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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04288934
Recruitment Status : Completed
First Posted : February 28, 2020
Last Update Posted : August 25, 2021
Sponsor:
Information provided by (Responsible Party):
Fatima Jamali, University of Jordan

Tracking Information
First Submitted Date  ICMJE September 23, 2019
First Posted Date  ICMJE February 28, 2020
Last Update Posted Date August 25, 2021
Actual Study Start Date  ICMJE August 15, 2017
Actual Primary Completion Date April 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 28, 2020)
  • 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 blood samples will be withdrawn from patients as well to detect any biomarkers.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 27, 2020)
  • SCI evaluation [ Time Frame: 3 months ]
    The Spinal Cord Independence Measure (SCIM III) score
  • SCI evaluation [ Time Frame: 6-12 months ]
    post MSCs transplantation, patients' spine will be imaged using 3 Tesla MRI
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Spinal Cord Injuries With (AutoBM-MSCs)vs (WJ-MSCs).
Official Title  ICMJE Assessment of Safety and Effectiveness of Mesenchymal Stem Cells in the Treatment of Spinal Cord Injury (SCI) Patients.
Brief Summary 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.
Detailed Description 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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Patients with complete transection of the spinal cord. Each group will then be subdivided into 2 subgroups with of 5 patients each; the 1st subgroup will be the patients with chronic SCI and the 2nd subgroup will be for the patients with subacute SCI.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Spinal Cord Injuries
Intervention  ICMJE
  • Biological: Collection and expansion of BM-MSC
    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.
  • Diagnostic Test: VI-SCI evaluation and patients' follow up
    • 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.
Study Arms  ICMJE
  • Active Comparator: patients with complete transection of the spinal cord
    This group of patients with complete transection of the spinal cord group will then be subdivided into 2 subgroups with of 5 patients each; the 1st subgroup will be the patients with chronic SCI and the 2nd subgroup will be for the patients with subacute SCI. All patients will receive AutoBM-MSCs by a specialized spine surgeon into the spinal medulla.
    Interventions:
    • Biological: Collection and expansion of BM-MSC
    • Diagnostic Test: VI-SCI evaluation and patients' follow up
  • Active Comparator: patients with SCI without total transaction.
    This group will then be subdivided into 2 subgroups with of 5 patients each; the 1st subgroup will be the patients with chronic SCI and the 2nd subgroup will be for the patients with subacute SCI. All patients will receive WJ-MSCs by a specialized spine surgeon into the spinal medulla.
    Interventions:
    • Biological: Collection and expansion of BM-MSC
    • Diagnostic Test: VI-SCI evaluation and patients' follow up
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 27, 2020)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 20, 2020
Actual Primary Completion Date April 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Jordan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04288934
Other Study ID Numbers  ICMJE SCICTC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Fatima Jamali, University of Jordan
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Jordan
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Jordan
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP