Stem Cell Therapy in Spinal Cord Injury

Spinal Cord Injury Clinical Trial

Official title:

Open Label Study of Autologous Bone Marrow Mononuclear Cells in Spinal Cord Injury

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02009124
• Other study ID #: NGBSI-03
• Status: Withdrawn
• Phase: Phase 2
• Start date: August 2012
• Est. completion date: December 2018

Study information

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

Clinical Trial Summary

The purpose of this study is to study the effect of stem cell therapy on common symptoms in patients with spinal cord injury.

Description:

Autologous bone marrow mononuclear cells are administered intrathecally by a standard procedure followed by vigorous rehabilitation therapy.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months to 65 Years

Eligibility

Inclusion Criteria:

• Diagnosed cases of any type of spinal cord injury

• age above 12 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.

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

Intervention

Biological:
• Autologous bone marrow mononuclear cell transplantation
Bone marrow is aspirated by a standard procedure. Mononuclear cells are separated by density gradient method and then injected intrathecally by a standard lumbar puncture procedure

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 (5)

Kumar AA, Kumar SR, Narayanan R, Arul K, Baskaran M. Autologous bone marrow derived mononuclear cell therapy for spinal cord injury: A phase I/II clinical safety and primary efficacy data. Exp Clin Transplant. 2009 Dec;7(4):241-8. — View Citation

Sharma A, Gokulchandran N, Chopra G, Kulkarni P, Lohia M, Badhe P, Jacob VC. Administration of autologous bone marrow-derived mononuclear cells in children with incurable neurological disorders and injury is safe and improves their quality of life. Cell Transplant. 2012;21 Suppl 1:S79-90. doi: 10.3727/096368912X633798. — View Citation

Sharma A, Gokulchandran N, Sane H, Badhe P, Kulkarni P, Lohia M, Nagrajan A, Thomas N. Detailed analysis of the clinical effects of cell therapy for thoracolumbar spinal cord injury: an original study. Journal of Neurorestoratology. 2013;1:13-22

Sharma A, Sane H, Gokulchandran N, Kulkarni P, Thomas N, et al. (2013) Role of Autologous Bone Marrow Mononuclear Cells in Chronic Cervical Spinal Cord Injury-A Longterm Follow Up Study. J Neurol Disord 1: 138.

Yoshihara T, Ohta M, Itokazu Y, Matsumoto N, Dezawa M, Suzuki Y, Taguchi A, Watanabe Y, Adachi Y, Ikehara S, Sugimoto H, Ide C. Neuroprotective effect of bone marrow-derived mononuclear cells promoting functional recovery from spinal cord injury. J Neurotrauma. 2007 Jun;24(6):1026-36. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in clinical symptoms of spinal cord injury after 6 months		6 months
Secondary	Functional independence measure (FIM)	It is a standard objective scale used for functional evaluation of the spinal cord injury patients. Its reliability and validity has been well established. It will be marked by a certified occupational therapy expert before the intervention and 6 months after the intervention.	6 months