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

Primary Purpose

Spinal Cord Injury

Status
Unknown status
Phase
Phase 2
Locations
Jordan
Study Type
Interventional
Intervention
Stem Cell Transplantation
Sponsored by
Stem Cells Arabia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury

Eligibility Criteria

5 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Stem Cells ArabiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Stem Cell Transplantation

Stem Cells

Arm Description

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

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

Outcomes

Primary Outcome Measures

Overall clinical improvement in sensory and motor functions using ASIA (American Spinal Cord Injury Association)

Secondary Outcome Measures

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

Full Information

First Posted
February 16, 2016
Last Updated
March 15, 2020
Sponsor
Stem Cells Arabia
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1. Study Identification

Unique Protocol Identification Number
NCT02687672
Brief Title
Transplantation of Autologous Bone Marrow or Leukapheresis-Derived Stem Cells for Treatment of Spinal Cord Injury
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stem Cells Arabia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stem Cell Transplantation
Arm Type
Experimental
Arm Description
Injection of leukapheresis-derived, purified, autologous CD34+and CD133+ stem cells
Arm Title
Stem Cells
Arm Type
Experimental
Arm Description
Injection of bone marrow-derived, purified, autologous CD34+and CD133+ stem cells.
Intervention Type
Biological
Intervention Name(s)
Stem Cell Transplantation
Intervention Description
Transplantation of autologous stem cells
Primary Outcome Measure Information:
Title
Overall clinical improvement in sensory and motor functions using ASIA (American Spinal Cord Injury Association)
Time Frame
60 months
Secondary Outcome Measure Information:
Title
Improvement in urine and stool incontinence using a questionnaire
Time Frame
6 months
Title
Functional improvement in impotence and previous sexual erection status (male patients) using a questionnaire
Time Frame
6 months
Title
Improvement in quality of life using a questionnaire
Time Frame
6 months
Title
Improvement in personal independence and productivity using questionnaire
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adeeb AlZoubi, PhD
Phone
00962795337575
Email
adeebalzoubi@stemcellsarabia.net
Facility Information:
Facility Name
Stem Cells Arabia
City
Amman
ZIP/Postal Code
11953
Country
Jordan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adeeb AlZoubi, PhD
Phone
00962795337575
Email
adeebalzoubi@stemcellsarabia.net

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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