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

Phase 2

• Conditions: Spinal Cord Injury
• Interventions: Biological: Stem Cell Transplantation

• Registration Number: NCT02687672
• Lead Sponsor: Stem Cells Arabia

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-02-16
• Study First Submitted QC: 2016-02-16
• Study First Posted: 2016-02-22
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-15
• Last Update Posted: 2020-03-17
• Primary Completion: 2021-06
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stem Cell Transplantation	Stem Cell Transplantation	Injection of leukapheresis-derived, purified, autologous CD34+and CD133+ stem cells
Stem Cells	Stem Cell Transplantation	Injection of bone marrow-derived, purified, autologous CD34+and CD133+ stem cells.

Primary Outcome Measures

Name	Time	Method
Overall clinical improvement in sensory and motor functions using ASIA (American Spinal Cord Injury Association)	60 months

Secondary Outcome Measures

Name	Time	Method
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
Improvement in urine and stool incontinence using a questionnaire	6 months

Trial Locations

Locations (1)

Stem Cells Arabia; 🇯🇴 Amman, Jordan