CLINIC TRIALS: Stem Cell Therapy for Patients with BPI
-
Christopher
- Posts: 845
- Joined: Wed Jun 18, 2003 10:09 pm
- Injury Description, Date, extent, surgical intervention etc: Date of Injury: 12/15/02
Level of Injury:
-dominant side C5, C6, & C7 avulsed. C8 & T1 stretched & crushed
BPI Related Surgeries:
-2 Intercostal nerves grafted to Biceps muscle,
-Free-Gracilis muscle transfer to Biceps Region innervated with 2 Intercostal nerves grafts.
-2 Sural nerves harvested from both Calves for nerve grafting.
-Partial Ulnar nerve grafted to Long Triceps.
-Uninjured C7 Hemi-Contralateral cross-over to Deltoid muscle.
-Wrist flexor tendon transfer to middle, ring, & pinky finger extensors.
Surgical medical facility:
Brachial Plexus Clinic at The Mayo Clinic, Rochester MN
(all surgeries successful)
"Do what you can, with what you have, where you are."
~Theodore Roosevelt - Location: Los Angeles, California USA
CLINIC TRIALS: Stem Cell Therapy for Patients with BPI
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
=================================================
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
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Judy-T
- Posts: 557
- Joined: Fri Nov 02, 2001 11:59 am
- Injury Description, Date, extent, surgical intervention etc: Right arm OBPI One surgery at age 40 Ulnar nerve retransposition
- Location: Florida
Re: CLINIC TRIALS: Stem Cell Therapy for Patients with BPI
All I can say is WOW!
Re: CLINIC TRIALS: Stem Cell Therapy for Patients with BPI
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
Message was edited by: racerboy
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Carolyn J
- Posts: 3424
- Joined: Tue Apr 06, 2004 1:22 pm
- Injury Description, Date, extent, surgical intervention etc: LOBPI. I am 77 yrs old and never had a name for my injuries until 2004 when I found UBPN at age 66.
My injuries are: LOBPI on upper body and Cerebrael Palsy on the lower left extremities. The only intervention I've had is a tendon transplant from my left leg to my left foot to enable flexing t age 24 in 1962. Before that, my foot would freeze without notice on the side when wearing heels AND I always did wear them at work "to fit in" I also stuttered until around age 18-19...just outgrew it...no therapy for it. Also suffered from very very low self esteem; severe Depression and Anxiety attacks started at menopause. I stuffed emotions and over-compensated in every thing I did to "fit in" and be "invisible". My injuries were Never addressed or talked about until age 66. I am a late bloomer!!!!!
I welcome any and all questions about "My Journey".
There is NO SUCH THING AS A DUMB QUESTION.
Sharing helps to Heal. HUGS do too. - Location: Tacoma WA
- Contact:
Re: CLINIC TRIALS: Stem Cell Therapy for Patients with BPI
I 2nd Judy T's WOW!!!
Chris, please keep us updated & whomever gets enrolled from our UBPN Family, OK???
Carolyn J
LOBPI adult/71
Chris, please keep us updated & whomever gets enrolled from our UBPN Family, OK???
Carolyn J
LOBPI adult/71
Carolyn J
Adult LOBPI
Adult LOBPI
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Christopher
- Posts: 845
- Joined: Wed Jun 18, 2003 10:09 pm
- Injury Description, Date, extent, surgical intervention etc: Date of Injury: 12/15/02
Level of Injury:
-dominant side C5, C6, & C7 avulsed. C8 & T1 stretched & crushed
BPI Related Surgeries:
-2 Intercostal nerves grafted to Biceps muscle,
-Free-Gracilis muscle transfer to Biceps Region innervated with 2 Intercostal nerves grafts.
-2 Sural nerves harvested from both Calves for nerve grafting.
-Partial Ulnar nerve grafted to Long Triceps.
-Uninjured C7 Hemi-Contralateral cross-over to Deltoid muscle.
-Wrist flexor tendon transfer to middle, ring, & pinky finger extensors.
Surgical medical facility:
Brachial Plexus Clinic at The Mayo Clinic, Rochester MN
(all surgeries successful)
"Do what you can, with what you have, where you are."
~Theodore Roosevelt - Location: Los Angeles, California USA
Re: CLINIC TRIALS: Stem Cell Therapy for Patients with BPI
Dr. Wise Young responds to viability questions about this type of procedure...
http://sci.rutgers.edu/forum/showthread ... ost1051688
http://sci.rutgers.edu/forum/showthread ... ost1051688
-
Humboldtmtnbkr
- Posts: 55
- Joined: Fri Oct 24, 2008 12:23 am
- Injury Description, Date, extent, surgical intervention etc: Road cycling accident 8/31/08 stretched c5/c6. 2 1/2 years post accident now and I have regained all function and alot of strength back. I am a very lucky person.
- Location: Eureka, Ca.
Re: CLINIC TRIALS: Stem Cell Therapy for Patients with BPI
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
- Posts: 845
- Joined: Wed Jun 18, 2003 10:09 pm
- Injury Description, Date, extent, surgical intervention etc: Date of Injury: 12/15/02
Level of Injury:
-dominant side C5, C6, & C7 avulsed. C8 & T1 stretched & crushed
BPI Related Surgeries:
-2 Intercostal nerves grafted to Biceps muscle,
-Free-Gracilis muscle transfer to Biceps Region innervated with 2 Intercostal nerves grafts.
-2 Sural nerves harvested from both Calves for nerve grafting.
-Partial Ulnar nerve grafted to Long Triceps.
-Uninjured C7 Hemi-Contralateral cross-over to Deltoid muscle.
-Wrist flexor tendon transfer to middle, ring, & pinky finger extensors.
Surgical medical facility:
Brachial Plexus Clinic at The Mayo Clinic, Rochester MN
(all surgeries successful)
"Do what you can, with what you have, where you are."
~Theodore Roosevelt - Location: Los Angeles, California USA
Re: CLINIC TRIALS: Stem Cell Therapy for Patients with BPI
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
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
Re: CLINIC TRIALS: Stem Cell Therapy for Patients with BPI
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.
Re: CLINIC TRIALS: Stem Cell Therapy for Patients with BPI
If anyone has any direct contact info that would be great.
-
Humboldtmtnbkr
- Posts: 55
- Joined: Fri Oct 24, 2008 12:23 am
- Injury Description, Date, extent, surgical intervention etc: Road cycling accident 8/31/08 stretched c5/c6. 2 1/2 years post accident now and I have regained all function and alot of strength back. I am a very lucky person.
- Location: Eureka, Ca.
Re: CLINIC TRIALS: Stem Cell Therapy for Patients with BPI
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
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
