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

Spinal Cord Injury Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01162915
• Other study ID #: 2009-SCI-I
• Status: Suspended
• Phase: Phase 1
• First received: July 13, 2010
• Last updated: May 7, 2014
• Start date: July 2010
• Est. completion date: May 2014

Study information

• Verified date: September 2013
• Source: TCA Cellular Therapy
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 10
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Biological:
• Autologous bone marrow-derived mesenchymal stem cells.
Intrathecal infusion of a single dose of ex vivo expanded MSC.

Locations

Country	Name	City	State
United States	TCA Cellular Therapy, LLC	Covington	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
TCA Cellular Therapy

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	Phase I trial to assess safety of intrathecal infusion of autologous mesenchymal stem cell treatment in spinal cord injury.	12 months	Yes

External Links

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