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WithdrawnNCT02027246Updated Oct 25, 2018

Safety and Efficacy of Stem Cell Therapy in Spinal Cord Injury

A Phase 1 interventional study of Autologous bone marrow mononuclear cell transplantation in Spinal Cord Injury, sponsored by Neurogen Brain and Spine Institute. Withdrawn at 1 site in India. Open to participants aged 8 Months to 63 Years. Per ClinicalTrials.gov, last updated 2018-10-25.

Sponsored by Neurogen Brain and Spine Institute · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
8 Months to 63 Years
Sex
All
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Spinal Cord Injury

Keywords

  • spinal cord injury
  • autologous bone marrow mononuclear cells
  • stem cell therapy
03

In context

Spinal Cord Injuries

1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.

Browse Spinal Cord Injuries studies →

Lead sponsor

Neurogen Brain and Spine Institute is the lead sponsor of 16 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Months to 63 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosed cases of any type of chronic Spinal cord injury
  • Age above 6 months

Exclusion criteria

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Stem cell

    Autologous bone marrow mononuclear cell transplantation

    Biological: Autologous bone marrow mononuclear cell transplantation

Interventions

  • BiologicalAutologous 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

06

What researchers measure

Primary outcomes

  1. Change in clinical symptoms

    clinical symptoms were assessed based on the observation of the experts

    Time frame: 6 months

Secondary outcomes

  1. 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.

    Time frame: 6 months

07

Study locations

1 site
  • Neurogen brain and spine institute
    Mumbai, Maharashtra 400071, India
08

References and documents

Publications

  • 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. PubMed 20353375 ↗
  • 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. doi: 10.1089/neu.2007.132R. PubMed 17600518 ↗
  • 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. PubMed 22507683 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 25, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02027246
Lead sponsor
Neurogen Brain and Spine Institute
Responsible party
Sponsor
First posted
Jan 6, 2014
Start date
Dec 2008
Primary completion
Aug 2012
Completion
Feb 2013
Last update
Oct 25, 2018

Study contacts

Alok K Sharma, M.S., M.Ch
principal investigator · Neurogen Brain and Spine Institute

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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