NCT00755586

Stem Cell Therapy to Improve the Muscle Function of Patients With Partly Denervated Muscles of the Arm

Autologous Bone Marrow Transplantation for Muscle Improvement in Traumatic Brachial Plexus Injuries

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Leiden University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess muscle improvement after stem cell injection in the biceps muscle of patients with a brachial plexus injury.

Detailed description

Brachial plexus injuries can cause severe disabilities and often affect young adults and newborn children. When initial conservative treatment or nerve surgery fails, muscle/tendon transfers are the only current treatment options available to regain a functional arm. During this extensive surgery a healthy donor muscle is transposed to exert a different function. After long-term denervation the muscle is irreversibly changed. Muscle atrophy, fattening, fibrosis, decrease in capillary to muscle fiber ratio and decline in the number of satellite cells, which are responsible for post-natal muscle repair, is seen. For neuromuscular diseases, cell therapy aiming at rescuing muscle damage by delivery of cells that can differentiate into skeletal muscle, might be a promising approach. Safety questions remain whether stem cell injection results in non-muscle tissue formation like inflammatory cells or connective tissue formation in the transplanted muscles. Furthermore, it remains to be determined whether these stem cells undergo functional integration and enhance muscle function. The objective of this pilot study is to assess functional and morphological improvement of the m. biceps brachii after autologous bone marrow-derived mononuclear cell injection.

Conditions

• Brachial Plexus Injury

Interventions

Type	Name	Description
PROCEDURE	Mononuclear cell injection: 4 * 10e8 cells	350 ml bone marrow will be aspirated from the posterior iliac crest under general anesthesia in combination with a muscle tendon transposition surgery. Next, the patients will receive a bone marrow derived mononuclear cell injection of 4 \* 10e8 cells in the m. biceps brachii.
PROCEDURE	Mononuclear cell injection: 8 * 10e8 cells	650 ml bone marrow will be aspirated from the posterior iliac crest under general anesthesia in combination with a muscle tendon transposition surgery. Next, the patients will receive a bone marrow derived mononuclear cell injection of 8 \* 10e8 cells in the m. biceps brachii.
PROCEDURE	No mononuclear cell injection	Patients will receive a muscle tendon transposition surgery without bone marrow aspiration or mononuclear cell injection.

Timeline

• Start date: 2009-01-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2008-09-19
• Last updated: 2009-08-18

Locations

1 site across 1 country: Netherlands