Status:
COMPLETED
Outcomes of Autologous Bone Marrow-derived Mononuclear Cell Transplantation in the Management of Neurological Sequelae
Lead Sponsor:
Vinmec Research Institute of Stem Cell and Gene Technology
Conditions:
Sequelae of Injuries of Head
Eligibility:
All Genders
20-50 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of autologous bone marrow-derived mononuclear cell transplantation in the management of neurological sequelae after traumatic brain inj...
Detailed Description
To evaluate the safety and efficacy of autologous bone marrow-derived mononuclear cell transplantation in 25 patients with neurological sequelae after traumatic brain injury compared with 25 patients ...
Eligibility Criteria
Inclusion
- Age: from 20 to 50 years
- Gender: either sex
- Duration after Brain trauma: 6 - 12 months
- Functional Independence Measure - FIM \< 69
- Closed head injury
Exclusion
- Neurologic impairment or neurological disease before the time of the accident.
- Active infections
- Tumours or failure of heart, lung, liver or kidney, respiratory distress syndrome
- Anaemia, clotting disorder
- Cancer
- Pregnancy
- Alcoholic
- Patient was unemployed or did not attend school before the accident.
- Severe injuries: spinal cord injury, pelvic inflammation, cardiopulmonary
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05293873
Start Date
April 1 2021
End Date
June 30 2023
Last Update
October 1 2024
Active Locations (1)
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1
Vinmec Research Institute of Stem Cell and Gene Technology
Hanoi, Hanoi, Vietnam, 100000