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

NCT ID: NCT02981576

Last Updated: 2019-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2019-01-20

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.

Conditions

Spinal Cord Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Autologous Mesenchymal Stem Cells

Intervention Type: BIOLOGICAL

Autologous Mesenchymal Stem Cells will be collected from patients, prepared in the lab and then injected intrathecally.

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.

Group Type: ACTIVE_COMPARATOR

Autologous Mesenchymal Stem Cells

Intervention Type: BIOLOGICAL

Autologous Mesenchymal Stem Cells will be collected from patients, prepared in the lab and then injected intrathecally.

Interventions

Autologous Mesenchymal Stem Cells

Autologous Mesenchymal Stem Cells will be collected from patients, prepared in the lab and then injected intrathecally.

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Jordan

OTHER

Sponsor Role: lead

Responsible Party

Fatima Jamali

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abdalla Awidi, MD

Role: STUDY_CHAIR

University of Jordan

Locations

Cell Therapy Center, University of Jordan

Amman, , Jordan

Countries

Jordan

Related Links

http://centers.ju.edu.jo/en/ctc/Home.aspx

Cell Therapy Center Website

Other Identifiers

SCIUJCTC

Identifier Type: -

Identifier Source: org_study_id