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

University of Jordan

Status and phase

Completed

Phase 2

Phase 1

Conditions

Spinal Cord Injuries

Treatments

Biological: Autologous Mesenchymal Stem Cells

Study type

Interventional

Funder types

Other

Identifiers

NCT02981576

SCIUJCTC

Details and patient eligibility

About

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.

Full 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.

Enrollment

14 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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.