CLINIC TRIALS: Stem Cell Therapy for Patients with BPI
Posted: Mon Jun 01, 2009 2:38 am
This is the first active clinical trail that I'm aware of in the 6+ years since my injury. That in its self is a great thing! The focus of this trial is not a cure for the injury, but an attempt to activate muscle regeneration via adult stem cells derived from the patients own bone marrow.
What is interesting about this trial is that they are looking to perform a free muscle transfer (I assume it would be from the upper thigh area, the gracilus muscle) to the biceps area, and they will use that muscle to test the viability of their stem cell injections. This could be good for people that have limited biceps function (as one of the entry requirement is that subjects have some kind of biceps flexion registering) and are looking for more function... for free.
I want to thank Troy from Australia for leading me to this! I've been following this stuff for a long time now, and I find this very exciting, but I'm not so sure about the actual procedure and it's probabilities. I look into it more. Thanks Troy!!!
Cheers,
Christopher
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http://clinicaltrials.gov/ct2/show/NCT0 ... 586&rank=1
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Stem Cell Therapy to Improve the Muscle Function of Patients With Partly Denervated Muscles of the Arm
This study is currently recruiting participants.
Verified by Leiden University Medical Center, January 2009
First Received: September 18, 2008 Last Updated: January 2, 2009 History of Changes
Sponsors and Collaborators: Leiden University Medical Center : The Netherlands Organisation for Health Research and Development
Information provided by: Leiden University Medical Center
ClinicalTrials.gov Identifier: NCT00755586
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
Brachial Plexus Injury
Intervention
Phase I
Procedure: Mononuclear cell injection: 4 * 10e8 cells
Phase II
Procedure: Mononuclear cell injection: 8 * 10e8 cells
Procedure: No mononuclear cell injection
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Autologous Bone Marrow Transplantation for Muscle Improvement in Traumatic Brachial Plexus Injuries
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)
A: Experimental
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.
B: Experimental
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.
C: No Intervention
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
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: Leiden University Medical Center, department of orthopaedics ( Prof.dr. R.G.H.H. Nelissen )
Study ID Numbers: 40-41200-98-040
Study First Received: September 18, 2008
Last Updated: January 2, 2009
ClinicalTrials.gov Identifier: NCT00755586 History of Changes
Health Authority: Netherlands: committee medical ethics of the LUMC
Keywords provided by Leiden University Medical Center:
Brachial plexus
Muscle denervation
Stem cell transplantation
Bone marrow cells
Satellite cells
Fibrosis
Study placed in the following topic categories:
Fibrosis
Anesthetics
ClinicalTrials.gov processed this record on May 29, 2009
What is interesting about this trial is that they are looking to perform a free muscle transfer (I assume it would be from the upper thigh area, the gracilus muscle) to the biceps area, and they will use that muscle to test the viability of their stem cell injections. This could be good for people that have limited biceps function (as one of the entry requirement is that subjects have some kind of biceps flexion registering) and are looking for more function... for free.
I want to thank Troy from Australia for leading me to this! I've been following this stuff for a long time now, and I find this very exciting, but I'm not so sure about the actual procedure and it's probabilities. I look into it more. Thanks Troy!!!
Cheers,
Christopher
=================================================
http://clinicaltrials.gov/ct2/show/NCT0 ... 586&rank=1
=================================================
Stem Cell Therapy to Improve the Muscle Function of Patients With Partly Denervated Muscles of the Arm
This study is currently recruiting participants.
Verified by Leiden University Medical Center, January 2009
First Received: September 18, 2008 Last Updated: January 2, 2009 History of Changes
Sponsors and Collaborators: Leiden University Medical Center : The Netherlands Organisation for Health Research and Development
Information provided by: Leiden University Medical Center
ClinicalTrials.gov Identifier: NCT00755586
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
Brachial Plexus Injury
Intervention
Phase I
Procedure: Mononuclear cell injection: 4 * 10e8 cells
Phase II
Procedure: Mononuclear cell injection: 8 * 10e8 cells
Procedure: No mononuclear cell injection
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Autologous Bone Marrow Transplantation for Muscle Improvement in Traumatic Brachial Plexus Injuries
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)
A: Experimental
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.
B: Experimental
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.
C: No Intervention
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
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: Leiden University Medical Center, department of orthopaedics ( Prof.dr. R.G.H.H. Nelissen )
Study ID Numbers: 40-41200-98-040
Study First Received: September 18, 2008
Last Updated: January 2, 2009
ClinicalTrials.gov Identifier: NCT00755586 History of Changes
Health Authority: Netherlands: committee medical ethics of the LUMC
Keywords provided by Leiden University Medical Center:
Brachial plexus
Muscle denervation
Stem cell transplantation
Bone marrow cells
Satellite cells
Fibrosis
Study placed in the following topic categories:
Fibrosis
Anesthetics
ClinicalTrials.gov processed this record on May 29, 2009
