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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01162915
Recruitment Status : Suspended (Suspended due to lack of funding.)
First Posted : July 15, 2010
Last Update Posted : May 9, 2014
Sponsor:
Information provided by (Responsible Party):
TCA Cellular Therapy

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Spinal Cord Injury Biological: Autologous bone marrow-derived mesenchymal stem cells. Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2010
Estimated Primary Completion Date : May 2014
Estimated Study Completion Date : May 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01162915


Locations
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United States, Louisiana
TCA Cellular Therapy, LLC
Covington, Louisiana, United States, 70433
Sponsors and Collaborators
TCA Cellular Therapy
More Information
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Additional Information:

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Responsible Party: TCA Cellular Therapy
ClinicalTrials.gov Identifier: NCT01162915    
Other Study ID Numbers: 2009-SCI-I
First Posted: July 15, 2010    Key Record Dates
Last Update Posted: May 9, 2014
Last Verified: September 2013
Keywords provided by TCA Cellular Therapy:
Spinal Cord Injury
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System