Treatment with Umbilical Cord Stem Cells Safe with Sustained Benefits for MS, Trial Shows

Image of GMP syringe prep lab at Stem Cell Institute clinic in Panama.

Stem cells being prepared for treatment.

March 20, 2018
Jose Marques Lopes, PhD
Link to Original Story at Multiple Sclerosis News Today

Treatment with umbilical cord [tissue-derived mesenchymal] stem cells was found to be safe and leads to sustained improvements in disability and brain lesions of multiple sclerosis (MS) patients, according to a clinical trial.

The study, “Clinical feasibility of umbilical cord tissue-derived mesenchymal stem cells in the treatment of multiple sclerosis,” was published in the Journal of Translational Medicine.

Although current treatments for MS are able to reduce the frequency of flare-ups and slow disease progression, they are not able to repair the damage to nerve cells or the myelin sheath, the protective layer around nerve fibers.

Mesenchymal stem cells (MSCs) are adult stem cells found in multiple tissues, such as umbilical cord, bone marrow, and fat. These cells are able to mature into bone, cartilage, muscle, and adipose tissue cells.

MSCs may inhibit immune-mediated alterations. In particular, MSCs derived from the umbilical cord have a high ability to grow and multiply, increase the production of growth factors, and possess superior therapeutic activity, compared with other MSCs.

Diverse clinical studies have shown that MSCs can safely treat certain immune and inflammatory conditions, including MS.

The research team had previously demonstrated that MSCs can also improve cognitive and motor function.

Recent results with placenta or umbilical cord MSCs showed few mild or moderate adverse events, as well improvements in patients’ level of disability.

Researchers at the Stem Cell Institute in Panama have now completed a one-year Phase 1/2 clinical study (NCT02034188) to test the effectiveness and safety of umbilical cord MSCs for the treatment of MS.

The trial included 20 MS patients with a mean age of 41 years, 60 percent of whom were women. Fifteen participants had relapsing-remitting MS, four had primary progressive MS, and one had secondary progressive MS. Patients’ disease duration was a mean of 7.7 years.

Participants received seven intravenous infusions of 20×106 umbilical cord MSCs over seven days. The treatment’s effectiveness was evaluated at the start, at one month, and at one year after treatment.

Assessments included evaluating brain lesions with magnetic resonance imaging (MRI) and disability based on the Kurtzke Expanded Disability Status Scale (EDSS), as well as validated MS tests for neurological function, hand function, mobility, and quality of life.

Patients did not report any serious adverse events. Most mild adverse events possibly related to treatment were headaches, which are common after MSC infusions, and fatigue, which is common in MS patients, the authors observed.

Improvements were most evident at one month after treatment, namely in the level of disability, nondominant hand function, and average walk time, as well as bladder, bowel, and sexual dysfunction. Patients also reported improved quality of life.

MRI scans at one year after treatment revealed inactive lesions in 15 of 18 evaluated patients. One patient showed almost complete elimination of lesions in the brain, which “is a particularly encouraging finding,” the researchers wrote.

At the one year point, improvements in disability levels were also still present, and could translate into improved ability to walk and work without assistance.

“The potential durable benefit of UCMSC [umbilical cord MSC] at 1 month, and sustained in some measures to 1 year, is in stark contrast to current MS drug therapies, which are required to be taken daily or weekly,” the researchers wrote.

The safety of the treatment is another advantage over available MS therapies, the team said.

They concluded that “treatment with UCMSC intravenous infusions for subjects with MS is safe, and potential therapeutic benefits should be further investigated.”

Bixby family raises money for son with cerebral palsy to receive second round of stem cell therapy

Stem Cell Recipient Easton WallaceBIXBY, Okla. – A Bixby family has new hope for their three- year-old son with cerebral palsy. Easton Wallace went to Panama last year to receive stem cell therapy. Unfortunately, the therapy is not FDA-approved in the United States.

The Wallace family held everything from spaghetti dinners to golf tournaments to raise the money for their son’s first treatment. His mother believes it was worth it. She says Easton is learning to talk and gain upper body strength. That is why she is hoping to raise enough money for a second treatment.

