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

March 15, 2020 updated by: Stem Cells Arabia

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stem Cells Arabia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

February 16, 2016

First Submitted That Met QC Criteria

February 16, 2016

First Posted (Estimate)

February 22, 2016

Study Record Updates

Last Update Posted (Actual)

March 17, 2020

Last Update Submitted That Met QC Criteria

March 15, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCA-SCI1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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