Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 11 of 37 for:    stem cell Spinal Cord Injury AND autologous

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02981576
Recruitment Status : Completed
First Posted : December 5, 2016
Last Update Posted : September 24, 2019
Sponsor:
Information provided by (Responsible Party):
Fatima Jamali, University of Jordan

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.


Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Biological: Autologous Mesenchymal Stem Cells Phase 1 Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2016
Actual Primary Completion Date : May 5, 2018
Actual Study Completion Date : January 20, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Recipient of AT-MSC
Patients who will receive Autologous Mesenchymal Stem Cells from AdiposeTissue by Intrathecal injection of stem cells that will be performed 3 times.
Biological: Autologous Mesenchymal Stem Cells
Autologous Mesenchymal Stem Cells will be collected from patients, prepared in the lab and then injected intrathecally.

Active Comparator: Recipient of BM-MSC
Patients who will receive Autologous Mesenchymal Stem Cells from Bone marrow by Intrathecal injection of stem cells that will be performed 3 times.
Biological: Autologous Mesenchymal Stem Cells
Autologous Mesenchymal Stem Cells will be collected from patients, prepared in the lab and then injected intrathecally.




Primary Outcome Measures :
  1. Comparing the number of side effects and the improvement on ASIA Impairment score between SCI patients receiving autologous AT-MSC vs BM-MSC. [ Time Frame: 12 months ]
    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 :
  1. Investigating the number of side effects in SCI patients receiving autologous BM-MSC. [ Time Frame: 12 months ]
    Assessing the number of SCI patients with any relevant side effects observed.

  2. Investigating the effectiveness of autologous BM-MSC in treating SCI patients. [ Time Frame: 12 months ]
    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.

  3. Investigating the number of side effects in SCI patients receiving autologous AT-MSC. [ Time Frame: 12 months ]
    Assessing the number of SCI patients with any relevant side effects observed.

  4. Investigating the effectiveness of autologous AT-MSC in treating SCI patients. [ Time Frame: 12 months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02981576


Locations
Layout table for location information
Jordan
Cell Therapy Center, University of Jordan
Amman, Jordan, 11942
Sponsors and Collaborators
University of Jordan
Investigators
Layout table for investigator information
Study Chair: Abdalla Awidi, MD University of Jordan

Additional Information:
Layout table for additonal information
Responsible Party: Fatima Jamali, Principal Investigator, University of Jordan
ClinicalTrials.gov Identifier: NCT02981576     History of Changes
Other Study ID Numbers: SCIUJCTC
First Posted: December 5, 2016    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Fatima Jamali, University of Jordan:
Spinal Cord Injury
Mesenchymal Stem Cells
Additional relevant MeSH terms:
Layout table for MeSH terms
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System