Clinical trial NCT04288934: Treatment of Spinal Cord Injuries With (AutoBM-MSCs)vs (WJ-MSCs).
Official title: Assessment of Safety and Effectiveness of Mesenchymal Stem Cells in the Treatment of Spinal Cord Injury (SCI) Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Spinal Cord Injuries
Keywords: Spinal cord injuries
Mesenchymal Stem Cells
Allogenic
Bone marrow derived Mesenchymal stem cells
American Spinal Injury Association Impairment Scale
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2020-02-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: SCI evaluation and patients follow up
timeFrame: 3 months
measure: SCI evaluation and MSCs transplantation
timeFrame: 6-12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Cell Therapy Center, University of Jordan
Study officials:
References: