Trial record 4 of 33 for:    Brachial Plexus Injuries

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Leiden University Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:
Leiden University Medical Center
ClinicalTrials.gov Identifier:
NCT00755586
First received: September 18, 2008
Last updated: August 17, 2009
Last verified: August 2009
  Purpose

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.


Condition Intervention Phase
Brachial Plexus Injury
Procedure: Mononuclear cell injection: 4 * 10e8 cells
Procedure: Mononuclear cell injection: 8 * 10e8 cells
Procedure: No mononuclear cell injection
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Autologous Bone Marrow Transplantation for Muscle Improvement in Traumatic Brachial Plexus Injuries

Resource links provided by NLM:


Further study details as provided by Leiden University Medical Center:

Primary Outcome Measures:
  • 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. [ Time Frame: Two years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. [ Time Frame: Two years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 18
Study Start Date: January 2009
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A 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.
Experimental: B 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.
No Intervention: C Procedure: No mononuclear cell injection
Patients will receive a muscle tendon transposition surgery without bone marrow aspiration or mononuclear cell injection.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00755586

Contacts
Contact: Rob GHH Nelissen, MD, PhD 0031715263606 r.g.h.h.nelissen@lumc.nl

Locations
Netherlands
Leiden University Medical Center Recruiting
Leiden, Netherlands, 2300RC
Contact: Bouke J Duijnisveld, MD, MSc    0031715263606    b.j.duijnisveld@lumc.nl   
Contact: Rob GHH Nelissen, MD, PhD    0031715263606    r.g.h.h.nelissen@lumc.nl   
Principal Investigator: Rob GHH Nelissen, MD, PhD         
Sub-Investigator: Bouke J Duijnisveld, MD, MSc         
Sponsors and Collaborators
Leiden University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
Principal Investigator: Rob GHH Nelissen, MD, PhD Leiden University Medical Center
  More Information

No publications provided

Responsible Party: Prof.dr. R.G.H.H. Nelissen, Leiden University Medical Center, department of orthopaedics
ClinicalTrials.gov Identifier: NCT00755586     History of Changes
Other Study ID Numbers: 40-41200-98-040
Study First Received: September 18, 2008
Last Updated: August 17, 2009
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Leiden University Medical Center:
Brachial plexus
Muscle denervation
Stem cell transplantation
Bone marrow cells
Satellite cells
Fibrosis

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on August 28, 2014