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Autologous Bone Marrow Cell Transplantation in Persons With Acute Spinal Cord Injury- An Indian Pilot Study.

NCT02260713 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2018-03-12

No results posted yet for this study

Summary

Pilot study on 7 subjects in each group (total 21 subjects) to establish the safety and feasibility of autologous bone marrow cell transplantation in case of acute complete spinal cord injury by each of the following techniques and a corresponding number of controlled subjects:

* Directly into the injured site with a syringe after exposing the spinal cord.
* By Intrathecal injection.

Conditions

  • Acute Spinal Cord Injury

Interventions

BIOLOGICAL

autologous bone marrow cell

Transplantation of 200 million cells in 1.8 ml of autologous plasma in a single sitting. In case of intralesional route, the cells were delivered in one sitting at six sites ( 2 above the lesion, 2 at the lesion and 2 below the lesion) as 0.3 ml aliquots each. In case of Intrathecal route, the cells were delivered as a single injection of 1.8ml via lumbar puncture.

Sponsors & Collaborators

  • Indian Council of Medical Research

    collaborator OTHER_GOV

  • Indian Spinal Injuries Centre

    lead OTHER

Principal Investigators

  • Dr Harvinder S Chhabra, MS · Indian Spinal Injuries Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2017-11-30
Completion
2017-11-30

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02260713 on ClinicalTrials.gov