Safety and Efficacy of Stem Cell Therapy in Spinal Cord Injury

Spinal Cord Injury Clinical Trial

Official title:

Autologous Bone Marrow Mononuclear Cell Therapy for Spinal Cord Injury

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02027246
• Other study ID #: NGBSI-05
• Status: Withdrawn
• Phase: Phase 1
• Start date: December 2008
• Est. completion date: February 2013

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 aim of this study was to study the effect of stem cell therapy on common symptoms of spinal cord injury patients.

Description:

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2013
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Months to 63 Years

Eligibility

Inclusion Criteria:

• Diagnosed cases of any type of chronic Spinal cord 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

• other acute medical conditions such as respiratory infection

• pregnancy and lactation

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 (3)

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

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	clinical symptoms were assessed based on the observation of the experts	6 months
Secondary	Functional Independence Measure (FIM)	Functional Independence Measure (FIM) is a standard scale performed before and 6 months after the intervention to measure the functional ability of the patients.	6 months