MedTrace Logo

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

NCT00755586 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2009-08-18

No results posted yet for this study

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.

Conditions

  • Brachial Plexus Injury

Interventions

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.

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.

PROCEDURE

No mononuclear cell injection

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

Sponsors & Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • Leiden University Medical Center

    lead OTHER

Principal Investigators

  • Rob GHH Nelissen, MD, PhD · Leiden University Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • Netherlands

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00755586 on ClinicalTrials.gov