Transplantation of Autologous Bone Marrow or Leukapheresis-Derived Stem Cells for Treatment of Spinal Cord Injury

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Transplantation of Purified Autologous Bone Marrow- or Leukapheresis-Derived CD34+ and CD133+ for Patients With Spinal Cord Injuries: A Long-Term Comparative Evaluation of Safety and Efficacy Study.

Conditions
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Spinal Cord Injury

Intervention / Treatment
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* Biological: Stem Cell Transplantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients suffering from chronic spinal cord injury Age of injury ranging from 6-60 months prior to enrollment in this study. Ability and willingness to regularly visit Jordan Orthopedic and Spinal Center for post operation follow up. Traumatic Injury of spinal cord with complete or partial damage confirmed by MRI. Exclusion Criteria: Injuries less than 6 months old or more than 60 months old Non-traumatic injuries (SCI due to inflammation, autoimmune diseases) Patients less than 5 or older than 50 years Patients suffering from other conditions, including chronic neurological diseases, diabetes mellitus, cardiac/kidney/liver disorders, previous strokes, and previous surgeries unrelated to spinal cord injury.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stem Cell Transplantation<br>Injection of leukapheresis-derived, purified, autologous CD34+and CD133+ stem cells | Biological: Stem Cell Transplantation<br>* Transplantation of autologous stem cells<br>|
| Experimental: Stem Cells<br>Injection of bone marrow-derived, purified, autologous CD34+and CD133+ stem cells. | Biological: Stem Cell Transplantation<br>* Transplantation of autologous stem cells<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall clinical improvement in sensory and motor functions using ASIA (American Spinal Cord Injury Association) |  | 60 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Improvement in quality of life using a questionnaire |  | 6 months | 
| Improvement in personal independence and productivity using questionnaire |  | 6 months |