 4 |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pilot Phase - Group 1 | Group 1 participants will receive Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 20 million allo-hMSCs/kg delivered via peripheral intravenous infusion. Participants in this group have the option to receive an additional 3 infusions of 100million allo-hMSCs/kg per infusion with a 12 to 18 month interval. Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion |
| BG001 | Pilot Phase - Group 2 | Group 2 - Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 100 million allo-hMSCs/kg delivered via peripheral intravenous infusion. Participants in this group have the option to receive an additional 3 infusions of 100million allo-hMSCs/kg per infusion with a 12 to 18 month interval. Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion |
| BG002 | Pilot Phase - Group 3 | Group 3 - Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 200 million allo-hMSCs/kg delivered via peripheral intravenous infusion. Participants in this group have the option to receive an additional 3 infusions of 100million allo-hMSCs/kg per infusion with a 12 to 18 month interval. Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion |
| BG003 | Randomized Phase - Group A | Group A - Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 100 million allo-hMSCs/kg delivered via peripheral intravenous infusion. Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion |
| BG004 | Randomized Phase - Group B | Group B - Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 200 million allo-hMSCs/kg delivered via peripheral intravenous infusion. Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion |
| BG005 | Randomized Phase - Group C | Group C - Placebo delivered via peripheral intravenous infusion. Participants in this group have the option to receive one additional infusion of 100million allo-hMSCs/kg with a 12 to 18 month interval. Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion Placebo: Placebo administered by peripheral intravenous infusion. |
| BG006 | Addendum B - Antibiotic Free Cell Group | Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 100 million penicillin/streptomycin-free allo-hMSCs/kg delivered via peripheral intravenous infusion. Participants in this group have the option to receive an additional 3 infusions of 100million allo-hMSCs/kg per infusion with a 12 to 18 month interval. Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion Penicillin/Streptomycin-Free Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Penicillin/Streptomycin-Free Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion. |
| BG007 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Any Treatment Emergent - Serious Adverse Events (TE-SAEs) | Incidence of any treatment-emergent serious adverse events (SAE), defined as the composite of: death, non-fatal pulmonary embolism, stroke, hospitalization for worsening dyspnea and clinically significant laboratory test abnormalities.
| Participants were allowed to opt-in to receive additional infusion based on cohort | Posted | Number | Incidents | One Month post infusion |
|
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Frailty as Assessed by CHAMPS Questionnaire | Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire measures duration of exercise-related activities (hours/week). The Duration variable can range from 0 - 399.75 hours per week. Higher scores indicate more activity. | Not Posted | At baseline and 6 month follow-up visit. | Participants | ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Slowing of Mobility as Measured by 4 Meter Gait Speed Test | 4-meter gait speed test measures the time (in seconds) taken to walk a distance of 4 meters. The total score has a range of 1 point - 4 points with the higher score indicating faster walk speed. | Not Posted | At baseline and 6 month follow-up visit. | Participants | ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Slowing of Mobility as Measured by SPPB | Standard Physical Performance Battery (SPPB) Assessment has total score ranging from 0-4 with the higher score indicating better balance. | Not Posted | At baseline and 6 month follow-up visit. | Participants | ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Weight | Change in weight as measured in kilograms (kg). | Not Posted | At baseline and 6 month follow-up visit. | Participants | ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Diminished Hand Grip Strength | Hand grip strength as assessed by a dynamometer. Grip strength is recorded (in mmHg) three times for each hand. The average reading is reported for each hand. | Not Posted | At baseline and 6 month follow-up visit. | Participants | ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Exhaustion as Measured by the MFI Questionnaire | Multi-dimensional Fatigue Inventory (MFI) Questionnaire contains 20 questions with a 5-point scale. The MFI has total score ranging from 20-100 with the higher score indicating less fatigue. | Not Posted | At baseline and 6 month follow-up visit. | Participants | ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Quality of Life (QoL) as Measured by the ICECAP Questionnaire | Investigating Choice Experiences for the Preferences of Older People (ICEpop) Capability measure for Older people (ICECAP) questionnaire has total score ranging from 5-20 with the higher score indicating greater quality of life. | Not Posted | At baseline and 6 month follow-up visit. | Participants | ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Quality of Life (QoL) as Measured by the SF-36 Questionnaire | Short Form (SF)-36 Questionnaire has consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. Lower scores indicate the more disability, and higher scores indicate less disability. | Not Posted | At baseline and 6 month follow-up