Stem Cell Therapy to Improve the Muscle Function of Patients With Partly Denervated Muscles of the Arm
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|ClinicalTrials.gov Identifier: NCT00755586|
Recruitment Status : Unknown
Verified August 2009 by Leiden University Medical Center.
Recruitment status was: Recruiting
First Posted : September 19, 2008
Last Update Posted : August 18, 2009
|Condition or disease||Intervention/treatment||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 (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Autologous Bone Marrow Transplantation for Muscle Improvement in Traumatic Brachial Plexus Injuries|
|Study Start Date :||January 2009|
|Estimated Primary Completion Date :||January 2011|
|Estimated Study Completion Date :||January 2011|
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.
|No Intervention: C||
Procedure: No mononuclear cell injection
Patients will receive a muscle tendon transposition surgery without bone marrow aspiration or mononuclear cell injection.
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00755586
|Contact: Rob GHH Nelissen, MD, PhDfirstname.lastname@example.org|
|Leiden University Medical Center||Recruiting|
|Leiden, Netherlands, 2300RC|
|Contact: Bouke J Duijnisveld, MD, MSc 0031715263606 email@example.com|
|Contact: Rob GHH Nelissen, MD, PhD 0031715263606 firstname.lastname@example.org|
|Principal Investigator: Rob GHH Nelissen, MD, PhD|
|Sub-Investigator: Bouke J Duijnisveld, MD, MSc|
|Principal Investigator:||Rob GHH Nelissen, MD, PhD||Leiden University Medical Center|