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

NCT ID: NCT04288934

Last Updated: 2021-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-15
• Study Completion Date: 2020-09-20

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).

Conditions

Spinal Cord Injuries

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Collection and expansion of BM-MSC

Intervention Type: 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

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Collection and expansion of BM-MSC

Intervention Type: 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

Intervention Type: 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.

Interventions

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.

Intervention Type: BIOLOGICAL

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.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Jordan

OTHER

Sponsor Role: lead

Responsible Party

Fatima Jamali

Head of Neuroscience Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cell Therapy Center, University of Jordan

Amman, , Jordan

Countries

Jordan

Other Identifiers

SCICTC

Identifier Type: -

Identifier Source: org_study_id