visit. | Participants | ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Quality of Life (QoL) as Measured by the EQ-5D-3L Questionnaire | EuroQoL (EQ)- 5 Dimension (5D)- 3 levels (3L) Questionnaire has total score ranging from 0-10 for the 5 dimensions. Higher scores indicate better Quality of Life. | Not Posted | At baseline and 6 month follow-up visit. | Participants | ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Quality of Life (QoL) as Measured by the EQ-5D-3L Overall Health Status Scale. | EuroQoL - 5 Dimension - 3 levels (EQ-5D-3L) Overall health status question has a range of 0-100. Higher scores indicate better Quality of Life. | Not Posted | At baseline and 6 month follow-up visit. | Participants | ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Sense of Smell as Measured by UPSIT | University of Pennsylvania Smell Identification Test (UPSIT) smell test booklet has a total score ranging from 0-40 with higher scores indicating better olfaction. | Not Posted | At baseline and 6 month follow-up visit. | Participants | ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Death | Any reported death from any cause. | Not Posted | Up to 12 months. | Participants | ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Ejection Fraction (EF) | Change in dobutamine stress echocardiogram induced ejection fraction | Not Posted | At baseline and 6 month follow-up visit. | Participants | ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Inflammatory Markers Levels | Change in inflammatory markers including C-Reactive Protein (CRP) and Fibrinogen serum samples as measured in mg/L. | Not Posted | At baseline and 6 month follow-up visit. | Participants | ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Inflammatory Markers | Change in inflammatory markers including Interleukin (IL)-6 and Tumor Necrosis Factor (TNF) Alpha from serum samples as measured in pg/mL. | Not Posted | At baseline and 6 month follow-up visit. | Participants | ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Inflammatory Marker D-dimer Levels | Change in inflammatory marker D-Dimer from serum samples as measured in mg/dL. | Not Posted | At baseline and 6 month follow-up visit. | Participants |
Up to 6 years
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pilot Phase - Group 1 | Group 1 participants will receive Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 20 million allo-hMSCs/kg delivered via peripheral intravenous infusion. Participants in this group have the option to receive an additional 3 infusions of 100million allo-hMSCs/kg per infusion with a 12 to 18 month interval. Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion | 0 | 5 | 0 | 5 | 0 | 5 |
| EG001 | Pilot Phase - Group 2 | Group 2 - Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 100 million allo-hMSCs/kg delivered via peripheral intravenous infusion. Participants in this group have the option to receive an additional 3 infusions of 100million allo-hMSCs/kg per infusion with a 12 to 18 month interval. Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion | 0 | 5 | 1 | 5 | 0 | 5 |
| EG002 | Pilot Phase - Group 3 | Group 3 - Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 200 million allo-hMSCs/kg delivered via peripheral intravenous infusion. Participants in this group have the option to receive an additional 3 infusions of 100million allo-hMSCs/kg per infusion with a 12 to 18 month interval. Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion | 1 | 5 | 1 | 5 | 0 | 5 |
| EG003 | Randomized Phase - Group A | Group A - Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 100 million allo-hMSCs/kg delivered via peripheral intravenous infusion. Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion | 0 | 10 | 0 | 10 | 0 | 10 |
| EG004 | Randomized Phase - Group B | Group B - Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 200 million allo-hMSCs/kg delivered via peripheral intravenous infusion. Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion | 1 | 10 | 2 | 10 | 0 | 10 |
| EG005 | Randomized Phase - Group C | Group C - Placebo delivered via peripheral intravenous infusion. Participants in this group have the option to receive one additional infusion of 100million allo-hMSCs/kg with a 12 to 18 month interval. Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion Placebo: Placebo administered by peripheral intravenous infusion. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG006 | Addendum B - Antibiotic Free Cell Group | Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 100 million penicillin/streptomycin-free allo-hMSCs/kg delivered via peripheral intravenous infusion. Participants in this group have the option to receive an additional 3 infusions of 100million allo-hMSCs/kg per infusion with a 12 to 18 month interval. Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion Penicillin/Streptomycin-Free Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): Penicillin/Streptomycin-Free Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion. | 1 | 20 | 1 | 20 | 0 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stroke | Vascular disorders | Systematic Assessment |
| ||
| Upper Respiratory Infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Congestive Heart Failure | Cardiac disorders | Systematic Assessment |
| ||
| Leukocytosis | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Microscopic Hematuria | Renal and urinary disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joshua M Hare, MD | University of Miami, Miller School of Medicine - Interdisciplinary Stem Cell Institute (ISCI) | 305-243-5579 | JHare@med.miami.edu |
| Mar 25, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D010406 | Penicillins |
| ID | Term |
|---|---|
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| Infusion #2 |
|
|
| Infusion #3 |
|
|
| infusion #4 |
|
|