Brachial Plexus Injury
Conditions
Keywords
Brachial plexus, Muscle denervation, Stem cell transplantation, Bone marrow cells, Satellite cells, Fibrosis
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 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.
Interventions
PROCEDUREMononuclear 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.
PROCEDUREMononuclear 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.
PROCEDURENo mononuclear cell injection
Patients will receive a muscle tendon transposition surgery without bone marrow aspiration or mononuclear cell injection.
Sponsors
ZonMw: The Netherlands Organisation for Health Research and Development
Leiden University Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Netherlands
Contacts
Primary ContactRob GHH Nelissen, MD, PhD
Outcome results
None listed