Official Title
Autologous Bone Marrow Transplantation for Muscle Improvement in Traumatic Brachial Plexus Injuries
This study is currently recruiting participants.
Verified by Leiden University Medical Center, August 2009
First Received: September 18, 2008 Last Updated: August 17, 2009
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.
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
Clinical Trials for 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
Clinical Trials for BPI
http://clinicaltrials.gov/ct2/show/NCT00755586
-
Football BPI Mom
- Posts: 10
- Joined: Fri Dec 17, 2010 4:51 am
- Injury Description, Date, extent, surgical intervention etc: My son had a football injury Nov. 20, 2010.
Re: Clinical Trials for BPI
Thank you for your Mayo link. We have sent medical records and are waiting to see if he will be accepted. Are you going to participate in this clinical trial?
-
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: Clinical Trials for BPI
GREAT NEWS!! Who on these TBPI BOARDS are going to partictipate? Christopher??
"Gramma" wants to know.
Carolyn J
LOBPI/72
"Gramma" wants to know.
Carolyn J
LOBPI/72
-
jpixstix
- Posts: 34
- Joined: Thu Apr 20, 2006 2:56 pm
- Injury Description, Date, extent, surgical intervention etc: TBPI Feb 12, 2006 Right arm dominat affected. Quad accident. Hit by snowmobile. Don't remember much. Multiple broken bones in arm , severed arteries , head injury.
- Location: Philadelphia
Re: Clinical Trials for BPI
how do you sign up for this?
-
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: Clinical Trials for BPI
read the link posted above for startersjpixstix wrote:how do you sign up for this?
http://clinicaltrials.gov/ct2/show/NCT00755586
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 )
ClinicalTrials.gov Identifier: NCT00755586 History of Changes
Other Study ID Numbers: 40-41200-98-040
Study First Received: September 18, 2008
Last Updated: August 17, 2009
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
-
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: Clinical Trials for BPI
If there still doing it in a year, I'll think about it. I'll be riding to Argentina for the next 8 months
Carolyn J wrote:GREAT NEWS!! Who on these TBPI BOARDS are going to partictipate? Christopher??
"Gramma" wants to know.
Carolyn J
LOBPI/72
-
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: Clinical Trials for BPI
Christopher, Have a SAFE and WONDERFUL trip to Argentina. 
Good Luck to everyone who is participating in this important Study.You all are terrific!
HUgs all around readers and Posters,
"Gramma" Carolyn J
LOBPI/72
Good Luck to everyone who is participating in this important Study.You all are terrific!
HUgs all around readers and Posters,
"Gramma" Carolyn J
LOBPI/72
-
MW
- Posts: 81
- Joined: Fri Jun 19, 2009 6:13 pm
- Injury Description, Date, extent, surgical intervention etc: LTBPI, Feb 2009, hit by truck while on a run. Free muscle transfer at Mayo Clinic 6 months later.
- Location: Chicago, IL
Re: Clinical Trials for BPI
I just want to make sure I'm reading this right -- this study is for muscle regeneration for long term BPI patients right? It is not for regeneration of nerve control of the affected arm, just trying to get more muscle on what you've got, correct? Sounds like a great study and I'm glad research is moving in the right direction for us.
MW
MW