Outcomes of Autologous Bone Marrow-derived Mononuclear Cell Transplantation in the Management of Neurological Sequelae

Vinmec Research Institute of Stem Cell and Gene Technology

Status and phase: Completed; Phase 2; Phase 1

Conditions: Sequelae of Injuries of Head

Treatments: Other: Rehabilitation therapy; Biological: autologous bone marrow-derived mononuclear cell transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT05293873

VinmecISC1805

Details and patient eligibility

About

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 injury

Full 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 in control group (no intervention) at the time points of baseline, 3rd month (D90), 6th month (D180), and 12th month (D360).

Enrollment: 50 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Treatment (BM-MNC trasnplatation)

Experimental group

Description:

Autologous bone marrow-derived mononuclear cell will transplant at baseline, and the second transplantation will be performed 6 months after the first transplantation and combination with rehabilitation therapy

Treatment:

Biological: autologous bone marrow-derived mononuclear cell transplantation

Other: Rehabilitation therapy

Control group

Other group

Description:

rehabilitation therapy

Treatment:

Other: Rehabilitation therapy