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.”

New Study Suggests Healthy Donor Stem Cells Better Than MS Patient’s Own Stem Cells

Pre-Existing Inflammatory Diseases Reduce Therapeutic Potential of Stem Cells for MS Treatment, Study Shows

BY ALICE MELÃO (Original Story from Multiple Sclerosis News Today)

Pre-existing inflammatory diseases affecting the central nervous system make mesenchymal stem cells (MSCs) less effective in treating multiple sclerosis (MS), concludes a study by researchers at Cleveland’s Case Western Reserve University School of Medicine.

Diseases like EAE and MS diminish the therapeutic functionality of bone marrow MSCs, prompting re- evaluation about the ongoing use of autologous MSCs as a treatment for MS,” the team wrote, adding that its study supports the advancement of MSC therapy from donors rather than autologous MSC therapy to treat MS while raising “important concerns over the efficacy of using autologous bone marrow MSCs in clinical trials.

The study, “CNS disease diminishes the therapeutic functionality of bone marrow mesenchymal stem cells,” notes that MSCs potentially produce several signaling proteins that can regulate immune system responses as well as help tissue regenerate. Preclinical studies have shown that this can reduce brain inflammation while improving neural repair in animal models of experimental autoimmune encephalomyelitis (EAE). This model resembles the inflammation and neuronal damage seen in MS patients.

Given the need for effective new MS therapies, the results will help MSCs to advance to human clinical trials. So far, results have reported good safety data, though such therapies have failed to demonstrate therapeutic efficacy. Most such trials so far have used stem cells collected from the patient, a process known as autologous transplantation — yet this may explain why MSCs have not been effective. It’s possible that pre-existing neurological conditions may alter stem cells’ responsiveness as well as their therapeutic activity.

To see whether that is in fact the case, team members collected stem cells from the bone marrow of EAE mice. But these stem cells were unable to improve EAE symptoms, whereas stem cells collected from healthy mice retained all their therapeutic potential and improved EAE symptoms.

A more detailed analysis showed that the MSCs derived from EAE animals had different features than their healthy counterparts.

In addition, the team confirmed that MSCs collected from MS patients were also less effective in treating EAE animals, compared to MSCs from healthy controls. Indeed, these MSCs from patients produced pro-inflammatory signals instead of the protective anti-inflammatory ones.

“Diseases like EAE and MS diminish the therapeutic functionality of bone marrow MSCs, prompting re- evaluation about the ongoing use of autologous MSCs as a treatment for MS,” the team wrote, adding that its study supports the advancement of MSC therapy from donors rather than autologous MSC therapy to treat MS while raising “important concerns over the efficacy of using autologous bone marrow MSCs in clinical trials.”

Stem cell pioneer sets sights on Japan – Japan Times features Neil Riordan, PhD of Medistem Panama

Japan Times Article Medistem

“We enjoy the advantage of having a large amount of clinical data on 2,000 patients. So we analyzed who received which cells and which cells worked best in different conditions. This allowed us to create our selection process through molecular profiling,” explained Medistem (Panama) Founder and CEO Dr. Neil Riordan.

Operating what is arguably the country’s most advanced laboratory, an 8,000-sq-ft facility in the City of Knowledge science and technology cluster, Medistem has raised its profile in recent years as it develops stem cell-based products for clinical trials for treatment of autism, asthma, multiple sclerosis, osteoarthritis, rheumatoid arthritis and spinal cord injuries.

Utilizing its patented technologies, Medistem harvests human adult stem cells from umbilical cords, tissues and blood as well as from bone marrow and adipose tissue. “We have intellectual property on a methodology for basically defining which are good cells, which are mediocre and which are the useless ones. The U.S. Food and Drug Administration has approved our cells for compassionate use in the United States. This is a big step,” Riordan said.

Compassionate use, also known as expanded access, refers to the use of investigational new drugs outside of a clinical trial by patients with serious, life-threatening conditions. After finishing its first prospective clinical trial, and with six others in the pipeline, the company is considering the favorable regulatory conditions for cell therapy in Japan, now a promising market for its products.

“Japan has a law on the books that allows a company of our size to commercialize such products. That makes it our number one priority. We are gearing up to present our data to regulators, as well holding talks with potential partners over there,” Riordan added.

Why Stem Cells Work: Clinical Trials for Spinal Cord Injury, Multiple Sclerosis, Rheumatoid Arthritis, and Duchenne’s Muscular Dystrophy

Neil Riordan, PhD speaks at the Riordan-McKenna Institute and Stem Cell Institute fall seminar in Southlake, Texas on October 10, 2015.

Dr. Riordan discusses:

  • How our lab selects uses specialized screening techniques to select only the stem cells that we know will be the most useful for our patients. Only about 1 in 100 cords pass this screening process.
  • How umbilical cord mesenchymal stem cells (MSC) control inflammation, modulate the immune system and stimulate regeneration.
  • How the number and function of our own stem cells decline over time.
  • How MSC secretions promote healing
  • Where MSCs are found in our body
  • First clinic trial in the US using umbilical cord tissue-derived stem cells
  • How MSC doubling times dramatically decrease as people age, which is why cord cells are much more robust than a patient’s own cells as they age
  • The origin of Medistem Lab in Panama
  • Why the Stem Cell Institute and Medistem Labs are in Panama
  • Stem cell therapy laws and approvals around the world
  • Global interest in mesenchymal stem cell therapy research
  • Current clinical trials using mesenchymal stem cells
  • Clinical trials in Panama
  • Collaborations with corporations and educational institutions
  • Mesenchymal stem cell selection, donor selection, and testing
  • Brief tour of Medistem Panama stem cell laboratory
  • Isolation and production of mesenchymal stem cells
  • Discovery of mesenchymal stem cells in menstrual blood
  • Umbilical cord mesenchymal stem cell studies for rheumatoid arthritis
  • The role of T-regulatory cells in rheumatoid arthritis and multiple sclerosis
  • Treating spinal cord injuries with mesenchymal stem cells
  • Mechanism of mesenchymal stem cells on spinal cord injury. They are not becoming tissue. It’s their secretions that allow the spinal cord to heal itself.
  • Umbilical cord MSC studies on spinal cord injury
  • Data from Stem Cell Institute spinal cord injury patients
  • Video from treated spinal cord injury patients
  • Postnatal MSC safety
  • MSCs and cancer risk – MSCs have been shows to actually inhibit tumor growth

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.

Stem Cell Therapy for Multiple Sclerosis: Ron McGill

Ron McGill suffers from relapsing-remitting multiple sclerosis. He was started experiencing symptoms in 2009 but was not diagnosed with MS until January of 2013. He received several infusion and injections of human umbilical cord-tissue derived stem cells at the Stem Cell Institute in late October and Early November 2013.

In this video, Ron shares his story of discovery and recovery at a Stem Cell Institute seminar in San Antonio in October 2014.

For more information on MS therapy at the Stem Cell Institute in Panama, please visit: https://www.cellmedicine.com/stem-cell-therapy-for-multiple-sclerosis-3/

Good afternoon.

I was diagnosed with relapsing-remitting MS in January of 2013. My symptoms started with tingling and numbness in my hands and feet migraine headaches in April, 2009. Visits to the doctors concluded that job stress-related migraines were all it was.

My high tolerance for pain accepted the results and I went on with life. This was an extremely poor decision on my part. My symptoms remained constant but non-progressing until November of 2011. In attempting to kick a soccer ball, I lost my balance and I fell. I wrote it off as being out of shape and clumsy. A fall on a treadmill and down a stairwell in early 2012 was my final wakeup call. It solidified that there was more wrong with me than normal.

My quest to find out what was causing my issues and how to resolve them was started.

Starting from behind and (inaudible) to catch up, I did several things. I made immediate dietary changes. Sodas, fast food, canned food, alcohol – eliminated. Red meat, dairy, bread, pasta – reduced drastically. Chicken, fish, fresh fruits, vegetables – doubled. I went on a weight loss and body detox regimen. I replaced impact aerobic exercises I could no longer do with swimming.

I made the most of my insurance. I literally became a human pin cushion. Everybody was sticking me. I looked outside traditional medicine: acupuncturist, building my immune system and pure vitamin regimens. While I made great strides in changing my life, I was testing healthier, a progression of worse symptoms continued to happen. Severe leg and back aches, leg stingers, twitching, lost grip and more loss of balance.

