e-Journal of Age Management Medicine | July 2010
Using autologous adult stem cells in an Age Management practice
Stem Cell Therapy: Doing It Right
Christopher J. Centeno, M.D.
The big pharma machine has been cranking out press releases through Madison Avenue PR firms this past few months, excoriating the less than perfect track records of off-shore stem cell clinics (aka the competition). Some of this criticism is fair (many of these clinics will treat any disease with a name) and some ridiculous (a recent claim that stem cells killed a woman with end stage renal disease when she actually died of sepsis due to an AV shunt infection). What is clear is that off-shore stem clinics do need to clean up their act, and as stem cell therapy rolls out into the practice of medicine in the U.S., it needs to be better implemented.
I?ve spoken to several age management physicians these past few months who are just beginning to add basic stem cell therapy to their clinics. This is mostly simple Stromal Vascular Fraction (SVF) from adipose tissue obtained through liposuction. The advice I can give them: don?t make the same mistakes as off-shore clinics. Here?s the basic list of 7 fundamental rules of the road:
Follow peer reviewed professional guidelines: The International Cellular Medicine Society (ICMS) is the only organization to date to publish real world guidelines. Get involved with ICMS at www.cellmedicinesociety.org and get your clinic ICMS certified.
Go slow and be careful: ICMS clinical guidelines require that any new stem cell type (like SVF) used to treat a new tissue type and disease first get IRB approval through an HHS registered IRB (like the ICMS IRB or similar) and then only 5-10 patients are treated over the first 6 months with careful monitoring of complications. The guidelines then allow more patients to be treated in a graded fashion with peer review of the safety. Unlike drug trials, patients can be charged during this time, but they also need to be informed that they are paying for investigational care.
Prospectively grade candidates: One of the dividing lines between off-shore stem cell clinics vs. ICMS certified clinics is providing patients with realistic expectations. Stem cells are not magic nor do they fix everything nor do stem cells always work to repair tissue. Prospective grading uses common sense dividing lines to separate good vs. poor candidates. As an example, before data is available, a rotator cuff repair application might be based on the size of the tear. As another example, for a patient with peripheral vascular disease, grading may be based on the size of the necrotic lesion. In addition, as soon as data is available, that data should be used to change the grading system to more accurately grade patients. As a real world example, in our orthopedic hip application, we recently discovered patients with hip effusions were reporting less robust outcomes than those without effusions. That data was immediately used to improve our grading system.
The therapy must be based on a successful animal model: The basic concept that stem cell type X will heal tissue Y using delivery method Z needs to be demonstrated before being used in patients. As an example, do animal models exist that show that SVF helps repair damaged lung tissue when the cells are injected intravenous? While this doesn?t necessarily need to be as nonsensical as many drug adoption roadblocks (i.e. hyaluronic acid is FDA approved for the knee, but not the hip, as if hip cartilage was somehow vastly different from knee cartilage), it does need to make sense. As another example of reasonable flexibility, if animal models demonstrate that mesenchymal stem cells have been used to repair knee cartilage when injected intra-articular, the same should hold true for cartilage in other joints. In addition, with tens of thousands of papers published on adult stem cells, many, many animals already exist, so replicating this animal research is often not necessary.
Get third party review of your lab processes: ICMS offers stem cell lab guidelines and lab certification with a third party auditor to help implement lab best practices. Other auditors are also available. Whether the lab is as simple as a biologic safety cabinet in a room or as complex as a culture expansion lab, you can always improve safety. We have had our lab inspected 5 times by outside auditors and each time the experience makes us think harder about safety.
Actively track patients through a third party registry: Stem cells are investigational and like any new therapy they require long-term active follow-up. Despite this, most off-shore clinics track their patients like any medical clinic; a nurse makes a follow-up call, but unless the patient comes back to the clinic for follow-up care, it ends there. In addition, many patients won?t travel great distances once they?ve completed their therapy for a quick follow-up in the office.
Active follow-up means that patients are contacted at specific time points and only dropped from follow-up if they fail to answer a certain number of times. In addition, short ?teaser? questionnaires need to be used to illicit a complaint. Proper complications tracking dictates that every complaint needs to be dealt with by a staff member and some will require review by a physician. Ultimately a physician needs to adjudicate complications as mild, moderate or severe and likely, possible, or unlikely to be related to the stem cell procedure. Finally, having a third party handle the details (like the ICMS registry) allows the clinic to keep an arm length from the process.
Publish your work in peer reviewed journals: Publish or perish. This isn?t just an academic credo, for physicians performing an investigational therapy, it?s critical. If you haven?t published before, then partner with someone who knows the ins and outs. This can start with simple case studies, move to case series, and then larger case series, and then finally controls. While randomized controlled trials can help determine generalizability to large populations, objective evidence of tissue repair may be equally compelling.
In summary, the nascent field of stem cell therapy will either be successfully launched as the practice of medicine or be killed by the pharma juggernaut based on execution. At a recent conference, I added to the end of my lecture, ?Don?t be a yahoo??. Said another way, ?Strive to do it right!?
Christopher J. Centeno, M.D. is a stem cell expert and founding member of the International Cellular Medicine Society. He practices image guided, percutaneous, orthopedic stem cell therapy in Denver, Colorado, where he maintains a state of the art stem cell culture expansion facility as part of his medical practice.
Using autologous adult stem cells in an Age Management practice
Stem Cell Therapy: Doing It Right
Christopher J. Centeno, M.D.
The big pharma machine has been cranking out press releases through Madison Avenue PR firms this past few months, excoriating the less than perfect track records of off-shore stem cell clinics (aka the competition). Some of this criticism is fair (many of these clinics will treat any disease with a name) and some ridiculous (a recent claim that stem cells killed a woman with end stage renal disease when she actually died of sepsis due to an AV shunt infection). What is clear is that off-shore stem clinics do need to clean up their act, and as stem cell therapy rolls out into the practice of medicine in the U.S., it needs to be better implemented.
I?ve spoken to several age management physicians these past few months who are just beginning to add basic stem cell therapy to their clinics. This is mostly simple Stromal Vascular Fraction (SVF) from adipose tissue obtained through liposuction. The advice I can give them: don?t make the same mistakes as off-shore clinics. Here?s the basic list of 7 fundamental rules of the road:
Follow peer reviewed professional guidelines: The International Cellular Medicine Society (ICMS) is the only organization to date to publish real world guidelines. Get involved with ICMS at www.cellmedicinesociety.org and get your clinic ICMS certified.
Go slow and be careful: ICMS clinical guidelines require that any new stem cell type (like SVF) used to treat a new tissue type and disease first get IRB approval through an HHS registered IRB (like the ICMS IRB or similar) and then only 5-10 patients are treated over the first 6 months with careful monitoring of complications. The guidelines then allow more patients to be treated in a graded fashion with peer review of the safety. Unlike drug trials, patients can be charged during this time, but they also need to be informed that they are paying for investigational care.
Prospectively grade candidates: One of the dividing lines between off-shore stem cell clinics vs. ICMS certified clinics is providing patients with realistic expectations. Stem cells are not magic nor do they fix everything nor do stem cells always work to repair tissue. Prospective grading uses common sense dividing lines to separate good vs. poor candidates. As an example, before data is available, a rotator cuff repair application might be based on the size of the tear. As another example, for a patient with peripheral vascular disease, grading may be based on the size of the necrotic lesion. In addition, as soon as data is available, that data should be used to change the grading system to more accurately grade patients. As a real world example, in our orthopedic hip application, we recently discovered patients with hip effusions were reporting less robust outcomes than those without effusions. That data was immediately used to improve our grading system.
The therapy must be based on a successful animal model: The basic concept that stem cell type X will heal tissue Y using delivery method Z needs to be demonstrated before being used in patients. As an example, do animal models exist that show that SVF helps repair damaged lung tissue when the cells are injected intravenous? While this doesn?t necessarily need to be as nonsensical as many drug adoption roadblocks (i.e. hyaluronic acid is FDA approved for the knee, but not the hip, as if hip cartilage was somehow vastly different from knee cartilage), it does need to make sense. As another example of reasonable flexibility, if animal models demonstrate that mesenchymal stem cells have been used to repair knee cartilage when injected intra-articular, the same should hold true for cartilage in other joints. In addition, with tens of thousands of papers published on adult stem cells, many, many animals already exist, so replicating this animal research is often not necessary.
Get third party review of your lab processes: ICMS offers stem cell lab guidelines and lab certification with a third party auditor to help implement lab best practices. Other auditors are also available. Whether the lab is as simple as a biologic safety cabinet in a room or as complex as a culture expansion lab, you can always improve safety. We have had our lab inspected 5 times by outside auditors and each time the experience makes us think harder about safety.
Actively track patients through a third party registry: Stem cells are investigational and like any new therapy they require long-term active follow-up. Despite this, most off-shore clinics track their patients like any medical clinic; a nurse makes a follow-up call, but unless the patient comes back to the clinic for follow-up care, it ends there. In addition, many patients won?t travel great distances once they?ve completed their therapy for a quick follow-up in the office.
Active follow-up means that patients are contacted at specific time points and only dropped from follow-up if they fail to answer a certain number of times. In addition, short ?teaser? questionnaires need to be used to illicit a complaint. Proper complications tracking dictates that every complaint needs to be dealt with by a staff member and some will require review by a physician. Ultimately a physician needs to adjudicate complications as mild, moderate or severe and likely, possible, or unlikely to be related to the stem cell procedure. Finally, having a third party handle the details (like the ICMS registry) allows the clinic to keep an arm length from the process.
Publish your work in peer reviewed journals: Publish or perish. This isn?t just an academic credo, for physicians performing an investigational therapy, it?s critical. If you haven?t published before, then partner with someone who knows the ins and outs. This can start with simple case studies, move to case series, and then larger case series, and then finally controls. While randomized controlled trials can help determine generalizability to large populations, objective evidence of tissue repair may be equally compelling.
In summary, the nascent field of stem cell therapy will either be successfully launched as the practice of medicine or be killed by the pharma juggernaut based on execution. At a recent conference, I added to the end of my lecture, ?Don?t be a yahoo??. Said another way, ?Strive to do it right!?
Christopher J. Centeno, M.D. is a stem cell expert and founding member of the International Cellular Medicine Society. He practices image guided, percutaneous, orthopedic stem cell therapy in Denver, Colorado, where he maintains a state of the art stem cell culture expansion facility as part of his medical practice.