“He’s the happiest little boy ever. He can make anyone smile. He’s always smiling,” says Cassie Wallace.

Easton Wallace is a typical toddler. He loves playing outdoors and spending time with family. But unlike most other kids, Easton is living with spastic quadriplegic cerebral palsy, which affects every aspect of his life.

“He can’t sit unattended. He can stand up. He can’t crawl or walk or anything like that,” says Cassie. “He has trouble with his fine motor skills, eating.”

It’s hard for Cassie to watch her son struggle. But she says Easton’s infectious smile and loving personality give her strength.

She told 2 Works for You, “I try to be positive. We are just trying to everything we can for him to give him the best life possible. He has such a positive attitude. He’s so happy and determined. So I think that makes it easier.”

Cassie says a big part of giving Easton the best life possible, is taking him to Panama to receive Stem Cell therapy. She says the $20,000 treatment is not covered by insurance.

Easton’s first treatment was last December. Cassie say it’s working

“He’s repeating everything. He’s putting more words together. It’s really been helping.”

Cassie showed 2 Works for You video of Easton pushing himself in a device called a “pacer” for the very first time. She says this was a big day for their family because they never know for sure what milestones their child will get to experience. That’s why she and her family are trying to raise enough money to cover the expenses for another trip to Panama in December of this year.

The family is organizing another golf tournament in Sapulpa on August 29 at Clary Fields Golf Club. The event is called the “Easton Open.” There is still time to sign up by calling 918-248-4080.

You can also donate directly to the cause by logging on to Easton’s give forward page here.

Original Story and Video on KJRH Tulsa Website

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.

Panama’s First Umbilical Cord Stem Cell Clinical Trial for Rheumatoid Arthritis Approved by Comité Nacional de Bioética de la Investigación Institutional Review Board

Translational Biosciences Site Header
Panama City, Panama (PRWEB) January 14, 2014

Translational Biosciences, a subsidiary of Medistem Panama has received the county’s first clinical trial approval for the treatment of rheumatoid arthritis with human umbilical cord-derived mesenchymal stem cells (MSC) from the Comité Nacional de Bioética de la Investigación Institutional Review Board (IRB).

Rheumatoid Arthritis (RA) is an autoimmune disease in which the patient’s immune system generates cellular and antibody responses to various components of the joint such as type I collagen. As a result of this immune response, not only does joint destruction occur, but also other secondary complications such as pulmonary fibrosis, renal damage, and even heart damage. RA affects approximately 0.5-1% of the population in the United States.

Mesenchymal stem cells harvested from donated human umbilical cords after normal, healthy births possess anti-inflammatory and immune modulatory properties that may relieve RA symptoms. Because they are immune privileged, the recipient’s immune system does not reject them. These properties make MSC interesting candidates for the treatment of rheumatoid arthritis and other autoimmune disorders.

Each patient will receive five intravenous injections of umbilical cord stem cells over the course of 5 days. They will be assessed at 3 months and 12 month primarily for safety and secondarily for indications of efficacy.

The stem cell technology being utilized in this trial was developed by Neil Riordan, PhD, founder of Medistem Panama. The stem cells will be harvested and processed at Medistem Panama’s 8000 sq. ft. laboratory in the prestigious City of Knowledge. They will be administered at the Stem Cell Institute in Panama City, Panama.

The Principle Investigator is Jorge Paz-Rodriguez, MD. Dr. Paz-Rodriguez also serves as the Medical Director at the Stem Cell Institute.

“While this is just the first step, it is our hope that Panama’s rapid emergence as a leader in applied stem cell research will lead to safe, effective treatments for debilitating diseases such as rheumatoid arthritis and serve to benefit all Panamanians who suffer from it in the not-too-distant future,” said Ruben Berocal, M.D., National Secretary of Science, Technology and Innovation (SENACYT). “Oversight by the National Committee for Investigational Bioethics ensures patient safety by demanding ethical transparency and compliance with the highest levels of international standards,” he added.

