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NCT Number: NCT02981576

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

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Cell Therapy Center, University of Jordan

Amman, 11942, Jordan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Autologous mesenchymal stem cells

Biological

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

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.

    Time frame: 12 months

    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..

Secondary outcomes

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

    Time frame: 12 months

    Assessing the number of SCI patients with any relevant side effects observed.

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

    Time frame: 12 months

    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.

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

    Time frame: 12 months

    Assessing the number of SCI patients with any relevant side effects observed.

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

    Time frame: 12 months

    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.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

University of Jordan

Other

Registry information

Official study 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.

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Dec 5, 2016
Registry last updated
Sep 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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