Brachial Plexus Injury Clinical Trial
Official title:
Autologous Bone Marrow Transplantation for Muscle Improvement in Traumatic Brachial Plexus Injuries
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.
Status | Recruiting |
Enrollment | 18 |
Est. completion date | January 2011 |
Est. primary completion date | January 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Netherlands | Leiden University Medical Center | Leiden |
Lead Sponsor | Collaborator |
---|---|
Leiden University Medical Center | ZonMw: The Netherlands Organisation for Health Research and Development |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To assess muscle improvement, muscle biopsies, quantitative needle EMGs, muscle density analysis, force measurement, range of motion of the elbow joint and quality of life questionnaires will be performed. | Two years | Yes | |
Secondary | The secondary research aim of this study is to assess vital signs and to detect signs of hematoma and/or injection at the bone marrow aspiration site, injection site and/or surgical wound. | Two years | Yes |
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