Stem Cell Therapy in Traumatic Brain Injury

Open Label Study of Autologous Bone Marrow Mononuclear Cells in Traumatic Brain Injury

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02028104

Enrollment

Registered

2014-01-06

Start date

2010-01-31

Completion date

2016-09-30

Last updated

2018-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury

Brief summary

The purpose of this study was to study the effect of stem cell therapy on common symptoms in patients with Traumatic Brain Injury

Interventions

BIOLOGICALAutologous bone marrow mononuclear cell transplantation

bone marrow derived mononuclear cells are administered intrathecally in traumatic brain injury patients

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Months to 65 Years

Healthy volunteers

Inclusion criteria

* Diagnosed cases of chronic traumatic brain injury * Age above 6 months

Exclusion criteria

* presence of acute infections such as Human immunodeficiency virus/Hepatitis B - Virus/Hepatitis C Virus * malignancies * bleeding tendencies * pneumonia * renal failure * severe liver dysfunction * severe anemia \[Hemoglobin \< 8\] * any bone marrow disorder * space occupying lesion in brain * other acute medical conditions such as respiratory infection and pyrexia * pregnancy * lactation

Design outcomes

Primary

Measure	Time frame
Change in clinical symptoms of traumatic brain injury	6 months

Secondary

Measure	Time frame
Disability Rating scale	6 months

Other

Measure	Time frame
SF-8 scale	6 months

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026