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

NCT ID: NCT00755586

Last Updated: 2009-08-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2011-01-31

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.

Conditions

Brachial Plexus Injury

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

Group Type: EXPERIMENTAL

Mononuclear cell injection: 4 * 10e8 cells

Intervention Type: PROCEDURE

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.

B

Group Type: EXPERIMENTAL

Mononuclear cell injection: 8 * 10e8 cells

Intervention Type: PROCEDURE

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.

C

Group Type: NO_INTERVENTION

No mononuclear cell injection

Intervention Type: PROCEDURE

Patients will receive a muscle tendon transposition surgery without bone marrow aspiration or mononuclear cell injection.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

No mononuclear cell injection

Patients will receive a muscle tendon transposition surgery without bone marrow aspiration or mononuclear cell injection.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role: collaborator

Leiden University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Leiden University Medical Center, department of orthopaedics

Principal Investigators

Rob GHH Nelissen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Leiden University Medical Center

Locations

Leiden University Medical Center

Leiden, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Rob GHH Nelissen, MD, PhD

Role: CONTACT

r.g.h.h.nelissen@lumc.nl

0031715263606

Facility Contacts

Bouke J Duijnisveld, MD, MSc

Role: primary

b.j.duijnisveld@lumc.nl

0031715263606

Rob GHH Nelissen, MD, PhD

Role: backup

r.g.h.h.nelissen@lumc.nl

0031715263606

Other Identifiers

40-41200-98-040

Identifier Type: -

Identifier Source: org_study_id