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Ryan Benton Discusses Stem Cell Therapy for Duchenne’s Muscular Dystrophy – Video

By LizaAVILA


Ryan Benton Discusses Stem Cell Therapy for Duchenne #39;s Muscular Dystrophy
Ryan Benton is the first patient in the United States to receive human umbilical cord-derived mesenchymal stem cell therapy for Duchenne #39;s muscular dystrophy...

By: http://www.cellmedicine.com

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Ryan Benton Discusses Stem Cell Therapy for Duchenne's Muscular Dystrophy - Video

categoriaUncategorized commentoComments Off on Ryan Benton Discusses Stem Cell Therapy for Duchenne’s Muscular Dystrophy – Video dataFebruary 20th, 2015
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Stem Cell Therapy: Dr. Roberta Shapiro – A NY Physician’s Path to Panama – Video

By raymumme


Stem Cell Therapy: Dr. Roberta Shapiro - A NY Physician #39;s Path to Panama
Special Guest Speaker, Roberta F. Shapiro DO, FAAPM R speaks about: A New York Doctor #39;s Path to Panama at the Stem Cell Institute #39;s Stem Cell Therapy Publi...

By: http://www.cellmedicine.com

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Stem Cell Therapy: Dr. Roberta Shapiro - A NY Physician's Path to Panama - Video

categoriaUncategorized commentoComments Off on Stem Cell Therapy: Dr. Roberta Shapiro – A NY Physician’s Path to Panama – Video dataNovember 23rd, 2014
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Stem Cell Therapy for Multiple Sclerosis: Ron McGill – Video

By JoanneRUSSELL25


Stem Cell Therapy for Multiple Sclerosis: Ron McGill
Ron McGill suffers from relapsing-remitting multiple sclerosis. He was started experiencing symptoms in 2009 but was not diagnosed with MS until January of 2013. He received several infusion...

By: http://www.cellmedicine.com

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Stem Cell Therapy for Multiple Sclerosis: Ron McGill - Video

categoriaUncategorized commentoComments Off on Stem Cell Therapy for Multiple Sclerosis: Ron McGill – Video dataNovember 8th, 2014
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Stem Cell Therapy || Heart Failure || Stem Cell Treatment …

By NEVAGiles23

Heart Disease

With respect to the heart, stem cells have the ability to not only home into the damaged areas but also to initiate a cascade of biological events which both culminate in healing of the heart muscle. For example, animal studies have demonstrated that stem cell therapy will cause new muscle cells to be formed through stimulation of dormant stem cells that are already inside the heart muscle. In these studies, the administered stem cell also transformed into new heart muscle cells.

At Stem Cell Institute, our stem cell treatment protocol for heart failure involves administration of mesenchymal stem cells harvested from human umbilical cord tissue.

The adult stem cells used to treat heart failure at the Stem Cell Institute come from human umbilical cord tissue (allogeneic mesenchymal). These stem cells are expanded at Medistem Panamas state-of-the-art laboratory.

The mesenchymal stem cells we use are recovered from donated umbilical cords following normal, healthy births. Each mother has her medical history screened and is tested for infectious diseases. Proper consent is received from each family prior to donation.

All umbilical cord-derived stem cells are screened for infectious diseases to International Blood Bank Standards before they are cleared for use in patients.

Approximately 1 in 10 donated umbilical cords pass our rigorous screening process.

Through retrospective analysis of our cases, weve identified proteins and genes that allow us to screen several hundred umbilical cord donations to find the ones that we know are most effective. We only use these cells and we call them golden cells.

We go through a very high throughput screening process to find cells that we know have the best anti-inflammatory activity, the best immune modulating capacity, and the best ability to stimulate regeneration.

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Stem Cell Therapy || Heart Failure || Stem Cell Treatment ...

categoriaCardiac Stem Cells commentoComments Off on Stem Cell Therapy || Heart Failure || Stem Cell Treatment … dataNovember 3rd, 2014
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Stem Cell Therapy || Spinal Cord Injury || Investigational …

By raymumme

Spinal Cord Injury

Damage to the spinal cord usually results in impairments or loss of muscle movement, muscle control, sensation and body system control.

Presently, post-accident care for those who suffer spinal cord injuries focuses on extensive physical therapy, occupational therapy, and other rehabilitation therapies; teaching the injured person how to cope with their disability.

A number of published papers and case studies support the feasibility of treating spinal cord injury with allogeneic human umbilical cord tissue-derived stem cells and autologous bone marrow-derived stem cells.

Feasibility of combination allogeneic stem cell therapy for spinal cord injury: a case report co-authored by Stem Cell Institute Founder Dr. Neil Riordan references many of them. Published improvements include improved ASIA scores, improved bladder and/or bowel function, recovered sexual function, and increased muscle control.

The adult stem cells used in spinal cord injury investigational treatments at the Stem Cell Institute come from two sources: the subjects own bone marrow (autologous mesenchymal and CD34+) and human umbilical cord tissue (allogeneic mesenchymal).

A licensed anesthesiologist harvests bone marrow from both hips under light general anesthesia in a hospital operating room. This procedure takes about 1 1/2 2 hours. Before they are administered to the subject, these bone marrow-derived stem cells must pass testing for quality, bacterial contamination (aerobic and anaerobic) and endotoxin.

All donated umbilical cords are screened for viruses and bacteria to International Blood Bank Standards.

Our stem cell clinical protocol for spinal cord injury calls for a total of 16 injections over the course of 4 weeks.

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Stem Cell Therapy || Spinal Cord Injury || Investigational ...

categoriaSpinal Cord Stem Cells commentoComments Off on Stem Cell Therapy || Spinal Cord Injury || Investigational … dataSeptember 2nd, 2014
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Spinal cord injury and stem cell publications

By NEVAGiles23

Scientific publications from PubMed.gov

PubMed comprises more than 23 million citations for biomedical literature from MEDLINE, life science journals, and online books. Citations may include links to full-text content from PubMed Central and publisher web sites.

Regen Med. 2013 May;8(3):271-81 Authors: Ning G, Tang L, Wu Q, Li Y, Li Y, Zhang C, Feng S

Abstract AIM: We aim to explore the repair mechanism after the transplantation of CD34(+) human umbilical cord blood cells (HUCBCs) in traumatic spinal cord injury (SCI) in rats.

MATERIALS & METHODS: Wistar rats with SCI were randomly divided into three groups: DMEM injection (group A); CD34(+) HUCBC transplantation on the first day after injury (group B); and CD34(+) HUCBC transplantation on the sixth day after injury (group C). The Basso, Beattie and Bresnahan scores were used to evaluate motor behavior. At the injured site, the infarct size, blood vessel density, and survival and neural differentiation of transplanted cells were analyzed.

RESULTS: It was found that the Basso, Beattie and Bresnahan score in group B was significantly higher than other groups (p < 0.05), and the infarct size and blood vessel density at the injured site were significantly different (p < 0.01). However, the transplanted cells survived at least 3 weeks at the injured site, but did not differentiate into neural cells.

CONCLUSION: These results suggested transplantation of CD34(+) HUCBCs during the acute phase could promote the functional recovery better than during the subacute phase after SCI by raising blood vessel density, suggesting the possible clinical application for the treatment of spinal injury.

PMID: 23627822 [PubMed - indexed for MEDLINE]

Cytotherapy. 2013 Feb;15(2):185-91 Authors: Liu J, Han D, Wang Z, Xue M, Zhu L, Yan H, Zheng X, Guo Z, Wang H

Abstract BACKGROUND AIMS: The purpose of this study was to observe the clinical effect and safety of umbilical cord mesenchymal stem cells (UC-MSCs) in treating spinal cord injury (SCI) by intrathecal injection.

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Spinal cord injury and stem cell publications

categoriaSpinal Cord Stem Cells commentoComments Off on Spinal cord injury and stem cell publications dataSeptember 1st, 2014
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Stem Cell Therapy for Autism || Treatment Information …

By raymumme

Autism Protocol

Current investigative therapies for autism attempt to reverse these abnormalities through administration of antibiotics, antiinflammatory agents, and hyperbaric oxygen. Unfortunately, none of these approaches address the root causes of oxygen deprivation and intestinal inflammation.

Mesenchymal stem cells can regulate the immune system. It is thought that they may help to reverse inflammatory conditions and is currently in the final stages of clinical trials in the US for Crohns disease, a condition resembling the gut inflammation in autistic children.

Through administration of mesenchymal stem cells, we have observed improvement in subjects to whom weve administered stem cells at our facilities. The biological basis for our scientists appears in a peer-reviewed publication Journal of Translational Medicine: Stem Cell Therapy for Autism.

The adult stem cells used in the autism clinical investigation at the Stem Cell Institute come from human umbilical cord tissue (allogeneic mesenchymal). These stem cells are recovered from donated umbilical cords. Before they are approved for use, all umbilical cord-derived stem cells are screened for viruses and bacteria to International Blood Bank Standards. In some cases, we also utilize stem cells harvested from the subjects own bone marrow. Umbilical cord-derived stem cells are ideal for the autism protocol because they allow our physicians to administer uniform doses and they do not require any stem cell collection from the subject, which for autistic children and their parents, can be an arduous process. Because they are collected right after (normal) birth, umbilical cord-derived cells are much more potent than their older counterparts like bone marrow-derived cells for instance. Cord tissue-derived mesenchymal stem cells pose no rejection risk because the body does not recognize them as foreign.

Because HUCT stem cells are less mature than other cells, the bodys immune system is unable to recognize them as foreign and therefore they are not rejected. Weve performed thousands of procedures with umbilical cord stem cells and there has never been a single instance of rejection. HUCT stem cells also proliferate/differentiate more efficiently than older cells, such as those found in the bone marrow and therefore, they are considered to be more potent.

The umbilical cord-derived stem cells are administered intravenously by a licensed physician.

Below is an example of a typical autism schedule. Our investigational clinical protocol for autism (www.clinicaltrials.gov NCT02192749) has been approved by the National Institutional Review Board for Clinical Protocols.

Proper follow-up is an essential part of the autism clinical investigation process. Our primary goal is to ensure that your child is progressing safely. Regular follow-up also enables us to evaluate efficacy and improve our autism clinical protocols based on observed outcomes.

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Stem Cell Therapy for Autism || Treatment Information ...

categoriaUncategorized commentoComments Off on Stem Cell Therapy for Autism || Treatment Information … dataJuly 24th, 2014
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TRAGIC STORY! Paid $25,000 for Stem Cells @ Hospital Angeles Tijuana www.RegenerativeMedicine.mx – Video

By daniellenierenberg


TRAGIC STORY! Paid $25,000 for Stem Cells @ Hospital Angeles Tijuana http://www.RegenerativeMedicine.mx
TWO Websites: http://www.regenerativemedicinemx.com AND http://www.regenerativemedicinetijuana.com STEM CELL Resources: http://www.cellmedicinesociety.org/component/content/article/86-news/410-mex...

By: KyaLarae

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TRAGIC STORY! Paid $25,000 for Stem Cells @ Hospital Angeles Tijuana http://www.RegenerativeMedicine.mx - Video

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Stem Cell Therapy || Spinal Cord Injury Treatment || Stem …

By Dr. Matthew Watson

Spinal Cord Injury

Damage to the spinal cord usually results in impairments or loss of muscle movement, muscle control, sensation and body system control.

Presently, post-accident care for spinal cord injury patients focuses on extensive physical therapy, occupational therapy, and other rehabilitation therapies; teaching the injured person how to cope with their disability.

A number of published papers and case studies support the feasibility of treating spinal cord injury with allogeneic human umbilical cord tissue-derived stem cells and autologous bone marrow-derived stem cells.

Feasibility of combination allogeneic stem cell therapy for spinal cord injury: a case report co-authored by Stem Cell Institute Founder Dr. Neil Riordan references many of them. Published improvements include improved ASIA scores, improved bladder and/or bowel function, recovered sexual function, and increased muscle control.

The adult stem cells used to treat spinal cord injuries at the Stem Cell Institute come from two sources: the patients own bone marrow (autologous mesenchymal and CD34+) and human umbilical cord tissue(allogeneic mesenchymal).

A licensed anesthesiologist harvests bone marrow from both hips under light general anesthesia in a hospital operating room. This procedure takes about 1 1/2 2 hours. Before they are administered to the patient, these bone marrow-derived stem cells must pass testing for quality, bacterial contamination (aerobic and anaerobic) and endotoxin.

All donated umbilical cords are screened for viruses and bacteria to International Blood Bank Standards.

Our stem cell treatment protocol for spinal cord injury calls for a total of 16 injections over the course of 4 weeks.

Originally posted here:
Stem Cell Therapy || Spinal Cord Injury Treatment || Stem ...

categoriaSpinal Cord Stem Cells commentoComments Off on Stem Cell Therapy || Spinal Cord Injury Treatment || Stem … dataApril 22nd, 2014
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Sam Harrell’s Stem Cell Journey: Stem Cell Therapy for Multiple Sclerosis – Video

By LizaAVILA


Sam Harrell #39;s Stem Cell Journey: Stem Cell Therapy for Multiple Sclerosis
Sam Harrell sent us this homemade video documenting his progress from 2010 until now (2014). Sam was coaching football at Ennis high school in Texas when MS ...

By: http://www.cellmedicine.com

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Sam Harrell's Stem Cell Journey: Stem Cell Therapy for Multiple Sclerosis - Video

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Stem Cell Therapy for Spinal Cord Injury: Jamie Richie discusses her improvements – Video

By daniellenierenberg


Stem Cell Therapy for Spinal Cord Injury: Jamie Richie discusses her improvements
Jamie Richie discussed her treatments and improvements while undergoing her third round of stem cell therapy at the Stem Cell Institute in Panama City, Panam...

By: http://www.cellmedicine.com

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Stem Cell Therapy for Spinal Cord Injury: Jamie Richie discusses her improvements - Video

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ICMS International Cell Medicine Society

By Dr. Matthew Watson

T he International Cellular Medicine Society (ICMS) is an international non-profit dedicated to patient safety through strict evaluation of protocols and rigorous oversight of clinics and facilities engaged in the translation of point-of-care cell-based treatments.As a Professional Medical Association, the ICMS represents Physiciansand Researchersfrom over 35 countries who share a mission to provide Scientifically Credible and Medically Appropriate Treatments to Informed Patients.Join the ICMS.

The ICMS Works Tirelessly for the Clincial Translation of Field of Cell-Based Point-of-Care Treatments through:

Comprehensive Medical Standards and Best Practice Guidelines for Cell Based Medicine,

Strict Evaluation and Rigerous Oversight of Stem Cell Clinics and Facilities through aGlobal Accreditation Process,

Physician Education through daily updates on the latest Research on Stem Cells, the monthly Currents In Stem Cell Medicine and the annual International Congress for Regenerative and Stem Cell Medicine.

Join the ICMSto receive the latest news and research from cell-based medicne, including the bi-monthly publication, Currents in Stem Cell Medicine.

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ICMS International Cell Medicine Society

categoriaUncategorized commentoComments Off on ICMS International Cell Medicine Society dataJanuary 9th, 2014
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Stem Cell Therapy for Traumatic Brain Injury – Video

By raymumme


Stem Cell Therapy for Traumatic Brain Injury
Oswaldo Tapenes received multiple injections of human umbilical cord-derived mesenchymal stem cells and his own bone marrow-derived stem cells over the cours...

By: http://www.cellmedicine.com

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Stem Cell Therapy for Traumatic Brain Injury - Video

categoriaUncategorized commentoComments Off on Stem Cell Therapy for Traumatic Brain Injury – Video dataDecember 16th, 2013
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Heart Failure Patient Has 3 Normal EKGs After Stem Cell Therapy – Video

By raymumme


Heart Failure Patient Has 3 Normal EKGs After Stem Cell Therapy
I was diagnosed 20 years ago. My heart was stopped up. I have 11 stents in my heart. When they put in (stents) nine, ten and eleven they blocked an artery an...

By: http://www.cellmedicine.com

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Heart Failure Patient Has 3 Normal EKGs After Stem Cell Therapy - Video

categoriaUncategorized commentoComments Off on Heart Failure Patient Has 3 Normal EKGs After Stem Cell Therapy – Video dataDecember 11th, 2013
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Stem Cells | ICMS — Advancing Stem Cell Treatments, Stem Cell …

By LizaAVILA

T he International Cellular Medicine Society (ICMS) is an international non-profit dedicated to patient safety through strict evaluation of protocols and rigorous oversight of clinics and facilities engaged in the translation of point-of-care cell-based treatments.As a Professional Medical Association, the ICMS represents Physiciansand Researchersfrom over 35 countries who share a mission to provide Scientifically Credible and Medically Appropriate Treatments to Informed Patients.Join the ICMS.

The ICMS Works Tirelessly for the Clincial Translation of Field of Cell-Based Point-of-Care Treatments through:

Comprehensive Medical Standards and Best Practice Guidelines for Cell Based Medicine,

Strict Evaluation and Rigerous Oversight of Stem Cell Clinics and Facilities through aGlobal Accreditation Process,

Physician Education through daily updates on the latest Research on Stem Cells, the monthly Currents In Stem Cell Medicine and the annual International Congress for Regenerative and Stem Cell Medicine.

Join the ICMSto receive the latest news and research from cell-based medicne, including the bi-monthly publication, Currents in Stem Cell Medicine.

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Stem Cells | ICMS -- Advancing Stem Cell Treatments, Stem Cell ...

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Professor Arnold Caplan discusses mesenchymal stem cell therapy for multiple sclerosis – Video

By Sykes24Tracey


Professor Arnold Caplan discusses mesenchymal stem cell therapy for multiple sclerosis
Professor Caplan is "The father of the mesenchymal stem cell (MSC)". In this clip, he describes a mouse experiment using human MSCs in a mouse model of MS. T...

By: http://www.cellmedicine.com

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Professor Arnold Caplan discusses mesenchymal stem cell therapy for multiple sclerosis - Video

categoriaUncategorized commentoComments Off on Professor Arnold Caplan discusses mesenchymal stem cell therapy for multiple sclerosis – Video dataSeptember 30th, 2013
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Stem Cell Therapy for Knees, Osteoarthritis and Autoimmune Disorders: King Goff Discusses Treatment – Video

By Sykes24Tracey


Stem Cell Therapy for Knees, Osteoarthritis and Autoimmune Disorders: King Goff Discusses Treatment
King Goff received three applications of his own adipose tissue-derived stem cells over the course of 3 days for a knee injury and autoimmune issues at the S...

By: cellmedicine

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Stem Cell Therapy for Knees, Osteoarthritis and Autoimmune Disorders: King Goff Discusses Treatment - Video

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Jorge Paz MD: Adult Stem Cell Therapy for Arthritis, Sports Injury, and Autoimmune Disease || 3 of 3 – Video

By LizaAVILA


Jorge Paz MD: Adult Stem Cell Therapy for Arthritis, Sports Injury, and Autoimmune Disease || 3 of 3
Stem cell therapy for osteoarthritis using adipose (fat) stem cell. Case study of 76 year-old man with osteoarthritis in his knees. Stromal vasular fraction treatment statistics including side effects collected over 800 infusions. Stem cell treatments for sports injuries and why pro sports stars are seeking treatment. Case study of a professional dancer with knee and neck problems who returned to competition after stem cell treatment in Panama.

By: cellmedicine

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Jorge Paz MD: Adult Stem Cell Therapy for Arthritis, Sports Injury, and Autoimmune Disease || 3 of 3 - Video

categoriaUncategorized commentoComments Off on Jorge Paz MD: Adult Stem Cell Therapy for Arthritis, Sports Injury, and Autoimmune Disease || 3 of 3 – Video dataJanuary 10th, 2013
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A proposed 6-step platform for the cell therapy industry to consider in combating non-compliant cell therapy treatments

By Dr. Matthew Watson

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Further to my recent post, "Six steps to fighting non-compliant cell therapy treatments. The stuff of grey shades, spades, ivory towers and (ahem) balls.", I have crafted a 6-point platform that I propose to submit (with potential edits based on preliminary feedback) to several of the leading  industry and professional organizations for their consideration including ARM, ISCT, ISSCR, FACTAABB  ICMS, and perhaps, in due course, to patient groups, physician groups, disease-specific professional organizations (e.g, cardiology, oncology, neurology, cosmetic, etc).



I welcome comments and feedback. 


1. In addition to helping patients distinguish between compliant and non-compliant treatments (and providers) we must do more to help patients distinguish between non-compliant cell therapy treatments (and providers) which are more or less risky. 


2. Whatever we do in response to this issue should be done with an eye to being practical and helpful to patients in the real-life context of their decision about whether or not to buy a non-complaint cell therapy.


3. Our response to this issue should be based on a risk-based approach recognizing that not all non-compliance is created equal.  We should create a framework for risk-based analysis (both for us and our audiences) and focus initiatives around those which present the highest risk.


4. We recognize the problem of non-compliant cell therapies is not just a problem that exists in jurisdictions with little, no, or poor regulation but that is a growing problem even in the most highly regulated jurisdictions meaning the solution cannot be regulated it depends on education and enforcement.


5. We recognize regulatory agencies cannot enforce non-compliance on their own.  We as an industry need to complement their efforts through our own standards and enforcement.


6. Stakeholder groups should support the formation of a multi-organizational  initiative to, based on a risk-based assessment, spotlight the categories or signs of highest-risk offenders for use by patients and/or their physicians in identifying  whether or not treatments (and providers) they may be considering fall into the that category associated with the highest level of risk.


What do you think?

Source:
http://feedproxy.google.com/~r/CellTherapyBlog/~3/wkSMxAV9938/a-proposed-6-step-platform-for-cell.html

categoriaRegenerative Medicine commentoComments Off on A proposed 6-step platform for the cell therapy industry to consider in combating non-compliant cell therapy treatments dataDecember 16th, 2012
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Six steps to fighting non-compliant cell therapy treatments. — The stuff of grey shades, spades, ivory towers and (ahem) balls.

By Dr. Matthew Watson



Today an article entitled "Professors Critique Stem Cell Medical Tourism" appeared in the online version of The Harvard Crimson summarizing a recent panel discussion hosted in least in part by Harvard Law School assistant professor I. Glenn Cohen and University of Alberta law professor Timothy Caulfield.  The article concludes thusly:

The panelists emphasized that more accurate information should be provided to the public regarding stem cell treatments.

Certainly what Cohen and Caulfield concluded is true.  It has now been true for several years.  We keep saying it.  But are we listening to ourselves?  Are we doing anything meaningful to address this?  If so, is it enough?

Sadly (in my opinion, of course) the answer is 'not nearly enough'.*

For several years now, experts and organizations in the cell therapy sector have been saying that more must be done to educate and assist patients who are seeking stem cell or other cell-based treatments which do not comply with existing regulation and/or widely accepted medical or clinical research practices (hereafter called "non-compliant cell therapies").  
In my opinion, attempts to address this need by the sector's professional organizations, while important, have been unnecessarily feeble, not gone nearly far enough, and legitimately appear by many to be high-minded and pedantic. 



Almost all efforts to-date to address this issue by ISSCR, CIRM, ISCT and others including authors such as Caufield - as laudable and needed as they are - have been focused on helping distinguish between compliant and non-compliant treatments (and providers).  This is certainly much needed.  But what is left, I submit, is an even greater unmet need.


What almost all efforts to-date have failed to recognize or address is that where real help is needed is in helping patients distinguish between the many shades of grey among non-compliant treatments (and providers).

Emerging organizations like ICMS (now in partnership with AABB) have recognized and attempted to address this unmet need through a commitment to create some level of certification, accreditation or standardization of clinics participating in this business of selling non-compliant cell therapies.

While their intentions appear on-target as one meaningful way to address this unmet need and certainly their willingness to tackle this issue in a bold way is to be lauded, the ICMS is inexperienced and underfunded.  I remain hopeful that now through their new partnership with AABB they will be able to provide something that really addresses this unmet need but the jury remains out on whether they will succeed.
Anyone who has followed this blog and/or my threads on LinkedIn know I have been thinking about and discussing this issue for some time. In a desire to move to very concrete suggestions, I want to recommend the following 6 steps to my industry colleagues and professional organizations:

1.  50 shades of grey. Let's admit that this issue is not black-and-white but, as is almost always, involves a broad spectrum of grey in the middle.  


In addition to helping patients distinguish between compliant and non-compliant treatments (and providers) there are a lot of ways to help patients distinguish between non-compliant cell therapy  treatments (and providers) which are more or less risky.  


Let me use examples.  

On the one end of the non-compliant spectrum I would put forward a clinical like Okyanos Heart Institute which (as I understand it) intends to provide cell therapy treatments in the Bahamas to US patients using the Cytori system for cardiac conditions as soon as such treatments are perfectly legal and available to European patients but years before such treatments will be available in the US.  
Non-compliant?  Yes.  But certainly no evidence I'm aware of to support a belief that seeking treatment from them would be any more risky than travelling to Europe to receive the same treatment in a manner perfectly compliant with European regulations.
On the other end of the spectrum are the kinds of clinics highlighted recently by 60 minutes or which are the subject of ongoing lawsuits.

In between - in my opinion - are clinics like Stem Cell Institute and StemCellMD.

2.  Step out of the ivory tower.  Let's recognize that in certain circumstances patients are going to go pay for non-compliant cell therapies and we must do more to help these patients than simply shake our finger and tell them they mustn't.
For some, helping patients distinguish between the better and worst non-compliant clinics might involve a fair amount of nose-pinching but this is the equivalent of the methadone clinic for heroine addicts.  By supporting the better of two evils we are not endorsing it as 'good', we are simply recognizing it is better.

This is a recognition that we cannot just abandon people because they made (or are going to make) decisions with which we ultimately disapprove.   It is a recognition that sometimes the most righteous thing to do is not only to help people do what we would ideally want them to do but to help them do the best they can in their circumstances and on their terms - even terms with which we may ultimately disagree.


3.  A risk-based strategy.  Let's recognize that even the FDA triages their response to non-compliance and we would do well to do the same.  As a regulated industry we are perfectly comfortable with risk-based assessments and it should be applied here.  
Rather than treating all non-compliance as equally evil, let's apply some risk-based analysis to the situation and develop a strategy to root out the worst (highest-risk) offenders.  
4.  This is not just about tourism anymore - the problem has come home to roost. Let's recognize that this is no longer just a problem of patients leaving a regulated jurisdiction seeking a non-compliant treatment in a jurisdiction with no or more permissive regulation.  
Non-compliant treatments are growing rapidly even in the most highly regulated jurisdictions.  No where is this more true than in the United States.
5. Take responsibility.  Let's recognize that we cannot expect our regulatory enforcement agencies to do it all.  They are under-staffed and under-funded.  They - and the people we all serve - need our active participation in dealing with offenders and those risking patient safety.  
From a self-interested perspective, we owe it to our industry to help crack down on those who put the credibility and legitimacy of cell therapies at highest risk.
6.  Let's grow a pair and call a spade a spade.  If a non-compliant clinic is providing treatments that we believe represent a high-risk to patient safety and the industry's credibility, let's have the b*lls to call them on it.  They can't sue everyone.  
ISSCR backed down on their stem cell tourism initiative after being threatened by lawsuits. Who has stepped up in their absence?  Individual bloggers and authors like Paul Knoeplfer, Alexey Bresenev, Leigh Turner, and myself all who have been threatened with litigation several times for having the audacity to call certain non-compliant clinics out for what we deem - in our own risk-based analysis - to be the worst offenders.  

By way of example, several of my colleagues have recently committed to doing all they can do to call out David Steenblock and his non-compliant cell therapy treatments, many of which are provided at his clinic in California for a plethora of conditions.  In their opinion, many of his treatments represent some of worst examples of non-compliance in the United States right now.  There are many faces or fronts to his practice including http://www.davidsteenblock.comhttp://www.stemcellmd.org, http://www.strokedoctor.com, http://www.davidsteenblock.net, etc.

If, as an industry, we act with more cohesion (collaboratively applying a risk-based assessment of non-compliant clinics) and speak with a more cohesive voice in terms of calling out those clinics and treatments which we conclude pose the greatest risk based on an objective set of criterion, this will present a multi-pronged, formidable and existential threat to clinics that they can't ignore or threaten away.
___

I will be taking these 6 recommendations to any organization who will listen.  I hope you will consider doing the same.



In the meantime - as always - I welcome your comments.


___

* This is my opinion not necessarily the opinion of any clients I represent or organizations I serve. Judge me - not them - accordingly.


Source:
http://feedproxy.google.com/~r/CellTherapyBlog/~3/2b8Ffw4b1pU/six-steps-to-fighting-non-compliant.html

categoriaRegenerative Medicine commentoComments Off on Six steps to fighting non-compliant cell therapy treatments. — The stuff of grey shades, spades, ivory towers and (ahem) balls. dataDecember 2nd, 2012
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