Stem Cell Therapy to Improve the Muscle Function of Patients With Partly Denervated Muscles of the Arm
Autologous Bone Marrow Transplantation for Muscle Improvement in Traumatic Brachial Plexus Injuries
1 other identifier
interventional
18
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jan 2009
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2008
CompletedFirst Posted
Study publicly available on registry
September 19, 2008
CompletedStudy Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedAugust 18, 2009
August 1, 2009
2 years
September 18, 2008
August 17, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Two years
Secondary Outcomes (1)
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.
Two years
Study Arms (3)
A
EXPERIMENTALB
EXPERIMENTALC
NO INTERVENTIONInterventions
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.
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.
Patients will receive a muscle tendon transposition surgery without bone marrow aspiration or mononuclear cell injection.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Leiden University Medical Center
Leiden, 2300RC, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rob GHH Nelissen, MD, PhD
Leiden University Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 18, 2008
First Posted
September 19, 2008
Study Start
January 1, 2009
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
August 18, 2009
Record last verified: 2009-08