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

Outcomes of Autologous Bone Marrow-derived Mononuclear Cell Transplantation in the Management of Neurological Sequelae After Traumatic Brain Injury

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

Study Overview

• Status: Recruiting
• Conditions: Sequelae of Injuries of Head
• Intervention / Treatment: Biological: autologous bone marrow-derived mononuclear cell transplantation; Other: Rehabilitation therapy

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

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Kien T Nguyen, Msc; Phone Number: (+84)386958552; Email: v.kiennt25@vinmec.com

Study Locations

• Vietnam
  • Hanoi, Vietnam, 100000
    • Recruiting
    • Vinmec Research Institute of Stem Cell and Gene Technology
    • Contact: Nguyen T Liem, Prof

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment (BM-MNC trasnplatation); 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; Bm-MNC will be transplanted at baseline, and the second transplantation will be performed 6 months after the first transplantation; Other: Rehabilitation therapy; Rehabilitation therapy
Other: Control group; rehabilitation therapy	Other: Rehabilitation therapy; Rehabilitation therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short Form 36	Short Form 36 items will be performed to evaluate the overall health of the patients for their quality of life	up to the 12-month period following treatment
to monitor the functional metabolic changes in the brain of the patients	The PET-CT scan will be repeated to monitor the functional metabolic changes in the brain of the patients	up to the 12 months after transplantation

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.
• Cox CS Jr, Hetz RA, Liao GP, Aertker BM, Ewing-Cobbs L, Juranek J, Savitz SI, Jackson ML, Romanowska-Pawliczek AM, Triolo F, Dash PK, Pedroza C, Lee DA, Worth L, Aisiku IP, Choi HA, Holcomb JB, Kitagawa RS. Treatment of Severe Adult Traumatic Brain Injury Using Bone Marrow Mononuclear Cells. Stem Cells. 2017 Apr;35(4):1065-1079. doi: 10.1002/stem.2538. Epub 2016 Nov 23.
• Sharma A, Sane H, Kulkarni P, Yadav J, Gokulchandran N, Biju H, Badhe P. Cell therapy attempted as a novel approach for chronic traumatic brain injury - a pilot study. Springerplus. 2015 Jan 17;4:26. doi: 10.1186/s40064-015-0794-0. eCollection 2015.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Anticipated): March 30, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: March 27, 2019
• First Submitted That Met QC Criteria: March 14, 2022
• First Posted (Actual): March 24, 2022

Study Record Updates

• Last Update Posted (Actual): March 24, 2022
• Last Update Submitted That Met QC Criteria: March 14, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: traumatic brain injury; mononuclear cell; neurological sequelae
• Additional Relevant MeSH Terms: Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Craniocerebral Trauma
• Other Study ID Numbers: VinmecISC1805

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No