NCT02009124

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2012

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 2, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 11, 2013

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

October 25, 2018

Status Verified

October 1, 2018

Enrollment Period

5.8 years

First QC Date

December 2, 2013

Last Update Submit

October 23, 2018

Conditions

Spinal Cord Injury

Keywords

spinal cord injurystem cell therapybone marrowmononuclear cellsautologous

Outcome Measures

Primary Outcomes (1)

  • Change in clinical symptoms of spinal cord injury after 6 months

    6 months

Secondary Outcomes (1)

  • Functional independence measure (FIM)

    6 months

Study Arms (2)

Stem cell

EXPERIMENTAL

autologous bone marrow mononuclear cell transplantation

Biological: Autologous bone marrow mononuclear cell transplantation

Control

NO INTERVENTION

Stem cell therapy is not done for this group of spinal cord injury patients

Interventions

Autologous bone marrow mononuclear cell transplantationBIOLOGICAL

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

Stem cell

Eligibility Criteria

Age12 Months - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed cases of any type of spinal cord injury
  • age above 12 months.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neurogen brain and spine institute

Mumbai, Maharashtra, 400071, India

Location

Related Publications (5)

  • 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

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 20353375BACKGROUND

  • 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.

    PMID: 17600518BACKGROUND

  • 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.

    PMID: 22507683BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Alok K Sharma, MS,MCh

    Neurogen Brain and Spine Institute

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2013

First Posted

December 11, 2013

Study Start

August 1, 2012

Primary Completion

June 1, 2018

Study Completion

December 1, 2018

Last Updated

October 25, 2018

Record last verified: 2018-10

Locations

IN(1)