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NCT02028104 Clinical Trial

Stem Cell Therapy in Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02028104
Other study ID # NGBSI-06
Secondary ID
Status Withdrawn
Phase Phase 1
First received
Last updated
Start date January 2010
Est. completion date September 2016

Study information
Verified date October 2018
Source Neurogen Brain and Spine Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date September 2016
Est. primary completion date April 2016
Accepts healthy volunteers No
Gender All
Age group 6 Months to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Autologous bone marrow mononuclear cell transplantation
bone marrow derived mononuclear cells are administered intrathecally in traumatic brain injury patients

Locations
Country Name City State
India Neurogen brain and spine institute Mumbai Maharashtra

Sponsors (1)
Lead Sponsor Collaborator
Neurogen Brain and Spine Institute

Country where clinical trial is conducted

India, 

References & Publications (2)

Lee DH, Lee JY, Oh BM, Phi JH, Kim SK, Bang MS, Kim SU, Wang KC. Functional recovery after injury of motor cortex in rats: effects of rehabilitation and stem cell transplantation in a traumatic brain injury model of cortical resection. Childs Nerv Syst. 2013 Mar;29(3):403-11. doi: 10.1007/s00381-012-1969-4. Epub 2012 Nov 24. — View Citation

Tian C, Wang X, Wang X, Wang L, Wang X, Wu S, Wan Z. Autologous bone marrow mesenchymal stem cell therapy in the subacute stage of traumatic brain injury by lumbar puncture. Exp Clin Transplant. 2013 Apr;11(2):176-81. doi: 10.6002/ect.2012.0053. Epub 2012 Aug 11. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Other SF-8 scale 6 months
Primary Change in clinical symptoms of traumatic brain injury 6 months
Secondary Disability Rating scale 6 months
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