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

T

TCA Cellular Therapy

Status and phase

Suspended
Phase 1

Conditions

Spinal Cord Injury

Treatments

Biological: Autologous bone marrow-derived mesenchymal stem cells.

Study type

Interventional

Funder types

Industry

Identifiers

NCT01162915
2009-SCI-I

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

Safety
Experimental group
Description:
Infusion of autologous bone marrow-derived mesenchymal stem cells.
Treatment:
Biological: Autologous bone marrow-derived mesenchymal stem cells.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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