Clinical trial NCT02981576: Safety and Effectiveness of BM-MSC vs AT-MSC in the Treatment of SCI Patients.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Spinal Cord Injuries
Keywords: Spinal Cord Injury
Mesenchymal Stem Cells
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2016-12-05
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Comparing the number of side effects and the improvement on ASIA Impairment score between SCI patients receiving autologous AT-MSC vs BM-MSC.
timeFrame: 12 months
Secondary outcomes:
measure: Investigating the number of side effects in SCI patients receiving autologous BM-MSC.
timeFrame: 12 months
measure: Investigating the effectiveness of autologous BM-MSC in treating SCI patients.
timeFrame: 12 months
measure: Investigating the number of side effects in SCI patients receiving autologous AT-MSC.
timeFrame: 12 months
measure: Investigating the effectiveness of autologous AT-MSC in treating SCI patients.
timeFrame: 12 months
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Cell Therapy Center, University of Jordan
Study officials:
affiliation: University of Jordan
name: Abdalla Awidi, MD
role: STUDY_CHAIR
References: