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

Sponsor

University of Jordan (Other)

Overall Status

Completed

CT.gov ID

NCT04288934

Collaborator

(none)

Enrollment

Location

Arms

37.2

Actual Duration (Months)

0.5

Patients Per Site Per Month

Study Details

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.

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).

Study Design

Study Type:

Interventional

Actual 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.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 :

Aug 15, 2017

Actual Primary Completion Date :

Apr 15, 2020

Actual Study Completion Date :

Sep 20, 2020

Arms and Interventions

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.

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

Diagnostic Test: VI-SCI evaluation and patients' follow up

Outcome Measures

Primary Outcome Measures

SCI evaluation and patients follow up [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 [6-12 months]
post MSCs transplantation, patients' spine will be imaged using 3 Tesla MRI and compared to baseline.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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