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

NCT02981576 | Completed Phase 1 DMC

• 1 other identifier: SCIUJCTC
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Keywords

Spinal Cord Injury; Mesenchymal Stem Cells

Outcome Measures

Primary Outcomes (1)

• 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..

  12 months

Secondary Outcomes (4)

• Investigating the number of side effects in SCI patients receiving autologous BM-MSC.

  12 months

• Investigating the effectiveness of autologous BM-MSC in treating SCI patients.

  12 months

• Investigating the number of side effects in SCI patients receiving autologous AT-MSC.

  12 months

• Investigating the effectiveness of autologous AT-MSC in treating SCI patients.

  12 months

Study Arms (2)

Recipient of AT-MSC

ACTIVE COMPARATOR

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

Recipient of BM-MSC

ACTIVE COMPARATOR

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

Interventions

Autologous Mesenchymal Stem Cells BIOLOGICAL

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

Recipient of AT-MSC; Recipient of BM-MSC

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Jordan: lead

Study Sites (1)

Cell Therapy Center, University of Jordan

Amman, 11942, Jordan

Location

Related Links

• Cell Therapy Center Website

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Abdalla Awidi, MD

  University of Jordan

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 1, 2016
• First Posted: December 5, 2016
• Study Start: November 1, 2016
• Primary Completion: May 5, 2018
• Study Completion: January 20, 2019
• Last Updated: September 24, 2019

Record last verified: 2019-09

Locations

JO (1)