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This is a double-armed, Phase I/II trial aims to compare bone marrow and leukapheresis as sources for purified, autologous CD34+ and CD133+ stem cells (SCs), to be utilized in treatment of patients with chronic complete spinal cord injuries (SCI). The study focuses on the safety and efficacy of transplanting un-manipulated, autologous, purified stem cells into the injured spinal cords of patients.
Spinal cord injury (SCI) leads to apoptosis of oligodendrocytes at the injury site resulting in demyelination and neuronal degeneration. This degeneration causes severe functional sensory and motor mutilations that remain an immense challenge to physicians and in which stem cell (SC) transplantation represents a viable alternative. This study is a phase I/II trial aimed at describing a method for treating patients with chronic complete spinal cord injuries (SCI) by utilizing autologous, purified CD34+ and CD133+ stem cells (SCs). The study focuses on the safety and efficacy of transplanting un-manipulated, autologous, purified stem cells in treated patients during a 5-year follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stem Cell Transplantation | Experimental | Injection of leukapheresis-derived, purified, autologous CD34+and CD133+ stem cells |
|
| Stem Cells | Experimental | Injection of bone marrow-derived, purified, autologous CD34+and CD133+ stem cells. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stem Cell Transplantation | Biological | Transplantation of autologous stem cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall clinical improvement in sensory and motor functions using ASIA (American Spinal Cord Injury Association) | 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in urine and stool incontinence using a questionnaire | 6 months | |
| Functional improvement in impotence and previous sexual erection status (male patients) using a questionnaire | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adeeb AlZoubi, PhD | Contact | 00962795337575 | adeebalzoubi@stemcellsarabia.net |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stem Cells Arabia | Recruiting | Amman | 11953 | Jordan |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D033581 | Stem Cell Transplantation |
| ID | Term |
|---|---|
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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| Improvement in quality of life using a questionnaire | 6 months |
| Improvement in personal independence and productivity using questionnaire | 6 months |
| D014947 | Wounds and Injuries |
| D014180 |
| Transplantation |
| D013514 | Surgical Procedures, Operative |