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Safety and Effectiveness of BM-MSC vs AT-MSC in the Treatment of SCI Patients.

Primary Purpose

Spinal Cord Injuries

Status
Completed
Phase
Phase 1
Locations
Jordan
Study Type
Interventional
Intervention
Autologous Mesenchymal Stem Cells
Sponsored by
University of Jordan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Spinal Cord Injury, Mesenchymal Stem Cells

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Complete spinal cord injury grade AIS-A or -B, or incomplete C
  • At least 2 weeks since time of injury
  • Cognitively unaffected
  • Motivated for stem cell transplantation

Exclusion Criteria:

  • Reduced cognition
  • Age under 18 years of above 70 years
  • Significant osteoporosis in spine and/or joints
  • Pregnancy (Adequate contraceptive use is required for women in fertile age)
  • Anoxic brain injury
  • Neurodegenerative diseases
  • Evidence of meningitis
  • Positive serology for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Syphilis.
  • Medical Complications that contraindicate surgery, including major respiratory complications.
  • Use of metal implants close to vascular structures (such as cardiac pacemaker or prosthesis) that contraindicate Magnetic resonance imaging (MRI).
  • Other medical conditions which can interfere with stem cell transplantation
  • Inability to provide informed consent.

Sites / Locations

  • Cell Therapy Center, University of Jordan

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Recipient of AT-MSC

Recipient of BM-MSC

Arm Description

Patients who will receive Autologous Mesenchymal Stem Cells from AdiposeTissue by Intrathecal injection of stem cells that will be performed 3 times.

Patients who will receive Autologous Mesenchymal Stem Cells from Bone marrow by Intrathecal injection of stem cells that will be performed 3 times.

Outcomes

Primary Outcome Measures

Comparing the number of side effects and the improvement on ASIA Impairment score between SCI patients receiving autologous AT-MSC vs BM-MSC.
Comparing the number of SCI patients with any relevant side effects observed and the measured outcome in each arm by follow up Magnetic Resonance Imaging (MRI) and clinical signs and symptoms using ASIA scoring system..

Secondary Outcome Measures

Investigating the number of side effects in SCI patients receiving autologous BM-MSC.
Assessing the number of SCI patients with any relevant side effects observed.
Investigating the effectiveness of autologous BM-MSC in treating SCI patients.
Assessing the therapeutic benefits of the injected Autologous BM-MSC by follow up Magnetic Resonance Imaging (MRI) and clinical signs and symptoms using ASIA scoring system.
Investigating the number of side effects in SCI patients receiving autologous AT-MSC.
Assessing the number of SCI patients with any relevant side effects observed.
Investigating the effectiveness of autologous AT-MSC in treating SCI patients.
Assessing the therapeutic benefits of the injected Autologous AT-MSC by follow up Magnetic Resonance Imaging (MRI) and clinical signs and symptoms using ASIA scoring system.

Full Information

First Posted
December 1, 2016
Last Updated
September 23, 2019
Sponsor
University of Jordan
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1. Study Identification

