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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by TCA Cellular Therapy.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
TCA Cellular Therapy
ClinicalTrials.gov Identifier:
NCT01162915
First received: July 13, 2010
Last updated: April 27, 2011
Last verified: April 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Spinal Cord Injury
 Biological: autologous mesenchymal stem cells
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by TCA Cellular Therapy:

Primary Outcome Measures:
  • Safety [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Phase I trial to assess safety of intrathecal infusion of autologous mesenchymal stem cell treatment in spinal cord injury.


Estimated Enrollment: 10
Study Start Date: July 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: autologous mesenchymal stem cells
    Intrathecal infusion of a single dose of ex vivo expanded MSC
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01162915

Locations
United States, Louisiana
TCA Cellular Therapy, LLC
Covington, Louisiana, United States, 70433
Sponsors and Collaborators
TCA Cellular Therapy
Investigators
Principal Investigator: Gabriel P Lasala, MD TCA Cellular Therapy, LLC
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Gabriel P. Lasala, MD, TCA Cellular Therapy, LLC
ClinicalTrials.gov Identifier: NCT01162915     History of Changes
Other Study ID Numbers: 2009-SCI-I
Study First Received: July 13, 2010
Last Updated: April 27, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by TCA Cellular Therapy:
Spinal Cord Injury

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
 Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on June 17, 2013