Neil Riordan PhD – on opening a stem cell clinic in the United States

Stem Cell Pioneers featured Dr. Riordan in its February installment of “Ask the Doctor”, a monthly segment that features stem cell scientists and doctors answering questions from readers about stem cell therapy.

Over the next several days, we will share these questions and Dr. Riordan’s answers with our readers.

Question for Dr. Riordan: If the FDA loosens regulations in the U.S., do you have any plans to open a clinic here?

Dr. Riordan’s Answer: Unfortunately I don’t see FDA loosening regulations any time soon so I have no plans to do anything in the U.S. using umbilical cord MSCs or even autologous SVF in the near future.

It would be great if the U.S. would follow Japan’s lead. The Japanese parliament passed legislation in November of last year that essentially allows a company to market a cell product after the product has been demonstrated to be safe. Quoting from an Athersys press release: “Recently, Japan’s parliament enacted new legislation to promote the safe and accelerated development of treatments using stem cells. The new regenerative medicine law and revised pharmaceutical affairs law define products containing stem cells as regenerative medicine products and allow for the conditional approval of such products if safety has been confirmed in clinical trials, even if their efficacy has not been fully demonstrated.”

So you can guess where everyone is running to and isn’t the U.S. Here are press releases from Mesoblast and Athersys, respectively:


http://globenewswire.com/news-release/2013/11/25/592037/10059311/en/New-Japanese-Regenerative-Medicine-Legislation-and-Commercial-Opportunities-for-Stem-Cell-Products.html

http://finance.yahoo.com/news/athersys-announces-patents-japan-stem-120000430.html

Regarding plans for the U.S., I have thankfully partnered with Dr. Wade McKenna, who is Board Certified in Orthopedic surgery and Fellowship trained in Trauma and Trauma Reconstructive Surgery. Dr. McKenna has more experience using bone marrow concentrate for orthopedic conditions that anyone I know. We are opening a regenerative orthopedic center in the Dallas area hopefully by mid-April of this year. It will be in a new building and is being built out now. The center is called the Riordan McKenna Institute. It is located in Southlake, Texas, which is between Dallas and Ft. Worth, very near DFW airport.

Neil Riordan PhD on stem cell expansion in stem cell therapy

Stem Cell Pioneers featured Dr. Riordan in its February installment of “Ask the Doctor”, a monthly segment that features stem cell scientists and doctors answering questions from readers about stem cell therapy.

Over the next several days, we will share these questions and Dr. Riordan’s answers with our readers.

Question: Are there some conditions such as neurological ones that respond better when the cells are greatly expanded? Is a high quantity essential for success or is that something that may be more of a selling point at some clinics? I have also seen this advertised for COPD and other conditions. It’s almost like the more cells the better, but I would like your opinion.

Dr. Riordan’s Answer: That really depends on the quality of the cells after expansion. If they are still robust, not senescent, and still have a good secretion profile, then the more the better may be useful up to a point. If you take a small pool of starter cells and expand them to exhaustion, then I don’t think you are going to have a very good product. The MSCs used in Panama are not expanded beyond passage 5—a point at which there is no senescence in the population and they have a robust cytokine secretion profile. In order to use only cells that meet our release criteria, cells from approximately one (1.2 to be exact) out of 10 donated umbilical cords are used.

Contrast that to cells from a patient’s own fat tissue that are expanded. Firstly, the starting cells may, and many times are not very robust—they secrete little or no beneficial cytokines or chemokines, and must be expanded to hilt in order to hit the cell number. Please see my answer to number 7 for more on this subject.

This brings up a slightly different, yet related topic. There has been a lot of talk at recent meetings about more defined endpoints for the cells being used, and I couldn’t agree more. There are MSCs from bone marrow, menstrual blood, fat tissue, umbilical cord (even different parts of the umbilical cord—around the blood vessels, from the Wharton’s jelly, from the subepithelium, from the cord blood itself—which are most likely contaminants from a bruised placenta rather than the blood), teeth, amniotic membrane, amniotic fluid just to name sources in the “we didn’t mess with mother nature” adult stem cell world. Add to that the infinite variables when you consider the age and physical condition of the donor, particularly when using adipose or bone marrow as a source material and we, as a field, could be saying almost anything by using the term, “mesenchymal stem cell.” I think it is time that there is standardization in the field beyond the current definition of expressing/not expressing certain surface markers and the ability to differentiate into fat, bone, and cartilage. That standardization could come from using endpoints such as “remaining proliferative capacity (the number of doublings achievable in culture from the treatment cell bank), the secretome, even if there is standardization of one or two molecules, such as HGF, or one of the prostaglandins.

In the future I believe the field will take it a step further by measuring, even by a surrogate marker, the potential effects of the cells on the target condition. In the case of autoimmunity the cells and their secretions could be tested for their capacity to modulate the immune system. In the case of inflammatory conditions, the cells and their secretions could be tested for the ability to control or block inflammation.

Autologous Cell Therapies Do Not Represent a Public Health Risk and Should Not Be Regulated Like Drugs

SevOne Founder and Stem Cell Institute patient, Michael Phelan discusses what’s financially at stake for scientists, universities, drug companies, and the FDA who oppose autologous stem cell therapy and lobby for patients’ own stem cells to be regulated as drugs.

VIEW FULL ARTICLE

Forbes interview with Michael Phelan from Feb 2013: One Man’s Reluctant Tour for Adult Stem Cells by John Farrell

Excerpt:

“I chose the Stem Cell Institute because they published their research in Translational Medicine. In addition, I corresponded with physicians and researchers experienced in Autologous Stem Cell treatments, including Roger Nocera, author of Healing Cells – Cells that heal us from cradle to grave, and I also listened to Arnold Caplan of Case Western.

So, at a Johns Hopkins managed hospital in Panama I had a mini-liposuction procedure. From my adipose-fat tissue they separated and expanded my cells, which took about a week then they gave to me in an IV.

I had visual problems for over a year before treatment, including double vision. After my first treatment in May of 2012, my vision problems resolved and I was able to continue driving. My mental and physical energy improved dramatically. A number of other problems improved. So, I was pleased with the outcome.”

Medistem Panama Awarded ISO 9001 International Global Certification

Medistem Panama ISO 9001-2008 Logo

Awarded this:

CERTIFICATION

for the Quality Management System of:

MEDISTEM PANAMA

Offices included in the scope:

Ciudad del Saber, Edificio # 221, piso # 2,
Clayton, Ancón
Panama City, Republic of Panama

IAF ENAC Logos

The scope includes the following activities:

  • Isolation of stem cells from adipose tissue(ADSC) and mononuclear cells from bone marrow.
  • Expansion and harvest of mesenchymal stem cells from umbilical cord, adipose tissue and its derivatives.

ISO 9001:2008

Valid from 19, June 2016
Granted from Panama 20, June 2013

Antonio Martin
Director

IGC10126

IGC10126

VIDEO – The Science of Mesenchymal Stem Cells and Regenerative Medicine – Arnold Caplan PhD (Part 6)

In part 6, Prof. Caplan discusses Trophic properties of mesenchymal stem cells; MSCs for heart disease; MSCs homing to heart injury site and also to skin incision site; MSCs limit left ventricular thinning following infarction; Trophic properties of MSCs: anti-apoptotic, anti-fibrotic, anti-scarring, angiogenic, mitotic; phase 1 data for allogeneic MSCs show fewer arrhythmias, prompt heart rate recovery, and improved lung function; autologous adipose tissue-derived stromal vascular fraction for treatment of chronic heart disease; Active mesenchymal stem cell clinical trials around the world; Induction therapy with autologous MSCs in kidney transplants; MSCs can coax neural stem cells to become oligodendrocytes, curing mice with MS using allogeneic human MSCs.

The Science of Mesenchymal Stem Cells and Regenerative Medicine – Arnold Caplan PhD (VIDEO Part 3)

In part 3, Professor Caplan discusses the science behind mesenchymal stem cells: sources of mesenchymal stem cells (MSCs), because all MSCs are pericytes one can find them in any tissue that has blood vessels, pericytes express markers of MSCs, frequency of pericytes in human tissue, most abundant source of pericytes is adipose (fat) tissue, adipose-derived stem cells, how MSCs are separated from fat, chemistries MSCs from different tissues are not the same, MSCs function at sites of injury, mesenchymal stem cell homing in mice, MSCs don’t make fat, they don’t make muscle. They come back as pericytes, and not all pericytes are MSCs.

Arnold Caplan and Riccardo Calafiore inside Medistem Panama stem cell laboratory

Arnold Caplan and Riccardo Calafiore in Medistem Panama Lab

Arnold Caplan PhD and Riccardo Calafiore

Prof. Arnold Caplan of Case Western Reserve University and Prof. Riccardo Calafiore of the University of Perugia, Italy inside our stem cell lab. Prof. Caplan and Prof. Calafiore toured one of our three clean rooms and viewed stem cells during their visit.

They were speaking in Panama City, Panama at “La Medicina Del Futuro En El Presente”, an event organized by the honarable Ruben Berrocal MD, Minister of Science, Technology and Innovation SENACYT (National Secretariat of Science, Technology and Innovation) and Prof. K. S. Jagannatha Rao, Ph.D., FNASc, FABAP, FASB, FLS (Reino Unido) Director INDICASAT-AIP (Instituto de Investigaciones Cientificas y Servicios de Alta Tecnologia – Institute for Scientific Research and High Technology Services).

Arnold Caplan PhD of Case Western Reserve University and Riccardo Calafiore of Perugia University in Italy tour Medistem stem cell lab in Panama

Arnold Caplan PhD, Neil Riordan PhD and Riccardo Calafiore MD at Medistem Labs Panama

Arnold Caplan PhD, Neil Riordan PhD and Riccardo Calafiore MD at Medistem Labs Panama

Professor Arnold Caplan (left) and Professor Riccardo Calafiore (right) pose with Medistem Labs Panama Founder, Neil Riordan, PhD. Dr. Riordan is also the Founder of Stem Cell Institute in Panama City, Panama.

Prof. Caplan and Prof. Calafiore were in Panama City with Amit Patel MD to speak at “La Medicina Del Futuro En El Presente”, an event organized by the honarable Ruben Berrocal MD, Minister of Science, Technology and Innovation SENACYT (National Secretariat of Science, Technology and Innovation) and Prof. K. S. Jagannatha Rao, Ph.D., FNASc, FABAP, FASB, FLS (Reino Unido) Director INDICASAT-AIP (Instituto de Investigaciones Cientificas y Servicios de Alta Tecnologia – Institute for Scientific Research and High Technology Services).

Prof. Caplan is a Professor of Biology and General Medical Sciences (oncology) at Case Western Reserve University and the Director of the Skeletal Research Center at Case Western Reserve. Prof. Caplan is widely regarded as “The father of the mesenchymal stem cell”.

Prof. Calafiore is the Head of the Division of Endocrinology and Metabolism at the Medical School at the University of Perugia, Italy and Director of the Interdisciplinary Laboratory for Endocrine and Organ Transplant at the University of Perugia School of Medicine. He is also a director at ALTuCELL.

Amit Patel, MD, MS, is an associate professor in the Division of Cardiothoracic Surgery at the University of Utah School of Medicine and Director of Clinical Regenerative Medicine and Tissue Engineering at the University of Utah

Neil Riordan PhD is Founder of Stem Cell Institute in Panama City, Panama and the President of Medistem Panama. He is also CEO of Aidan Products.

Multiple Sclerosis Radio – “Stem cells are your body’s natural healing mechanism” – Neil Riordan PhD

For anyone who missed Dr. Riordan’s talk on MS Radio yesterday, below is a link to the replay. Did you know that by age 30, 96% of the mesenchymal stem cells are gone from a person’s bone marrow? Why is MS a disease of the immune system? How can an automated machine analyze a sample of lecithin and buffer that contains no cells and show that it contains 10 million cells per ml? Tune in for these and more.

REPLAY: “Stem cells are your body’s natural healing mechanism” – Neil Riordan PhD

TODAY ON MULTIPLE SCLEROSIS RADIO!
Dr. Neil Riordan, Founder of Stem Cell Institute
Tuesday Feb 5, 2013 at 2 pm EST.

LISTEN ONLINE: Multiple Sclerosis Radio

or call in Join Us LIVE On Air
(347) 327-9317
or Toll-Free
(877) 497-9936

http://www.blogtalkradio.com/msradio/2013/02/05/stem-cells-your-bodys-natural-healing-mechanism-stem-kine-1

Liposuction method can adversely affect adipose tissue-derived stem cell yield and growth

Adipose tissue-derived mesenchymal stem cell yield and growth characteristics are affected by the tissue-harvesting procedure which was published in Cytotherapy (vol. 8 issue 2, 2006, pages 166-177)states that:

“Ultrasound-assisted liposuction resulted in a lower frequency of proliferating adult stem cells, as well as a longer population doubling time of adult stem cells, compared with resection…”

Those seeking adipose stem cell therapy should ask their doctor if he or she is using ultrasound assisted liposuction to collect the fat sample.

*Stem Cell Institute does not use ultrasound assisted liposuction.

Adipose tissue-derived mesenchymal stem cell yield and growth characteristics are affected by the tissue-harvesting procedure
M.J. Oedayrajsingh-Varma1, S.M. van Ham2, M. Knippenberg3, M.N. Helder4, J. Klein-Nulend3, T.E. Schouten5, M.J.P.F. Ritt1, F.J. van Milligen, PhD5,

1 Department of Plastic Reconstructive and Hand Surgery, VU University Medical Center, Amsterdam, the Netherlands
2 Department of Immunopathology, Sanquin Research at CLB, Amsterdam, the Netherlands
3 Department of Oral Cell Biology, ACTA-Vrije Universiteit, Amsterdam, the Netherlands
4 Department of Orthopaedic Surgery, VU University Medical Center, Amsterdam, the Netherlands
5 Department of Pathology, VU University Medical Center, Amsterdam, the Netherlands
http://dx.doi.org/10.1080/14653240600621125, How to Cite or Link Using DOI
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