Clinical Trials for Multiple Sclerosis and Rheumatoid Arthritis using Umbilical Cord Tissue Mesenchymal Stem Cells

Stem Cell Institute and Medistem Panama founder, Neil Riordan, PhD discusses clinical trials for multiple sclerosis and rheumatoid arthritis using umbilical cord tissue-derived mesenchymal stem cells at our fall stem cell seminar in San Antonio.

For more information about these trials and others, please visit www.translationalbiosciences.com. The multiple sclerosis trial is full but the RA trial is still recruiting as of November 24, 2014.

Highlights include:

How do we select umbilical cords for use? Medistem has identified proteins and genes in the cells that allow us to screen hundreds of umbilical cords to select only the ones containing the specific types of cells that have the best anti-inflammatory properties, the best immune modulating capacity and the best ability to stimulate regeneration.

How therapy using umbilical cord tissue-derived mesenchymal stem cells (MSCs) differs from bone marrow transplants used in cancer patients.

Properties of umbilical cord MSCs:

  • Modulate the immune system
  • Increase the number of T-regulatory cells
  • Block clonal expansion of activated T cells
  • MSCs in patients with autoimmune diseases don’t work properly

How demyelination occurs in MS patients and how MSCs act on the immune system to slow it down or stop it.

Treated MS patient follow-up survey results at 120 days and 1 year after treatment.

Television news story about Sam Harrell’s return to coaching football after severe MS symptoms forced him into early retirement.

Results from a 172 patient study on treating rheumatoid arthritis with intravenous umbilical cord tissue mesenchymal stem cells in which all patients improved.

Trial Information

These trials may be viewed on the National Institutes of Health web site www.clinicaltrials.gov

Umbilical Cord Tissue-derived Mesenchymal Stem Cells for Rheumatoid Arthritis

Feasibility Study of Human Umbilical Cord Tissue-Derived Mesenchymal Stem Cells in Patients With Multiple Sclerosis

Those interested in stem cell therapy for MS may still apply for private treatment on this site.

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.

Sam Harrell demonstrates his progress after receiving umbilical cord stem cells + fat stem cells for multiple sclerosis

Texas high school Hall of Fame football coach Sam Harrell talks about his progress after undergoing several stem cell treatments for secondary progressive multiple sclerosis at the Stem Cell Institute in Panama City, Panama.

Sam is speaking from the clinic in Panama while undergoing his fourth 5-day course of combination human umbilical cord-derived mesenchymal stem cells and fat-derived stromal vascular fraction cells.

“I came by myself this time and that’s just a sign of how much better I’ve gotten. …the last times I’ve come I had to get in a wheel chair [off the plane] and I just walked through the airport this time. People ask me. ‘Do you think it really helps?’. Well, just look! I am walking through the airport with no aids.” [Sam demonstrates how he used to walk before treatment] “I took little steps. If I needed to turn around, I had to do like this.” [Sam demonstrates a slow, shuffling turn] “I don’t have a rope but now I can jump rope.” [sam demonstates jumping rope and walks quickly around the room demonstrating quick changes in directions] “Before, I couldn’t jump rope. I couldn’t do any of that. Now I can do those things. I used to have to think about my steps. I’d have to think about right leg, and left leg and now I don’t have to think. I catch myself doing that. I walk somewhere and I think, ‘hey I didn’t have to think about walking from there to there. I just got up and walked like I used to. Now I can make quick moves. I couldn’t do any of that before.”

“…I coached football and I had to retire. I never thought I’d coach football again. Just this last year, I coached football again. Amazing. I thought I would never do that again. I coached this past year and I plan on doing it again. I’m thank to the Stem Cell Institute in Panama and I am thankful to God above. He’s smiling on me too. It’s an amazing story, I think.”

Sam Harrell Texas High School Football Hall of Fame: http://www.brownwoodnews.com/index.php?option=com_content&view=article&id=10918:harrell-to-be-inducted-into-the-texas-high-school-football-hall-of-fame&catid=39:sports&Itemid=62

Links:

Stem Cell Therapy for MS

More Patient Stories

Safety and immunological responses to human mesenchymal stem cell therapy in difficult-to-treat HIV-1-infected patients.

Zhang Z, Fu J, Xu X, Wang S, Xu R, Zhao M, Nie W, Wang X, Zhang J, Li T, Su L, Wang FS.
Research Center for Biological Therapy.

Link to Abstract on National Institutes of Health Website

Abstract

OBJECTIVE:
HAART largely decreases morbidity and mortality in chronic HIV-1-infected patients, but immune nonresponders (INRs) with full viral suppression still fail to reverse the immune deficiency. This study evaluated the safety and immunological responses of human umbilical cord mesenchymal stem cell (MSC) therapy in HIV-1-infected INRs.

DESIGN AND METHODS:
A total of 13 HIV-1-infected INRs were enrolled in this pilot prospectively open-labeled controlled clinical trial. Seven patients were administered three umbilical cord-MSC transfusions at 1-month interval during 12-months of follow-up, whereas six control patients were treated with saline in parallel. Immunological parameters were monitored in these patients throughout the trial.

RESULTS:
All patients tolerated the umbilical cord-MSC transfusions well throughout the trial. The umbilical cord-MSC transfusions preferentially increased circulating naive and central memory CD4 T-cell counts and restored HIV-1-specific IFN-γ and IL-2 production in the INRs. These enhancements in immune reconstitution were also associated with the reduction of systemic immune activation and inflammation in vivo.

CONCLUSIONS:
umbilical cord-MSC transfusions are well tolerated and can efficiently improve host immune reconstitution in INRs, suggesting that such treatments may be used as a novel immunotherapeutic approach to reversing immune deficiency in HIV-1-infected INRs (ClinicalTrials.gov identifier: NCT01213186).

Umbilical Cord Stem Cells: Regeneration, Repair, Inflammation and Autoimmunity – Neil Riordan PhD (Part 2 of 2)

In part 2, Dr. Riordan discusses how mesenchymal stem cells can affect tissue repair in spinal cord injury and in heart failure; benefit to heart is not the actual MSCs modeling new tissue. It is due to the trophic effects of MSC secretions; In rats, severed spinal cords re-grew after MSCs were implanted but the human MSCs did not form new cord tissue. The trophic factors secreted by the MSCs enable the spinal cord to repair itself.; Trophic factors from MSCs modulate the immune system by blocking clonal expansion of cytotoxic T-cells; There are 35 ongoing clinical trials using mesenchymal stem cells for autoimmune diseases; Safety of donor MSCs; Every mother has MSCs from each baby she has carried; Mothers have a lower incidence of autoimmune disease; Lifespan of mothers increased linearly with each child up to 14; There are 85 ongoing clinical trials using donor MSCs. Allogeneic MSCs from bone marrow have been approved in Canada and New Zealand to treat graft vs. host disease; limbal cells used in corneal transplants are MSCs; MSCs are useful in preventing donated organ rejection; glioma growth was found to be inhibited by MSCs; MSCs eliminated breast cancer in rats.

VIDEO – The Science of Mesenchymal Stem Cells and Regenerative Medicine – Arnold Caplan PhD (Part 4)

In part 4, Prof. Caplan talks about isolating mesenchymal stem cells from bone marrow using specialized; calf serum choosing different assays to prove multipotency – osteogenesis, chondrogenesis, adipogenesis; point of care with autologous bone marrow in orthopedic surgery; tissue engineering bone with lineage restricted MSCs; banking bone discarded bone marrow from orthopedic surgeries for future use;

Stem cell therapy for knees, osteoarthritis and autoimmune disorders: King Goff

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 Stem Cell Institute in Panama. In this video, Mr. Goff discusses conventional treatments he received before stem cells, pre-treatment symptoms, post-treatment improvements, the doctors and staff, and the clinic.

“My immune system is the thing that is noticeably better. My allergies have corrected. The sinusitis circumstances that I was having problems with have corrected, in part but not completely. My knees, I’m up to being able to be on fairly distant walks of one and a half to two miles as part of my exercise program without the pain that I experienced prior to the [stem cell] treatment. Those are the most significant gains that I can say; just a lack of pain and increased mobility.” – King Goff

Stem cell treatments for rheumatoid arthritis: Tracey Renneberg

Tracey Renneberg discusses her improvements following stem cell therapy for rheumatoid arthritis. Tracey is now in Panama multiple sclerosis treatment. “My rheumatoid arthritis is completely gone. This leg used to drag and now I can pick it up and walk. If patients have rheumatoid arthritis or MS, this is where they should be.”

Mesenchymal Stem Cells in Regenerative Medicine:Mechanisms of action, sources, and delivery options

Neil Riordan, PhD, Founder of the Stem Cell Institute in Panama City, Panama will be speaking today, Wednesday, Feb 6 at the STEMSO International Stem Cell Society 2013 Conference in Fort Lauderdale, FL.

The topic of Dr. Riordan’s discussion will be “Mesenchymal Stem Cells in Regenerative Medicine:Mechanisms of action, sources, and delivery options”

The theme for this year’s event is “Autologous Stem Cells: Who gets to decide…”

2013-02-06T15:07:38+00:00 February 6th, 2013|Adult Stem Cells, neil riordan, News, Stem Cell Research|

Stem cell treatments for chronic fatigue syndrome: Susan Lucey

“First I must say I have been steadily getting better. Everyone notices it. My long distance friends have all commented on the vitality and clarity in my voice. So much is changing in my body for the better. I can’t thank the staff at the SCI enough for saving my life. And of course, my beloved Dr Cheney, who knew better than anyone how sick I was … I feel such gratitude.

I was slipping into dementia from severe and unremitting CFS. I was desperate for help and when Dr Cheney invited me to go there in May, in my heart I knew I was going to get my life back. I was so sick that almost any quality of life was gone for me and I either wanted to die or get better. I was at the end of my rope as I was in constant and unrelenting pain, slipping away with dementia and fully bed-bound and home bound for several years after being vibrantly alive, loving life as an artist and a professor at the University of Minnesota, mother, wife and lover of life.

“I’ve regained peristalsis after 13 yrs. No more falling! No more chest pain, no more visits to the ER! I wake up the each day full of energy, not crashed. Thank you from the bottom of my heart… “

Although I state very enthusiastically my improvements, I still have a way to go; but because the improvements have been so marked I feel like there has already been an amazing transformation. Here are some of the improvements:

  • Anyone who speaks to me on the phone comments on how well I sound. Lately, I have heard in my voice an “authority” and sense of articulation that I once had when I was a professor and artist. My brain is healing and I have energy everyday. I still must rest most days but I want to get up and begin to rebuild my life. Incipit Vita Nova- Here begins the new life! I feel inspired! Before stem cells, I spoke often in a whisper as my vocal cord were weak and I would quickly tire, slur my speech and need to stop talking as it would exhaust me. I easily crashed from less than 10 minutes of phone conversation.
  • Comments from friends regarding getting well- ”woo yaa! Susan, you are lucid!” “You are back!…”look at you, your cognitive function is so much better.” I hear these comments everyday.
  • I was able to titrate from 40 mg to 5 mg of Cortef shortly after my 2nd visit to Panama. Now I plan to titrate off Cortef completely. With that, the bloating and weight gain is finally coming off my body.
  • I’ve regained peristalsis after 13 yrs.
  • No more falling! My balance is good and am able to climb out of, for example, a bath tub – I’m getting stronger! Falling was a constant worry and I did eventually fall and break my back recently. That was the final straw and I developed PTSD. I feel less pain now in the area of the herniated discs and I wonder if the stem cells will repair such injuries . Falling was a constant worry for my husband, there was a sense that my feet were not connected to my brain. Now that worry is in the past.
  • No more chest pain, no more visits to the ER! (15 visits last year!)
  • Fat turning into muscle, I can now stand up from a sitting position without the help of my arms pressing me up. My family comments on my form transforming.
  • Overall, more resiliency, vitality and cognitive improvement.
  • I am able to organize. I’ve been able to declutter and organize much of the piles of paperwork and miscellanea that have been piling up for a decade. . CFS made organizing impossible for me. I’ve heard that this is not uncommon.
  • I now have the energy to stay focused for 2 – 4 hrs at a time sitting in a chair doing paperwork or some task ( I have not had the strength to sit in a chair for 5 – 6 yrs. I wake up the each day full of energy, not crashed. Although I do feel muscle and joint pain from moving and so still need pain meds. But the most important thing is I rarely crash. I can be modestly active every day.
  • Memory! Although not perfect (I believe in part due to morphine) I am so much better. I can remember combinations of numbers on the spot. I know what I did the day before, the week before and what is planned in the future. I can remember what I wanted to do from day to day.

I am able to feel inspired and that is carried through the day to the next and the next. No amount of occupational therapy with strategies to support my memory ever worked. It’s hard to explain how far gone I was. I was lost to myself and I think it was the most terribly painful part of my experience of CFS. Regaining myself did not begin until after I was home from the 2nd stem cell protocol. And I am certain I needed the 30 day MS Protocol. None of these brain problems improved the first time and I could feel I was on a slow and disappointing slide backwards.

I wanted to thank you for all you have done for the benefit of myself and my family. My daughter, who moved home to help me out, has tears well up in her eyes regularly when she sees me interact with her in ways I haven’t since she was 14. You have been a bright light in the dark and desperate days of severe CFS. Thank you from the bottom of my heart from me and from that of my beautiful family, Chris and Christina.”

– S.L.