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

Leiden University Medical Center (LUMC)

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Brachial Plexus Injury

Treatments

Procedure: No mononuclear cell injection

Procedure: Mononuclear cell injection: 4 * 10e8 cells

Procedure: Mononuclear cell injection: 8 * 10e8 cells

Study type

Interventional

Funder types

Other

Identifiers

NCT00755586

40-41200-98-040

Details and patient eligibility

About

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.

Full 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.

Enrollment

18 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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