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

Tracking Information

First Received Date ^ICMJE

July 13, 2010

Last Updated Date

April 27, 2011

Start Date ^ICMJE

July 2010

Estimated Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

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 Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Phase 1

Study Design ^ICMJE

Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Spinal Cord Injury

Intervention ^ICMJE

Biological: autologous mesenchymal stem cells

Intrathecal infusion of a single dose of ex vivo expanded MSC

Study Arm (s)

Not Provided

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

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2012

Estimated Primary Completion Date

March 2012 (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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01162915

Other Study ID Numbers ^ICMJE

2009-SCI-I

Has Data Monitoring Committee

Responsible Party

Gabriel P. Lasala, MD, TCA Cellular Therapy, LLC

Study Sponsor ^ICMJE

TCA Cellular Therapy

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Gabriel P Lasala, MD

TCA Cellular Therapy, LLC

Information Provided By

TCA Cellular Therapy

Verification Date

April 2011

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

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