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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04288934
Recruitment Status : Recruiting
First Posted : February 28, 2020
Last Update Posted : March 3, 2020
Sponsor:
Information provided by (Responsible Party):
Fatima Jamali, University of Jordan

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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Biological: Collection and expansion of BM-MSC Diagnostic Test: VI-SCI evaluation and patients' follow up Phase 1

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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
Official Title: Assessment of Safety and Effectiveness of Mesenchymal Stem Cells in the Treatment of Spinal Cord Injury (SCI) Patients.
Actual Study Start Date : August 15, 2017
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.

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.
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.




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04288934


Contacts
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Contact: Abdulrahman shdefat, PhD 0796371254 A.Shudifat@ju.edu.jo

Locations
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Jordan
Cell Therapy Center, University of Jordan Recruiting
Amman, Jordan
Contact: Abdullah Aweidi, PhD         
Contact: Wael Adwan, PhD         
Sponsors and Collaborators
University of Jordan
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Responsible Party: Fatima Jamali, Head of Neuroscience Research, University of Jordan
ClinicalTrials.gov Identifier: NCT04288934    
Other Study ID Numbers: SCICTC
First Posted: February 28, 2020    Key Record Dates
Last Update Posted: March 3, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fatima Jamali, University of Jordan:
Spinal cord injuries
Mesenchymal Stem Cells
Allogenic
Bone marrow derived Mesenchymal stem cells
American Spinal Injury Association Impairment Scale
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System