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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00755586
Other study ID # 40-41200-98-040
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received September 18, 2008
Last updated August 17, 2009
Start date January 2009
Est. completion date January 2011

Study information

Verified date August 2009
Source Leiden University Medical Center
Contact Rob GHH Nelissen, MD, PhD
Phone 0031715263606
Email r.g.h.h.nelissen@lumc.nl
Is FDA regulated No
Health authority Netherlands: Medical Ethics Review Committee (METC)
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Mononuclear 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.
Mononuclear 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.
No mononuclear cell injection
Patients will receive a muscle tendon transposition surgery without bone marrow aspiration or mononuclear cell injection.

Locations

Country Name City State
Netherlands Leiden University Medical Center Leiden

Sponsors (2)

Lead Sponsor Collaborator
Leiden University Medical Center ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

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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