Stem Cell Therapy to Improve the Muscle Function of Patients With Partly Denervated Muscles of the Arm

Phase 1

• Conditions: Brachial Plexus Injury
• Interventions: Procedure: No mononuclear cell injection

• Registration Number: NCT00755586
• Lead Sponsor: Leiden University Medical Center

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.

Study Timeline

• Study First Submitted: 2008-09-18
• Study First Submitted QC: 2008-09-18
• Study First Posted: 2008-09-19
• Study Start: 2009-01
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-17
• Last Update Posted: 2009-08-18
• Primary Completion: 2011-01
• Study Completion: 2011-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 18

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
C	No mononuclear cell injection	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Leiden University Medical Center; 🇳🇱 Leiden, Netherlands