Transfer of Bone Marrow Derived Stem Cells for the Treatment of Spinal Cord Injury

May 7, 2014 updated by: TCA Cellular Therapy

Phase I, Single Center, Trial to Asses Safety and Tolerability of the Intrathecal Infusion of Ex-vivo Expanded Bone-marrow Derived Mesenchymal Stem Cells for the Treatment of Spinal Cord Injury

This study is based on preclinical (animal) studies showing that infusing bone marrow-derived mesenchymal stem cells into the spinal fluid may contribute to improving neurologic function in animal models with spinal cord injuries. Bone marrow (BM) contains several types of stem cells that can produce functional cells. This includes cells that could help the healing process of damaged neurologic tissue.

The primary objective of this study is to see if the injection of these cells, obtained from your own bone marrow, is safe. A secondary objective is to evaluate if the treatment can provide functional improvements (neuromuscular control and sensation) in the affected areas.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

A Phase I, single-center trial to assess the safety and tolerability of an intrathecal infusion (lumbar puncture) of autologous, ex vivo expanded bone marrow-derived mesenchymal stem cells in a well-defined population of spinal cord injury patients.

Safety will be evaluated by neurological and non-neurological tests performed after short-term (1 to 30 days) and long-term (2 to 12 months)follow-up evaluation periods after cell infusion.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • TCA Cellular Therapy, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 to 65
  • American Spinal Injury Association Impairment Scale A
  • Clinical evidence of lesions located below c-spine 5 (C-5)
  • Confirmation by MRI of injury level
  • Time between injury and enrollment greater than 2 weeks
  • Ability to provide informed consent
  • Platelet count greater than 100 Thousand/uL at screening
  • INR equal to or less than 1.5
  • Hematocrit less than 30% prior to bone marrow aspiration
  • Spinal cord injury within 60 months of screening

Exclusion Criteria:

  • Anoxic brain injury
  • Inability to provide consent
  • Sepsis
  • Neurological deficits attributed to lesions above C-5
  • Cerebro-vascular accidents with intracranial hemorrhage, acute brain injuries, meningitis, hydrocephalus or other potential diseases where the pressure in the cerebro spinal fluid is increased
  • Multiple sclerosis
  • Amyotrophic lateral sclerosis
  • Cerebral Palsy
  • Evidence of cancer over the last 3 years prior to enrollment
  • Immunosuppressive diseases
  • Platelet count lower than 100,000
  • White blood count greater than 15,000 unless the patient is on steroids
  • Bleeding disorders
  • Clinical or laboratory evidence of meningitis
  • Skin infection at the infusion site
  • Pregnant or planning to become pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Safety
Infusion of autologous bone marrow-derived mesenchymal stem cells.
Biological: Autologous bone marrow-derived mesenchymal stem cells.
Intrathecal infusion of a single dose of ex vivo expanded MSC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: 12 months
Phase I trial to assess safety of intrathecal infusion of autologous mesenchymal stem cell treatment in spinal cord injury.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TCA Cellular Therapy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (ANTICIPATED)

May 1, 2014

Study Completion (ANTICIPATED)

May 1, 2014

Study Registration Dates

First Submitted

July 13, 2010

First Submitted That Met QC Criteria

July 13, 2010

First Posted (ESTIMATE)

July 15, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

May 9, 2014

Last Update Submitted That Met QC Criteria

May 7, 2014

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-SCI-I

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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