Clinical Trials for BPI
Posted: Tue Dec 07, 2010 11:23 pm
http://clinicaltrials.gov/ct2/show/NCT00755586
Official Title
Autologous Bone Marrow Transplantation for Muscle Improvement in Traumatic Brachial Plexus Injuries
This study is currently recruiting participants.
Verified by Leiden University Medical Center, August 2009
First Received: September 18, 2008 Last Updated: August 17, 2009
Purpose
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.
Eligibility
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:
* BP patients with paresis of m. biceps brachii (MRC 1,2,3), either after conservative treatment or at least two years after nerve surgery with partial recovery of the elbow flexor
* Patients capable and willing to give informed consent
Exclusion Criteria:
* Function recovery of the elbow flexor (m. biceps brachii) to a MRC motor scale of 0
* EMG activity: no motor unit potentials
* Medical history of other central of peripheral neurological disorders
* Inability to undergo BM harvesting
* Bleeding diathesis, INR > 2