For detailed information about this clinical trial visit http://www.clinicaltrials.gov. If you are a rheumatoid arthritis patient who has not responded to disease modifying anti-rheumatic drugs (DMARD) for at least 6 months you may qualify for this trial. Please email trials(at)translationalbiosciences(dot)com for more information about how to apply.

About Translational Biosciences

A subsidiary of Medistem Panama Inc., Translational Biosciences was founded solely to conduct clinical trials using adult stem cells and adult stem cell-derived products.

Translational Biosciences Web Site: http://www.translationalbiosciences.com

Email: trials(at)translationalbiosciences(dot)com

About Medistem Panama Inc.

Since opening its doors in 2007, Medistem Panama Inc. has developed adult stem cell-based products from human umbilical cord tissue and blood, adipose (fat) tissue and bone marrow. Medistem operates an 8000 sq. ft. ISO 9001-certified laboratory in the prestigious City of Knowledge. The laboratory is fully licensed by the Panamanian Ministry of Health and features 3 class 10000 clean rooms, class 100 laminar flow hoods, and class 100 incubators.

Medistem Panama Inc.
Ciudad del Saber, Edif. 221 / Clayton
Panama, Rep. of Panama

Phone: +507 306-2601
Fax: +507 306-2601

About Stem Cell Institute Panama

Founded in 2007 on the principles of providing unbiased, scientifically-sound treatment options, the Stem Cell Institute has matured into the world’s leading adult stem cell therapy and research center. In close collaboration with universities and physicians world-wide, our comprehensive stem cell treatment protocols employ well-targeted combinations of autologous bone marrow stem cells, autologous adipose stem cells, and donor human umbilical cord stem cells to treat: multiple sclerosis, spinal cord injury, osteoarthritis, rheumatoid arthritis, heart disease, and autoimmune diseases. To-date, the Institute has treated over 2000 patients.

For more information on stem cell therapy:

Stem Cell Institute Website: http://www.cellmedicine.com

Stem Cell Institute
Via Israel & Calle 66
Plaza Pacific Office #2A
Panama City, Panama

Phone: +1 800 980-STEM (7836) (USA Toll-free) +1 954 636-3390 (from outside USA)
Fax: +1 866 775-3951 (USA Toll-free) +1 775 887-1194 (from outside USA)

Stem Cell Therapy for Autism – Amazing QEEG Results of Kenneth Kelley!

Original Post by Marty Kelley, Kenneth’s mother on July 18, 2013

This is Kenneth’s QEEG scans from 2007, two years before adult stem cells, and 2013 after six adult [uman umbilical cord] stem cell treatments. These are huge improvements. Dr. {Sandlin) Lowe said that the 2007 scan looks like borderline seizures and would indicate that the brain was leading up to develop seizures. Dr. Fallapour told me that many areas in the brain are now functioning normally!!!

Ken Kelley QEEG scan at 7 years old

This is the 2007 scan when Ken was six years old.



Ken Kelley QEEG in 2013 at age 12.  Wow!

This is Ken’s scan today, 2013 at age 12! Wow!



Ken's QEEG comparison.

Ken’s QEEG comparison.

Notice how almost all the red area is gone in the first head image! The other pictures show huge improvements, as well! See all the color changes indicating brain improvement. Green is normalized activity.

Today, the scans show that Ken has really good impulse control and there is no signs of Attention Deficit Disorder. Also, the brain is functioning normally, there are no longer any learning disabilities showing up in the scans.

2013-07-19T17:43:54+00:00 July 19th, 2013|Autism, Autism, News, Patient Stories, Stem Cell Therapy, Uncategorized|

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 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.

Stem cell therapy for multiple sclerosis: Holly Huber

Holly Huber shares her uplifting story about receiving stem cell therapy for MS at the Stem Cell Institute in Panama City, Panama. Ms. Huber was speaking at a stem cell seminar in San Diego, CA.

Read Holly’s Blog – I Love My New Stem Cells