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Completed

NCT Number: NCT04288934

Treatment of Spinal Cord Injuries With (AutoBM-MSCs)vs (WJ-MSCs).

This study aims to assess and compare the safety and effectiveness of Autologous Bone Marrow-Derived MSCs (AutoBM-MSCs) in one group(group A) of SCI who are unlikely to be able to walk independently without treatment after 1 year of SCI, in the other group (group B) to assess the second group of Wharton Jelly derived mesenchymal stem cells ( WJ-MSCs) in the treatment of acute and subacute spinal cord injury (SCI) 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

Primary location

Cell Therapy Center, University of Jordan

Amman, Jordan

About this study

The study will be directed by the Cell Therapy Center (CTC) in Jordan, where 20 SCI patients meeting the inclusion criteria will be recruited and divided according to the type of injury into two groups; Group A for patients with complete transection of the spinal cord, and Group B for SCI without a total transaction,10 patients will receive (AutoBM-MSCs)and the other 10 patients with acute and subacute spinal cord injury will receive(WJ-MSCs) by a specialized spine surgeon into the spinal medulla. The outcomes and improvements will be assessed using the American Spinal Injury Association (ASIA) Impairment Scale (AIS) and the Spinal Cord Independence Measure (SCIM) version III, in addition to blood tests, MRI, and somatosensory evoked potential (SSEP).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age: 18-70 years
  • Complete SCI grade AIS-A or -B, or incomplete C
  • SCI between cervical levels C5 and thoracic level T11
  • At least 12 weeks since time of injury
  • Prediction rule score of 10 or less
  • Cognitively unaffected
  • Motivated for stem cell transplantation

Exclusion criteria

  • Reduced cognition
  • Age under 18 years or 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 HIV, HBV, 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 MRI.
  • Other medical conditions which can interfere with stem cell transplantation
  • Inability to provide informed consent.
  • Uncorrected vision
  • Cardiac abnormalities and uncontrolled hypertension

Treatment and study plan

Collection and expansion of BM-MSC

Biological

MSCs collection from patients owns marrow using a volume of 20 ml of bone marrow obtained from iliac crest of SCI patients under local anesthesia. Manipulations of blood and bone marrow are to be done according to Good Laboratory Practice (GLP) using the gradient sedimentation method.

VI-SCI evaluation and patients' follow up

Diagnostic Test
  • At 6, and 12 months post MSCs transplantation, patients' spine will be imaged using 3 Tesla MRI and compared to baseline.
  • The (ASIA)/(ISNCSCI) score will be repeated every 3 months to evaluate any motor or neurological changes
  • The Spinal Cord Independence Measure (SCIM III) score will be repeated every 3 months to evaluate the effect on daily activities.
  • Blood samples will be withdrawn from patients at 3 months interval for biomarkers detection.

Primary outcomes

  1. SCI evaluation and patients follow up

    Time frame: 3 months

    the (ASIA)/(ISNCSCI) to evaluate any motor or neurological changes, and the spinal cord independence measure (SCIM III) score to evaluate the effect on daily activities .these tests will be repeated every 3 months.

    blood samples will be withdrawn from patients as well to detect any biomarkers.

  2. SCI evaluation and MSCs transplantation

    Time frame: 6-12 months

    post MSCs transplantation, patients' spine will be imaged using 3 Tesla MRI and compared to baseline.

Sponsors and collaborators

Lead sponsor

University of Jordan

Other

Registry information

Official study title

Assessment of Safety and Effectiveness of Mesenchymal Stem Cells in the Treatment of Spinal Cord Injury (SCI) Patients.

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Feb 28, 2020
Registry last updated
Aug 25, 2021

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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