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

Spinal Cord Injuries Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02981576
• Other study ID #: SCIUJCTC
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: November 2016
• Est. completion date: January 20, 2019

Study information

• Verified date: September 2019
• Source: University of Jordan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: January 20, 2019
• Est. primary completion date: May 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Spinal Cord Injuries

Intervention

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

Locations

Country	Name	City	State
Jordan	Cell Therapy Center, University of Jordan	Amman

Sponsors (1)

Lead Sponsor	Collaborator
University of Jordan

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	12 months
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	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.	12 months

External Links

•   Cell Therapy Center Website