Unique Protocol Identification Number
NCT02981576
Brief Title
Safety and Effectiveness of BM-MSC vs AT-MSC in the Treatment of SCI Patients.
Official Title
Comparative Evaluation of Safety and Effectiveness of Autologous Bone Marrow Derived Mesenchymal Stem Cells (BM-MSC) vs Adipose Tissue Derived Mesenchymal Stem Cells (AT-MSC) in the Treatment of Spinal Cord Injury (SCI) Patient.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
May 5, 2018 (Actual)
Study Completion Date
January 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jordan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Spinal Cord Injury (SCI) is a devastating condition that leads to permanent functional and neurological deficits in injured individuals. The limited ability of the Central Nervous System (CNS) to spontaneously regenerate impairs axonal regeneration and functional recovery of the spinal cord. The leading causes are motor-vehicle crashes, sports-associated accidents, falls, and violence-related injuries. Unfortunately, there is still no effective clinical treatment for SCI. In recent years, tissue engineering and regenerative medicine based approaches have been proposed as alternatives for SCI repair/regeneration. Mesnchymal stem cells (MSC) use in SCI showed promising results in several studies. Our aim is to assess and compare the safety and effectiveness of autologous BM-MSC vs autologous AT-MSC in these patients.
Detailed Description
The study will be conducted at Cell Therapy Center (CTC) in Jordan, where 14 SCI patients meeting the inclusion criteria will be recruited and blindly divided into 2 groups of equal numbers. The first groups will be treated with autologous BM-MSC, while the second group will be treated with autologous AT-MSC. The outcomes and improvements will be assessed using the American Spinal Injury Association (ASIA) Impairment Scale (AIS). Magnetic Resonance Imaging (MRI) will be performed at base line and after 12 months of the stem cell transplantation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
Spinal Cord Injury, Mesenchymal Stem Cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Recipient of AT-MSC
Arm Type
Active Comparator
Arm Description
Patients who will receive Autologous Mesenchymal Stem Cells from AdiposeTissue by Intrathecal injection of stem cells that will be performed 3 times.
Arm Title
Recipient of BM-MSC
Arm Type
Active Comparator
Arm Description
Patients who will receive Autologous Mesenchymal Stem Cells from Bone marrow by Intrathecal injection of stem cells that will be performed 3 times.
Intervention Type
Biological
Intervention Name(s)
Autologous Mesenchymal Stem Cells
Intervention Description
Autologous Mesenchymal Stem Cells will be collected from patients, prepared in the lab and then injected intrathecally.
Primary Outcome Measure Information:
Title
Comparing the number of side effects and the improvement on ASIA Impairment score between SCI patients receiving autologous AT-MSC vs BM-MSC.
Description
Comparing the number of SCI patients with any relevant side effects observed and the measured outcome in each arm by follow up Magnetic Resonance Imaging (MRI) and clinical signs and symptoms using ASIA scoring system..
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Investigating the number of side effects in SCI patients receiving autologous BM-MSC.
Description
Assessing the number of SCI patients with any relevant side effects observed.
Time Frame
12 months
Title
Investigating the effectiveness of autologous BM-MSC in treating SCI patients.
Description
Assessing the therapeutic benefits of the injected Autologous BM-MSC by follow up Magnetic Resonance Imaging (MRI) and clinical signs and symptoms using ASIA scoring system.
Time Frame
12 months
Title
Investigating the number of side effects in SCI patients receiving autologous AT-MSC.
Description
Assessing the number of SCI patients with any relevant side effects observed.
Time Frame
12 months
Title
Investigating the effectiveness of autologous AT-MSC in treating SCI patients.
Description
Assessing the therapeutic benefits of the injected Autologous AT-MSC by follow up Magnetic Resonance Imaging (MRI) and clinical signs and symptoms using ASIA scoring system.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Complete spinal cord injury grade AIS-A or -B, or incomplete C At least 2 weeks since time of injury Cognitively unaffected Motivated for stem cell transplantation Exclusion Criteria: Reduced cognition Age under 18 years of above 70 years Significant osteoporosis in spine and/or joints Pregnancy (Adequate contraceptive use is required for women in fertile age) Anoxic brain injury Neurodegenerative diseases Evidence of meningitis Positive serology for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Syphilis. Medical Complications that contraindicate surgery, including major respiratory complications. Use of metal implants close to vascular structures (such as cardiac pacemaker or prosthesis) that contraindicate Magnetic resonance imaging (MRI). Other medical conditions which can interfere with stem cell transplantation Inability to provide informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdalla Awidi, MD
Organizational Affiliation
University of Jordan
Official's Role
Study Chair
Facility Information:
Facility Name
Cell Therapy Center, University of Jordan
City
Amman
ZIP/Postal Code
11942
Country
Jordan

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Links:
URL
http://centers.ju.edu.jo/en/ctc/Home.aspx
Description
Cell Therapy Center Website

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Safety and Effectiveness of BM-MSC vs AT-MSC in the Treatment of SCI Patients.

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