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

Primary Purpose

Spinal Cord Injuries

Status
Completed
Phase
Phase 1
Locations
Jordan
Study Type
Interventional
Intervention
Collection and expansion of BM-MSC
VI-SCI evaluation and patients' follow up
Sponsored by
University of Jordan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Spinal cord injuries, Mesenchymal Stem Cells, Allogenic, Bone marrow derived Mesenchymal stem cells, American Spinal Injury Association Impairment Scale

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cell Therapy Center, University of Jordan

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

patients with complete transection of the spinal cord

patients with SCI without total transaction.

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 23, 2019
Last Updated
August 24, 2021
Sponsor
University of Jordan
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1. Study Identification

Unique Protocol Identification Number
NCT04288934
Brief Title
Treatment of Spinal Cord Injuries With (AutoBM-MSCs)vs (WJ-MSCs).
Official Title
Assessment of Safety and Effectiveness of Mesenchymal Stem Cells in the Treatment of Spinal Cord Injury (SCI) Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
August 15, 2017 (Actual)
Primary Completion Date
April 15, 2020 (Actual)
Study Completion Date
September 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jordan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
Spinal cord injuries, Mesenchymal Stem Cells, Allogenic, Bone marrow derived Mesenchymal stem cells, American Spinal Injury Association Impairment Scale

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patients with complete transection of the spinal cord
Arm Type
Active Comparator
Arm Description
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.
Arm Title
patients with SCI without total transaction.
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Collection and expansion of BM-MSC
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
VI-SCI evaluation and patients' follow up
Intervention Description
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 Measure Information:
Title
SCI evaluation and patients follow up
Description
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.
Time Frame
3 months
Title
SCI evaluation and MSCs transplantation
Description
post MSCs transplantation, patients' spine will be imaged using 3 Tesla MRI and compared to baseline.
Time Frame
6-12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Cell Therapy Center, University of Jordan
City
Amman
Country
Jordan

12. IPD Sharing Statement

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

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