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Treatment for Acute Spinal Cord Injury

T

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Status and phase

Terminated
Phase 2
Phase 1

Conditions

Spinal Cord Injury

Treatments

Procedure: Transplantation of bone marrow stromal cell

Study type

Interventional

Funder types

Other

Identifiers

NCT00695149
UHA_SCI0401

Details and patient eligibility

About

This clinical trial aims to treat a damaged spinal cord by injecting your own bone marrow stromal cells (autologous bone marrow stromal cells) into cerebrospinal fluid through the lumbar puncture, and assess the safety and efficacy of the procedure.

Enrollment

5 patients

Sex

All

Ages

15 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Spinal cord injury is confirmed with MRI
  • Methylprednisolone therapy according to this study can be started within 8 hours after the injury
  • Bone marrow stromal cells (BMSCs) incubation can be started within 72 hours after the injury
  • Age between 15 and 60
  • With the informed consent of obtaining bone marrow and injecting incubated BMSCs.

Exclusion criteria

  • Complete disruption of spinal cord
  • Central spinal cord injury
  • Spinal canal stenosis before the injury
  • Brain or spinal cord disease before the injury
  • Positive serologic test in at least one of the following; HBs antigen, HCV antibody, HIV antibody, or HTLV-1 antibody
  • Pregnancy

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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