United Brachial Plexus Network, Inc.

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

jpixstix wrote:how do you sign up for this?

Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00755586

Contacts
Contact: Rob GHH Nelissen, MD, PhD 0031715263606 r.g.h.h.nelissen@lumc.nl

Locations
Netherlands
Leiden University Medical Center Recruiting
Leiden, Netherlands, 2300RC
Contact: Bouke J Duijnisveld, MD, MSc 0031715263606 b.j.duijnisveld@lumc.nl
Contact: Rob GHH Nelissen, MD, PhD 0031715263606 r.g.h.h.nelissen@lumc.nl
Principal Investigator: Rob GHH Nelissen, MD, PhD
Sub-Investigator: Bouke J Duijnisveld, MD, MSc
Sponsors and Collaborators
Leiden University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
Principal Investigator: Rob GHH Nelissen, MD, PhD Leiden University Medical Center
More Information

No publications provided

Responsible Party: Leiden University Medical Center, department of orthopaedics ( Prof.dr. R.G.H.H. Nelissen )
ClinicalTrials.gov Identifier: NCT00755586 History of Changes
Other Study ID Numbers: 40-41200-98-040
Study First Received: September 18, 2008
Last Updated: August 17, 2009
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Carolyn J wrote:GREAT NEWS!! Who on these TBPI BOARDS are going to partictipate? Christopher??
"Gramma" wants to know.
Carolyn J
LOBPI/72