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

Phase 1

Completed

• Conditions: Spinal Cord Injuries
• Interventions: Biological: Collection and expansion of BM-MSC; Diagnostic Test: VI-SCI evaluation and patients' follow up

• Registration Number: NCT04288934
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2017-08-15
• Study First Submitted: 2019-09-23
• Study First Submitted QC: 2020-02-27
• Study First Posted: 2020-02-28
• Primary Completion: 2020-04-15
• Study Completion: 2020-09-20
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-24
• Last Update Posted: 2021-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
patients with complete transection of the spinal cord	Collection and expansion of BM-MSC	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.
patients with complete transection of the spinal cord	VI-SCI evaluation and patients' follow up	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.
patients with SCI without total transaction.	Collection and expansion of BM-MSC	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.
patients with SCI without total transaction.	VI-SCI evaluation and patients' follow up	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Cell Therapy Center, University of Jordan; 🇯🇴 Amman, Jordan