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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2021-12-31

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.

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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.

Conditions

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Spinal Cord Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Stem Cell Transplantation

Injection of leukapheresis-derived, purified, autologous CD34+and CD133+ stem cells

Group Type EXPERIMENTAL

Stem Cell Transplantation

Intervention Type BIOLOGICAL

Transplantation of autologous stem cells

Stem Cells

Injection of bone marrow-derived, purified, autologous CD34+and CD133+ stem cells.

Group Type EXPERIMENTAL

Stem Cell Transplantation

Intervention Type BIOLOGICAL

Transplantation of autologous stem cells

Interventions

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Stem Cell Transplantation

Transplantation of autologous stem cells

Intervention Type BIOLOGICAL

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.

Minimum Eligible Age

5 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No