Transfer of Bone Marrow Derived Stem Cells for the Treatment of Spinal Cord Injury - Full Text View

Sponsor:	TCA Cellular Therapy
Information provided by:	TCA Cellular Therapy
ClinicalTrials.gov Identifier:	NCT01162915

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:

MedlinePlus related topics: Spinal Cord Injuries

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:

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 May 23, 2012