Treatment for Acute Spinal Cord Injury

Spinal Cord Injury Clinical Trial

Official title:

Clinical Study of Treatment for Acute Spinal Cord Injury Using Cultured Bone Marrow Stromal Cells

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00695149
• Other study ID #: UHA_SCI0401
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: June 9, 2008
• Last updated: June 1, 2011
• Start date: July 2005
• Est. completion date: March 2010

Study information

• Verified date: June 2011
• Source: Translational Research Informatics Center, Kobe, Hyogo, Japan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: March 2010
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 60 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Procedure:
• Transplantation of bone marrow stromal cell

Locations

Country	Name	City	State
Japan	Kansai Medical University	Moriguchi	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Translational Research Informatics Center, Kobe, Hyogo, Japan

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Ohta M, Suzuki Y, Noda T, Ejiri Y, Dezawa M, Kataoka K, Chou H, Ishikawa N, Matsumoto N, Iwashita Y, Mizuta E, Kuno S, Ide C. Bone marrow stromal cells infused into the cerebrospinal fluid promote functional recovery of the injured rat spinal cord with reduced cavity formation. Exp Neurol. 2004 Jun;187(2):266-78. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Motor function		six months	No
Secondary	Sensation		six months	Yes