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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

Tracking Information
First Submitted Date  ICMJE July 13, 2010
First Posted Date  ICMJE July 15, 2010
Last Update Posted Date May 9, 2014
Study Start Date  ICMJE July 2010
Estimated Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2010)
Safety [ Time Frame: 12 months ]
Phase I trial to assess safety of intrathecal infusion of autologous mesenchymal stem cell treatment in spinal cord injury.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01162915 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transfer of Bone Marrow Derived Stem Cells for the Treatment of Spinal Cord Injury
Official Title  ICMJE 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
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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Spinal Cord Injury
Intervention  ICMJE Biological: Autologous bone marrow-derived mesenchymal stem cells.
Intrathecal infusion of a single dose of ex vivo expanded MSC.
Study Arms  ICMJE Experimental: Safety
Infusion of autologous bone marrow-derived mesenchymal stem cells.
Intervention: Biological: Autologous bone marrow-derived mesenchymal stem cells.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: July 13, 2010)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2014
Estimated Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01162915
Other Study ID Numbers  ICMJE 2009-SCI-I
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party TCA Cellular Therapy
Study Sponsor  ICMJE TCA Cellular Therapy
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account TCA Cellular Therapy
Verification Date September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP