Regenerative Medicine Research
While studies of the regenerative medicine are ongoing, there needs to be more reliable scientific studies producing empirical evidence to substantiate these regenerative properties. Most of our patients have experienced a great deal of success in alleviating pain with these therapies.
Mesenchymal Stem Cell Research
Long Term Studies
More Mesenchymal Stem Cell Published Research Abstracts
Treatment of lumbar degenerative disc disease-associated radicular pain with culture-expanded autologous mesenchymal stem cells: a pilot study on safety and efficacy.
Degenerative disc disease (DDD) is a common cause of lower back pain with radicular symptoms and has a significant socioeconomic impact given the associated disability. Limited effective conservative therapeutic options result in many turning to surgical alternatives for management, which vary in the rate of success and also carry an increased risk of morbidity and mortality associated with the procedures. Several animal based studies and a few human pilot studies have demonstrated safety and suggest efficacy in the treatment of DDD with mesenchymal stem cells (MSCs). The use of bone marrow-derived MSCs for the treatment of DDD is promising and in the present study we report on the safety and efficacy findings from a registry based proof of concept study using a percutaneous intradiscal injection of cultured MSCs for the management of DDD with associated radicular symptoms.
Thirty-three patients with lower back pain and disc degeneration with a posterior disc bulge diagnosed on magnetic resonance imaging (MRI) met the inclusion criteria and were treated with culture-expanded, autologous, bone marrow-derived MSCs. Prospective registry data was obtained at multiple time intervals up to 6 years post-treatment. Collected outcomes included numeric pain score (NPS), a modified single assessment numeric evaluation (SANE) rating, functional rating index (FRI), measurement of the intervertebral disc posterior dimension, and adverse events.
Three patients reported pain related to procedure that resolved. There were no serious adverse events (i.e. death, infection, or tumor) associated with the procedure. NPS change scores relative to baseline were significant at 3, 36, 48, 60, and 72 months post-treatment. The average modified SANE ratings showed a mean improvement of 60% at 3 years post-treatment. FRI post-treatment change score averages exceeded the minimal clinically important difference at all time points except 12 months. Twenty of the patients treated underwent post-treatment MRI and 85% had a reduction in disc bulge size, with an average reduction size of 23% post-treatment.
Patients treated with autologous cultured MSCs for lower back pain with radicular symptoms in the setting of DDD reported minor adverse events and significant improvements in pain, function, and overall subjective improvement through 6 years of follow-up.
Abstract: The use of stem cells in orthopedics has been researched for many years, with robust animal data that show efficacy in cartilage healing, tendon repair, and intervertebral disk treatment. Early clinical data are also just starting to be published, and these results are encouraging. Safety data in large case series, some that lasted for many years, have also been published. The field of tissue engineering with stem cells in musculoskeletal impairments has the potential to reduce morbidity and improve clinical outcomes. The regulatory environment for this area of medicine is still developing.
Copyright © 2014 American Academy of Physical Medicine and Rehabilitation. Published by Elsevier Inc. All rights reserved. PMID: 24439149
Regeneration of meniscus cartilage in a knee treated with percutaneously implanted autologous mesenchymal stem cells.
Centeno CJ, Busse D, Kisiday J, Keohan C, Freeman M, Karli D.
Regenerative Sciences Inc, Centeno-Schultz Clinic, Westminster, CO 80020, USA.
Mesenchymal stem cells are pluripotent cells found in multiple human tissues including bone marrow, synovial tissues, and adipose tissues. They have been shown to differentiate into bone, cartilage, muscle, and adipose tissue and represent a possible promising new therapy in regenerative medicine. Because of their multi-potent capabilities, mesenchymal stem cell (MSC) lineages have been used successfully in animal models to regenerate articular cartilage and in human models to regenerate bone. The regeneration of articular cartilage via percutaneous introduction of mesenchymal stem cells (MSC’s) is a topic of significant scientific and therapeutic interest. Current treatment for cartilage damage in osteoarthritis focuses on surgical interventions such as arthroscopic debridement, microfracture, and cartilage grafting/transplant. These procedures have proven to be less effective than hoped, are invasive, and often entail a prolonged recovery time. We hypothesize that autologous mesenchymal stem cells can be harvested from the iliac crest, expanded using the patient’s own growth factors from platelet lysate, then successfully implanted to increase cartilage volume in an adult human knee. We present a review highlighting the developments in cellular and regenerative medicine in the arena mesenchymal stem cell therapy, as well as a case of successful harvest, expansion, and transplant of autologous mesenchymal stem cells into an adult human knee that resulted in an increase in meniscal cartilage volume.
Riordan NH1,2,Â Morales I3,Â FernÃ¡ndez G4,Â Allen N5,Â Fearnot NE5,Â Leckrone ME6,Â Markovich DJ5,Â Mansfield D5,Â Avila D3,Â Patel AN7,Â Kesari S8,Â Paz Rodriguez J4.
Multiple sclerosisÂ (MS) is a progressively debilitating neurological condition in which the immune system abnormally erodes the myelin sheath insulating the nerves.Â Mesenchymal stem cellsÂ (MSC) have been used in the last decade to safely treat certain immune and inflammatory conditions.
A safety and feasibility study was completed on the use of umbilical cord MSC (UCMSC) as a treatment for MS. In this 1-year study, consenting subjects received seven intravenous infusions of 20â€‰Ã—â€‰106Â UCMSC over 7Â days. Efficacy was assessed at baseline, 1Â month and 1Â year after treatment, including magnetic resonance imaging (MRI) scans, Kurtzke Expanded Disability Status Scale (EDSS), Scripps Neurological Rating Scale, Nine-Hole Peg Test, 25-Foot Walk Test, and RAND Short Form-36 quality of life questionnaire.
Twenty subjects were enrolled in this study. No serious adverse events were reported. Of the mild AEs denoted as possibly related to treatment, most were headache or fatigue. Symptom improvements were most notable 1Â month after treatment. Improvements were seen in EDSS scores (pâ€‰<â€‰0.03), as well as in bladder, bowel, and sexual dysfunction (pâ€‰<â€‰0.01), in non-dominant hand average scores (pâ€‰<â€‰0.01), in walk times (pâ€‰<â€‰0.02) and general perspective of a positive health change and improved quality of life. MRI scans of the brain and the cervical spinal cord showed inactive lesions in 15/18 (83.3%) subjects after 1Â year.
Treatment with UCMSC intravenous infusions for subjects with MS is safe, and potential therapeutic benefits should be further investigated. Trial registration ClinicalTrials.govÂ NCT02034188. Registered Jan 13, 2014. https://clinicaltrials.gov/ct2/show/NCT02034188.
Intraperitoneal infusion of mesenchymal stem cell attenuates severity of collagen antibody induced arthritis
Nam Y, Jung SM, Rim YA, Jung H, Lee K, Park N, Kim J, Jang Y, Park YB, Park SH, Ju JH
It is unclear how systemic administration ofÂ mesenchymalÂ stemÂ cellsÂ (MSCs) controls local inflammation. The aim of this study was to evaluate the therapeutic effects of human MSCs on inflammatoryÂ arthritisÂ and to identify the underlying mechanisms. Mice with collagen antibody-inducedÂ arthritisÂ (CAIA) received two intraperitoneal injections of human bone marrow-derived MSCs. The clinical and histological features of injected CAIA were then compared with those of non-injected mice. The effect of MSCs on induction of regulatory TÂ cellsÂ was examined both in vitro and in vivo. We also examined multiple cytokines secreted by peritoneal mononuclearÂ cells, along with migration of MSCs in the presence of stromal cell-derived factor-1 alpha (SDF-1Î±) and/or regulated on activation, normal T cell expressed and secreted (RANTES). Sections of CAIA mouse joints and spleen were stained for human anti-nuclear antibodies (ANAs) to confirm migration of injected human MSCs. The results showed that MSCs alleviated the clinical and histological signs of synovitis in CAIA mice. Peritoneal lavageÂ cellsÂ from mice treated with MSCs expressed higher levels of SDF-1Î± and RANTES than those from mice not treated with MSCs. MSC migration was more prevalent in the presence of SDF-1Î± and/or RANTES. MSCs induced CD4+ TÂ cellsÂ to differentiate into regulatory TÂ cellsÂ in vitro, and expression of FOXP3 mRNA was upregulated in the forepaws of MSC-treated CAIA mice. Synovial and splenic tissues from CAIA mice receiving human MSCs were positive for human ANA, suggesting recruitment of MSCs. Taken together, these results suggest that MSCs migrate into inflamed tissues and directly induce the differentiation of CD4+ TÂ cellsÂ into regulatory TÂ cells, which then suppress inflammation. Thus, systemic administration of MSCs may be a therapeutic option forÂ rheumatoid arthritis.
Mesenchymal stromal cells-derived matrix Gla protein contribute to the alleviation of experimental colitis
Feng Y, Liao Y, Huang W, Lai X, Luo J, Du C, Lin J, Zhang Z, Qiu D, Liu Q, Shen H, Xiang AP, Zhang Q
Crohn’s disease (CD) is a chronic inflammatory bowel disease that is difficult to treat. However, previous preclinical and clinical studies have shown thatÂ mesenchymalÂ stromalÂ cellsÂ (MSCs) are a promising therapeutic approach, whereas the exact underlying molecular mechanisms of MSCs in treating CD remain unclear. Furthermore, the heterogeneity of MSCs, as well as the in vivo microenvironments may influence the therapeutic efficacy. In our previous study, we found that a subpopulation of mouse MSCs with a high expression of matrix Gla protein (MGP), one of the members of vitamin K-dependent protein family, possessed better immunoregulatory properties. Therefore, in this study we investigate whether the abundant MSCs-derived MGP participate in the therapeutic mechanisms for MSCs treating CD. Obvious suppression of cell proliferation and cytokine production in TÂ cellsÂ were observed in vitro through MSCs-derived MGP. Moreover, MGP alleviated the clinical and histopathological severity of colonicÂ inflammationÂ in mouse experimental colitis models to a remarkable degree. Our results indicate that MGP might be a novel important mediator of MSCs-mediated immunomodulation in treating CD.
Erectile Dysfunction Research Studies
Our ED Treatments are backed by dozens of clinical studies. You can read for yourself here:
- Efficiency Assessment of Shock Wave Therapy in Patients with Pelvic Pain Employing Harmonic Analysis of Penile Bioimpedance
Bulletin of Experimental Biology and Medicine, Vol. 155, No. 2, June, 2013 METHODS
- Low intensity extracorporeal shockwave therapy for erectile dysfunction: a study in an Indian population
The Canadian Journal of Urology; 22(1); February 2015
Low-intensity Extracorporeal Shock Wave Treatment Improves Erectile Function: A Systematic Review and Meta-analysis
2016 European Association of Urology. Published by Elsevier B.V.
- Our Experience on the Association of a New Physical and Medical Therapy in Patients Suffering from Induratio penis plastica
February 10, 1999 European Urology Mirone – Erectile Dysfunction
- Can Low-Intensity Extracorporeal Shockwave Therapy ImproveErectile Function? A 6-Month Follow-up Pilot Study in Patients with Organic Erectile Dysfunction
April 16, 2010 European Urology Vardi – Extracorporeal shock wave therapy
Tadalafil once daily and extracorporeal shock wave therapy in the management of patients with Peyronie’s disease and erectile dysfunction: results from a prospective randomized trial
International Journal of Andrology, 2012
- Initial experience with linear focused shockwave treatment for erectile dysfunction: a 6-month follow-up pilot study
International Journal of Impotence Research (2014)
- Impact of aging and comorbidity on the efficacy of low-intensity shock wave therapy for erectile dysfunction
International Journal of Urology (2016)
- Low-Intensity Extracorporeal Shock Wave Therapy—A Novel Effective Treatment for Erectile Dysfunction in Severe ED Patients Who Respond Poorly to PDE5 Inhibitor Therapy
2011 International Society for Sexual Medicine
Penile Low Intensity Shock Wave Treatment is Able to Shift PDE5i Nonresponders to Responders: A Double-Blind, Sham Controlled Study
The Journal of Urology® – 2016 by American Urological Assoc. Education And Research Inc.
Does Low Intensity Extracorporeal Shock Wave Therapy Have a Physiological Effect on Erectile Function? Short-Term Results of a Randomized, Double-Blind, Sham Controlled Study
The Journal of Urology® – 2016 by American Urological Assoc. Education And Research Inc.
- Therapeutic advances in the treatment of Peyronie’s disease
© 2015 American Society of Andrology and European Academy of Andrology
Evaluation of clinical efficacy, safety and patient satisfaction rate after low-intensity extracorporealshockwave therapy for the treatment of male erectile dysfunction: an Australian first open-label single-arm prospective clinical trial
2015 The Authors – BJU International © 2015 BJU International
Peyronie’s disease the Plymouth experience of extracorporeal shockwave treatment
2001 BJU International 849
Safety and efficacy of low intensity shockwave (LISW)treatment in patients with erectile dysfunction
September – October, 2015 – Department of Urology, Federico II University, Naples, Italy; 2 Department of Urology, Hospital, SantaMaria delle Grazie, Naples, Italy
Extracorporeal shockwave therapy in the treatment of erectile dysfunction: A prospective, randomized, double-blinded, placebo controlled study
International Journal of Urology (2014)
Treatment of Peyronie’s Disease by Extracorporeal Shockwave Therapy: Evaluation of Our Preliminary Results
JOURNAL OF ENDOUROLOGY – Volume 13, Number 8, October 1999 – Mary Ann Liebert, Inc.
Shockwave Therapy as First-Line Treatment for Peyronie’s Disease: A Prospective Study
JOURNAL OF ENDOUROLOGY – Volume 19, Number 1, January/February 2005
- Penile Low-Intensity Shock Wave Therapy: A Promising Novel Modality for Erectile Dysfunction
Korean Journal of Urology – The Korean Urological Association, 2014
- Peyronie’s disease and low intensity shock wave therapy: Clinical outcomes and patient satisfaction rate in an open-label single arm prospective study in Australian men
1 October, 2015 – Korean Journal of Urology – Eric Chung – AndroUrology Centre
Twelve-Month Efficacy and Safety of Low-Intensity Shockwave Therapy for Erectile Dysfunction in Patients Who Do Not Respond to Phosphodiesterase Type 5 Inhibitors
2016 International Society for Sexual Medicine
Shockwave treatment of erectile dysfunction
Therapeutic Advances in Urology-Gruenwald
- Pro: does shockwave therapy have a place in the treatment of Peyronie’s disease?
2016 Translational Andrology & Urology-Chung
- Con: does shockwave therapy have a place in the treatment of Peyronie’s disease?
2016 Department of Urology, Royal Victoria hospital, McGil University, Montreal, Québec, Canada
Low-Intensity Shock Wave Therapy and Its Application to Erectile Dysfunction
World J Mens Health 2013 December 31
Safety and efficacy of low intensity shockwave (LISW) treatment in patients with erectile dysfunction.
2016 Dr. Rob Gordon – Erectile Dysfunction & Shock Wave Therapy
Can low-intensity extracorporeal shockwavetherapy improve erectile dysfunction? A prospective, randomized, double-blind, placebocontrolled study
2014 Scandinavian Journal of Urology
Low-Intensity Extracorporeal Shock Wave Therapy in Vascular Disease and Erectile Dysfunction: Theory and Outcomes
2013 International Society for Sexual Medicine
- Is there a role for extracorporeal shock wave therapy for erectile dysfunction unresponsive to phosphodiesterase type 5 inhibitors?
Springer-Verlag Berlin Heidelberg 2016 – Urological Institute
- Low intensity shock wave therapy in men with erectile dysfunction and Peyronie’s disease: An analysis of predictors of clinical success and patient satisfaction rate based on prospective open-label single arm clinical trial.
2016 Dr. Rob Gordon – Erectile Dysfunction & Shock Wave Therapy
Platlet-Rich Plasma Research
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