CLINIC TRIALS: Stem Cell Therapy for Patients with BPI

[Christopher]

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

[Judy-T]

All I can say is WOW!

[racerboy]

Thanks for posting this Chris. I saw this on CT.gov and on an older UBPN post. I can't participate b/c I do not meet the inclusion criteria: must be 2 yr. post-surgery. I'm only 10 weeks out. If you get enrolled, please keep us informed.


Message was edited by: racerboy

[Carolyn J]

I 2nd Judy T's WOW!!!
Chris, please keep us updated & whomever gets enrolled from our UBPN Family, OK???

Carolyn J
LOBPI adult/71

[Christopher]

Dr. Wise Young responds to viability questions about this type of procedure...
http://sci.rutgers.edu/forum/showthread ... ost1051688

[Humboldtmtnbkr]

Christopher, I was wondering if you have actually been in contact with this institution and with whom you made contact. I have emailed one of the contacts on the webpage but have gotten no response. Just wondering if you have ventured further into this as far as possibly becoming a patient. Thanks, JJ.

[Christopher]

JJ,
No I haven't tried to contact them yet, but will soon. I've been away from home and want to settle down and research a bit before I try and reach them. If you get a reply, please post about it. I'm very interested in looking into their work.

One of my significant concerns about their logic is that nerve size (number of fascicles) has a lot to do with the muscle's ability to grow and regenerate, so wouldn't an enlarged muscle still return to a smaller atrophied size as long as the supplying nerve was small? Like an intercostal (rib nerve) nerve to a transferred Gracilus to the Biceps area for elbow flexion (which is what I had done 6 years ago and what they are testing their therapy on). When you eat pork or beef ribs, you never realize you are eating intercostal nerves that are tucked in there because they are so small.

I'm sure you being an electrician can understand my concern. Limited wire gauge cannot conduct the necessary power or amperage to a large targeted motor that demands more. The motor will run at a very limited capacity, if at all, much like my arm does now. That small nerve is equivalent to putting out a fire through a soda straw instead of a fire hose.

Christopher

[Brandon_3]

I new I logged on to the boards for a reason. It's been awhile. I am going to follow up on this it looks like I meet all the requirements. Praying to the Gods of science.

[Brandon_3]

If anyone has any direct contact info that would be great.

[Humboldtmtnbkr]

Hey Christopher, thanks for the respsonse. I appreciate the electrical terminology as well, your logic seems very solid.
I did actually try to contact the doctors listed on the web page by way of email. I have not recieved any response. I am wondering if they are still even reviewing prospective patients. I don't really know if I am a candidate anyway. I am still very slowly seeing some slight advancements in my bicep/brachioradialis. I have another appointment with the Mayo on 8/26 to see if I am a candidate for a possible tendon transfer to give me curl action when my palm is facing up. I have good flextion with the palm down, so I believe they are thinking they can transfer something from the inside of my forearm up higher towards my bicep. Not sure exactly, but it seems kinda strange. I want to make sure I really need this before I actually fly there and meet with them. Anyway, sorry about the long winded message, but thanks again for your response. JJ