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

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04288934
• Other study ID #: SCICTC
• Status: Completed
• Phase: Phase 1
• Start date: August 15, 2017
• Est. completion date: September 20, 2020

Study information

• Verified date: August 2021
• Source: University of Jordan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 20, 2020
• Est. primary completion date: April 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
Jordan	Cell Therapy Center, University of Jordan	Amman

Sponsors (1)

Lead Sponsor	Collaborator
University of Jordan

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	SCI evaluation and MSCs transplantation	post MSCs transplantation, patients' spine will be imaged using 3 Tesla MRI and compared to baseline.	6-12 months