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

NCT01162915 | Suspended Phase 1 DMC

• 1 other identifier: 2009-SCI-I
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury

Keywords

Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

• Safety

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

  12 months

Study Arms (1)

Safety

EXPERIMENTAL

Infusion of autologous bone marrow-derived mesenchymal stem cells.

Biological: Autologous bone marrow-derived mesenchymal stem cells.

Interventions

Autologous bone marrow-derived mesenchymal stem cells. BIOLOGICAL

Intrathecal infusion of a single dose of ex vivo expanded MSC.

Safety

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• TCA Cellular Therapy: lead

Study Sites (1)

TCA Cellular Therapy, LLC

Covington, Louisiana, 70433, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2010
• First Posted: July 15, 2010
• Study Start: July 1, 2010
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: May 9, 2014

Record last verified: 2013-09

Locations

US (1)