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

NCT04288934 | Completed Phase 1 DMC

• 1 other identifier: SCICTC
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Keywords

Spinal cord injuries; Mesenchymal Stem Cells; Allogenic; Bone marrow derived Mesenchymal stem cells; American Spinal Injury Association Impairment Scale

Outcome Measures

Primary Outcomes (2)

• 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 blood samples will be withdrawn from patients as well to detect any biomarkers.

  3 months

• SCI evaluation and MSCs transplantation

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

  6-12 months

Study Arms (2)

patients with complete transection of the spinal cord

ACTIVE COMPARATOR

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

patients with SCI without total transaction.

ACTIVE COMPARATOR

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

Interventions

Collection and expansion of BM-MSC 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.

patients with SCI without total transaction.; patients with complete transection of the spinal cord

VI-SCI evaluation and patients' follow up 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.; patients with complete transection of the spinal cord

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Jordan: lead

Study Sites (1)

Cell Therapy Center, University of Jordan

Amman, Jordan

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Neuroscience Research

Model Details: 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.

Study Record Dates

• First Submitted: September 23, 2019
• First Posted: February 28, 2020
• Study Start: August 15, 2017
• Primary Completion: April 15, 2020
• Study Completion: September 20, 2020
• Last Updated: August 25, 2021

Record last verified: 2021-08

Locations

JO (1)