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.

Stem Cell Therapy for Relapsing-Remitting MS

Bonnie, who suffers from relapsing-remitting multiple sclerosis (MS) received a combination of human umbilical cord mesenchymal stem cells and adipose-derived cells administered daily over the course of 5 days.

Just wanted to send an update as I am really excited! I received my very first stem cells on 10/22/13, it has been less then a month and I am happy to report that I have tons more energy by balance is improving every day, I have no more foot drop and not even a healing I was looking for but I put my glasses on the other day only to find they made my vision blurry I didn’t need them, I am already saving for my next treatment! I can’t thank you all enough as I feel like I have a future with my 5 small children now, if you ever need someone to talk to future patients I would be happy to scream my praises! Looking forward to more and more improvement!

Sincerely,
Bonnie Barrington

For more information about MS clinical investigations at the Stem Cell Insitute: Stem Cell Therapy for Multiple Sclerosis

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.

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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Patients beware: “Point of care” fat stem cell separation and counting kits inaccurate and not US FDA approved for humans.

An informative paper by Mary Pat Moyer, PhD detailing why “same-day” fat stem cell kits that are becoming more common in doctors’ offices across the US can miscount “stem cells” by large factors leading to over estimation of stem cell counts by as much as 20 times or more.

It also states, “no complete harvest and cell isolation systems have been approved by the FDA for autologous SVF harvest for immediate use [in humans].” These are just a couple of the arguments presented that demonstrate why it’s important to process adipose tissue properly in a professional lab setting.

Morrison DG, Hunt DA, Garza I, Johnson RA, Moyer MP*. Counting and Processing Methods Impact Accuracy of Adipose Stem Cell Doses. BioProcess J, 2012; 11(4): 4-17.

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.

Stem cell therapy for rheumatoid arthritis: Darnell Morris

I have had Rheumatoid Arthritis for thirty years. I have pain and swelling in all my joints. I have had my left knee replaced also three knuckles in my right hand. I have been on numerous medications for years. None of these proved to be much help. I was not going to take any of the drugs that knockout the immune system. So I was looking for something else when a good friend of mine went to the Stem Cell Institute for treatment of MS. The result was wonderful for him. So I applied and went to Panama City, Panama and had the treatments. We got home on a Tuesday and by Monday I could raise both arms over my head. I have not been able to do this in two years. I also have experienced a feeling of relief in my body. I think this is because the pain level is so much lower after my treatment. I look forward to the year ahead for my continued improvement. I am so thankful I went. My experience was very comfortable and made simple by the planning and preparations of the doctors and their staff.

“I could raise both arms over my head. I have not been able to do this in two years. I also have experienced a feeling of relief in my body. I think this is because the pain level is so much lower after my treatment.”

Update: April, 2011

Good morning,

I am doing quite well . At times, my hands and feet get sore and tender. This is not anywhere close to what it was before. I am thinking of coming back sometime in the future for another treatment. I think that would resolve that problem. Overall, my life has improved tremendously.

When I first came down with rheumatoid arthritis, I had a really big attack . All of my major joints were inflamed , swollen, and painful. At first, my doctors didn’t give me a diagnosis. After this initial onset, the symptoms settled down to my knees, ankles, and hands. This was the way it was for a good many years . Then my feet became involved.

My condition was debilitating. I couldn’t get out of a chair without a struggle or the aid of someone else. Standing was painful due to my feet and knees. Of course the pain, swelling, & inflammation were always present.

Since my stem cell treatment, I can get out of a chair without even thinking; normally and pain free. I am able to raise my arms over my head. I haven’t been able to do that for 5 years. In general, I can say that all my movements are fluid and more normal that they were before treatment .

My quality of life has improved so much.

I went for my Well Woman’s exam and told them about my GREAT improvements. My doctor was impressed and was glad I went; no bias. I still had a high Sed Rate. That was about four months ago. I feel this high rate is due to my hands and feet still having some problems.

However, after my doctor watched me move and walk around , and checked my joints for tenderness, she could see that I had improved.

I would like to say that I was greatly impressed with the doctors, staff and clinic in Panama. Everything was so thought-out. I had no worries because so much preparation had been done for the patients. I was impressed by such cleanliness both in the hospital and the clinic. The staff was so warm and friendly. The doctors were very patient-oriented and clear while explaining the treatments; no language barrier. Panama is such a beautiful country . We loved the history and the people. We just enjoyed our stay.

I have recommended this treatment to others many, many times. I speak to people very often about stem cell treatment and I never miss the opportunity to express how much this has changed my life. Let’s just say that I stay ready to inform people about these treatments!

I am so very thankful for the research that has been done for people. I was looking at being in a wheelchair in the future. Now, I am looking forward to yard work , showing my longhorn cattle, and vacationing with my husband. Enjoying life before was just a dream and now I can truly enjoy each day. Keep up the research. If I can be of any help I am your servant.

Thank You,

Darnell Morris

Stem cell therapy for rheumatoid arthritis: Bryan Gamez

Bryan-Gamez Stem Cells Rheumatoid Arthritis Patient

Bryan Gamez – Stem Cell Recipient and Rheumatoid Arthritis Subject

I have been asked to speak about the treatment and my experience with people in my community.

I was diagnosed with RA at the age of 23 and received the the therapy at the age of 25.

I was working out at the gym 3 times per week until my ankle started hurting. Eventually, I had to stop all activity involving my ankle.

In the morning, I suffered from stiffness and limited flexibility in my joints: wrist, fingers, ankles, knees and hip. My fingers were swollen. I also had trouble kneeling down and gained a lot of weight as a result of my reduced physical activity.

“I could see myself in a wheelchair if I had not received this treatment. I think it saved my life.”

As things progressed, I could not even go for a leisurely walk and if I did manage to go, I couldn’t get out of bed the next morning. My daily work routine became more difficult as time went on. It was hard just to kneel down to pick up my pen. I had stopped doing pushups due to wrist pain.

My doctor prescribed Celebrex for pain and inflammation. I started taking Humira until I went for a jog one day. The next day, I had a major flare up throughout my body. It never worked again after that so I stopped taking it. The Celebrex helped me get through the day at work but I was still in pain.

Then by chance, my mom read about a stem cell therapy seminar being hosted by Dusty Durrill at Del Mar College and my dad went to it. I was skeptical but decided to go since someone like Dusty, whom we knew from our community went himself and spoke so highly of it.

The doctors at the Stem Cell Institute were very professional and nice. They immediately established a close relationship with me and made me feel like a person, not just a number. It was very personal . They were open and answered all of my questions. They treated me like “Bryan”.

Even the office staff was very helpful with non-medical issues. I do customer service all day and while in Panama, I received much more than just “customer service”.

I also got to go on a tour of the laboratory. I found the Q&A particularly helpful. It was nice to have an opportunity to have all issues regarding stem cells addressed.

Since receiving stem cell therapy, my pain level has gone way down. I noticed changes the first day. My hands became less stiff and the pain I usually felt when clenching my hands was reduced.

Now, I still have a little morning stiffness but it goes away quickly. Before treatment, it would linger for an hour or two. My joints are still a little inflamed but I have so much less pain. I just bought a new gym membership. I play racquetball and work out on the elliptical machine. I can bend down and pick up a pencil again and I am still improving! I still take Celebrex for inflammation due to the amount of exercise I am doing but its effect on me is 10-fold since I got the stem cells.

I feel very blessed to have found this treatment because it has done wonders for me and I will continue to recommend the therapy to anybody that may benefit from it.

I could see myself in a wheelchair if I had not received this treatment. I think it saved my life.

Bryan Gamez
bjgamez@gmail.com

Stem cell therapy for rheumatoid arthritis: Kathleen Flores

“Since the treatment I have no pain; I feel really healthy and now I workout 3 times per week and I`m in better shape than I have been in years.”

I was diagnosed with Rheumatoid Arthritis by my rheumatologist 3 years ago. He wanted me to start some very strong drugs but I didn`t want them because I saw the secondary effects that they had on some of my friends that also have RA. I started searching for alternative options and thank God I found the stem cell treatment. Before my treatment I couldn`t walk without any help, could not climb stairs and I spent all day lying in bed because I felt sick.

After my first day of treatment I slept well, and after the 3rd and last treatment I was walking without any pain or help, it was amazing! Since the treatment I have no pain; I feel really healthy and now I workout 3 times per week and I`m in better shape than I have been in years. The Stem Cell doctors were wonderful with me and I highly recommend this treatment to any one with RA. The cost is not expensive compared to all the money I spent in meds and doctors before I got the stem cell treatment, in fact I save a lot of money.