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

NCT04288934 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-08-25

No results posted yet for this study

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

Interventions

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 * Blood samples will be withdrawn from patients at 3 months interval for biomarkers detection.

Sponsors & Collaborators

  • University of Jordan

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-15
Primary Completion
2020-04-15
Completion
2020-09-20

Countries

  • Jordan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04288934 on ClinicalTrials.gov