Overview

This trial is active, not recruiting.

Condition spinal cord injury
Treatment stem cell transplantation
Phase phase 1/phase 2
Sponsor Stem Cells Arabia
Start date January 2016
End date June 2021
Trial size 50 participants
Trial identifier NCT02687672, SCA-SCI1

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Injection of leukapheresis-derived, purified, autologous CD34+and CD133+ stem cells
stem cell transplantation
Transplantation of autologous stem cells
(Experimental)
Injection of bone marrow-derived, purified, autologous CD34+and CD133+ stem cells.
stem cell transplantation
Transplantation of autologous stem cells

Primary Outcomes

Measure
Overall clinical improvement in sensory and motor functions using ASIA (American Spinal Cord Injury Association)
time frame: 60 months

Secondary Outcomes

Measure
Improvement in urine and stool incontinence using a questionnaire
time frame: 6 months
Functional improvement in impotence and previous sexual erection status (male patients) using a questionnaire
time frame: 6 months
Improvement in quality of life using a questionnaire
time frame: 6 months
Improvement in personal independence and productivity using questionnaire
time frame: 6 months

Eligibility Criteria

Male or female participants from 5 years up to 50 years old.

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.

Additional Information

Official title 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.
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Stem Cells Arabia.