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

Assessment of Safety and Effectiveness of Mesenchymal Stem Cells in the Treatment of Spinal Cord Injury (SCI) Patients.

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.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Biological: Collection and expansion of BM-MSC; Diagnostic test: VI-SCI evaluation and patients' follow up

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• Jordan
  • Amman, Jordan
    • Cell Therapy Center, University of Jordan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Jordan

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 15, 2017
• Primary Completion (ACTUAL): April 15, 2020
• Study Completion (ACTUAL): September 20, 2020

Study Registration Dates

• First Submitted: September 23, 2019
• First Submitted That Met QC Criteria: February 27, 2020
• First Posted (ACTUAL): February 28, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 25, 2021
• Last Update Submitted That Met QC Criteria: August 24, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Mesenchymal Stem Cells; Allogenic; Spinal cord injuries; Bone marrow derived Mesenchymal stem cells; American Spinal Injury Association Impairment Scale
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: SCICTC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No