Status:
UNKNOWN
Stem Cell Therapy to Improve the Muscle Function of Patients With Partly Denervated Muscles of the Arm
Lead Sponsor:
Leiden University Medical Center
Collaborating Sponsors:
ZonMw: The Netherlands Organisation for Health Research and Development
Conditions:
Brachial Plexus Injury
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2011
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00755586
Start Date
January 1 2009
End Date
January 1 2011
Last Update
August 18 2009
Active Locations (1)
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1
Leiden University Medical Center
Leiden, Netherlands, 2300RC