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

Primary Purpose

Spinal Cord Injury

Status
Suspended
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Autologous bone marrow-derived mesenchymal stem cells.
Sponsored by
TCA Cellular Therapy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring Spinal Cord Injury

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • TCA Cellular Therapy, LLC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Safety

Arm Description

Infusion of autologous bone marrow-derived mesenchymal stem cells.

Outcomes

Primary Outcome Measures

Safety
Phase I trial to assess safety of intrathecal infusion of autologous mesenchymal stem cell treatment in spinal cord injury.

Secondary Outcome Measures

Full Information

First Posted
July 13, 2010
Last Updated
May 7, 2014
Sponsor
TCA Cellular Therapy
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1. Study Identification

Unique Protocol Identification Number
NCT01162915
Brief Title
Transfer of Bone Marrow Derived Stem Cells for the Treatment of Spinal Cord Injury
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 Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Suspended
Why Stopped
Suspended due to lack of funding.
Study Start Date
July 2010 (undefined)
Primary Completion Date
May 2014 (Anticipated)
Study Completion Date
May 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TCA Cellular Therapy

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
Spinal Cord Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Safety
Arm Type
Experimental
Arm Description
Infusion of autologous bone marrow-derived mesenchymal stem cells.
Intervention Type
Biological
Intervention Name(s)
Autologous bone marrow-derived mesenchymal stem cells.
Intervention Description
Intrathecal infusion of a single dose of ex vivo expanded MSC.
Primary Outcome Measure Information:
Title
Safety
Description
Phase I trial to assess safety of intrathecal infusion of autologous mesenchymal stem cell treatment in spinal cord injury.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
TCA Cellular Therapy, LLC
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.tcacellulartherapy.com
Description
Related Info

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

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