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

NCT05293873 | Completed Phase 1 DMC

• 1 other identifier: VinmecISC1805
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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 injury

Conditions

Sequelae of Injuries of Head

Keywords

traumatic brain injury; mononuclear cell; neurological sequelae

Outcome Measures

Primary Outcomes (3)

• Adverse events and serious adverse events

  Incidence of the adverse events or serious adverse events after transplantation

  up to the 12-month period following treatment

• Functional Independence Measure

  Functional Independence Measure assess and grade the functional status of patient

  up to the 12-month period following treatment

• Extended Glasgow Outcome Scale

  Extended Glasgow Outcome Scale classifies global outcome in TBI survivors

  up to the 12-month period following treatment

Secondary Outcomes (2)

• Short Form 36

  up to the 12-month period following treatment

• to monitor the functional metabolic changes in the brain of the patients

  up to the 12 months after transplantation

Study Arms (2)

Treatment (BM-MNC trasnplatation)

EXPERIMENTAL

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

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

Control group

OTHER

rehabilitation therapy

Other: Rehabilitation therapy

Interventions

Rehabilitation therapy OTHER

Rehabilitation therapy

Control group; Treatment (BM-MNC trasnplatation)

autologous bone marrow-derived mononuclear cell transplantation BIOLOGICAL

Bm-MNC will be transplanted at baseline, and the second transplantation will be performed 6 months after the first transplantation

Treatment (BM-MNC trasnplatation)

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age: from 20 to 50 years
• Gender: either sex
• Duration after Brain trauma: 6 - 12 months
• Functional Independence Measure - FIM \< 69
• Closed head injury

You may not qualify if:

• 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

Sponsors & Collaborators

• Vinmec Research Institute of Stem Cell and Gene Technology: lead

Study Sites (1)

Vinmec Research Institute of Stem Cell and Gene Technology

Hanoi, Hanoi, 100000, Vietnam

Location

Related Publications (5)

• Nguyen TL, Nguyen HP, Nguyen TK. The effects of bone marrow mononuclear cell transplantation on the quality of life of children with cerebral palsy. Health Qual Life Outcomes. 2018 Aug 14;16(1):164. doi: 10.1186/s12955-018-0992-x.

  PMID: 30107811 BACKGROUND

• Nguyen LT, Nguyen AT, Vu CD, Ngo DV, Bui AV. Outcomes of autologous bone marrow mononuclear cells for cerebral palsy: an open label uncontrolled clinical trial. BMC Pediatr. 2017 Apr 12;17(1):104. doi: 10.1186/s12887-017-0859-z.

  PMID: 28403842 BACKGROUND

• Eggenberger S, Boucard C, Schoeberlein A, Guzman R, Limacher A, Surbek D, Mueller M. Stem cell treatment and cerebral palsy: Systemic review and meta-analysis. World J Stem Cells. 2019 Oct 26;11(10):891-903. doi: 10.4252/wjsc.v11.i10.891.

  PMID: 31692977 BACKGROUND

• Bansal H, Verma P, Agrawal A, Leon J, Sundell IB, Koka PS. A Short Study Report on Bone Marrow Aspirate Concentrate Cell Therapy in Ten South Asian Indian Patients with Autism. J Stem Cells. 2016;11(1):25-36.

  PMID: 28296862 BACKGROUND

• Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14.

  PMID: 17370477 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2019
• First Posted: March 24, 2022
• Study Start: April 1, 2021
• Primary Completion: March 30, 2023
• Study Completion: June 30, 2023
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)