It was determined that MS was my cause. My instability had me falling one to two times a month. I reached my lowest point waking up immobile from the waist down on a Wednesday morning in February of 2013.

With my motor skills seemingly erased from my memory, a deep cloud of panic overtook me. My confidence went out the window. I had to dig down extremely deep. I was able to regain mobility later that evening. I progressed to a penguin walk and very limited speed and distance over the next 6 months with the help of a walking stick and physical therapy.
Hours of online research for possible relief led to stem cell therapy.

After many months of research, doctor consultations, numerous conversations with people who had had stem cell therapy, heard about it, had relatives who had experienced it, I sent the email to the Stem Cell Institute.

After being accepted, I still had more conversations with Dr. Barnett and Cindy, asking more and more questions. They were extremely patient to everything I had.

The care provided for me upon my arrival and during my stay and departure in Panama was extremely good. The facility was simple, clean, efficient with a very helpful and friendly staff. The procedure was well-explained to me and carefully administered.

I was able to see results on my way back (on) November 3rd. I was able to walk farther and feel better. I was able to my walking stick in the back of my car for good two weeks later. Knock on wood, I haven’t fallen since October 23rd of 2013. My stamina, walking speed and stability have continued to increase. I do have momentary balance loss and heat can still wipe me out. My MS is still with me.

Do I feel (that) Panama was the right choice? For me, absolutely. I feel the infusion of healthy cells gave my body a huge boost to recover the majority of lost motor skills I had experienced. It also helped amplify the lifestyle changes I was already making to give me a faster and more positive result.

These successes have given me a more positive mental state that have allowed me to heal more and more.

What advice could I give you about stem cells? Research, research, research. There isn’t a price you can put on due diligence when it comes to your health. Make lifestyle changes at the cellular level in your body and amplify it with stem cell therapy.

In closing, I’d like to thank my wife for undying support and hours of research. I’d like to thank Dr. Riordan, (and) Stem Cell Institute for being at the cutting edge of healing diseases and I’d like to thank you all for allowing me to share with you today.

The Lip TV News: Neil Riordan, PhD on Exploring New Stem Cell Treatments for MS, Arthritis, Autism and More

Stem cell treatment and research towards curing illness–from multiple sclerosis to spinal injury–is detailed by Dr. Neil Riordan. The American medical industry, obstructions to research in the states, misconceptions about stem cells, and the details about the treatment process are explained–and we look at video of patient recovery and speculate at what the future could spell for stem cell treatment and research in this Lip News interview, hosted by Elliot Hill.

GUEST BIO:
Dr. Neil Riordan is the founder and Chairman of Medistem Panama, a leading stem cell laboratory and research facility – located in Panama City. His institute is at the forefront of research of the effects of adult stem cells on the course of several chronic diseases. Dr. Riordan has more than 60 scientific articles in international peer-reviewed journals. In the stem cell arena, he and his colleagues have published more than 20 articles on Multiple Sclerosis, Spinal Cord Injury, Heart Failure, Rheumatoid Arthritis.

Stem Cell Institute Welcomes Special Guest Speaker Roberta F. Shapiro DO, FAAPM&R to Stem Cell Therapy Public Seminar in New York City

Stem Cell Institute Welcomes Special Guest Speaker Roberta F. Shapiro DO, FAAPM&R to Stem Cell Therapy Public Seminar in New York City May 17th, 2014 (via PRWeb)

The Stem Cell Institute located in Panama City, Panama, welcomes special guest speaker Roberta F. Shapiro, DO, FAAPM&R to its public seminar on umbilical cord stem cell therapy on Saturday, May 17, 2014 in New York City at the New York Hilton Midtown…

Stem Cell Institute Public Seminar on Adult Stem Cell Therapy Clinical Trials in New York City May 17th, 2014

New York, NY (PRWEB) April 09, 2014

The Stem Cell Institute, located in Panama City, Panama, will present an informational umbilical cord stem cell therapy seminar on Saturday, May 17, 2014 in New York City at the New York Hilton Midtown from 1:00 pm to 4:00 pm.

Speakers include:

Neil Riordan PhD“Clinical Trials: Umbilical Cord Mesenchymal Stem Cell Therapy for Autism and Spinal Cord Injury”

Dr. Riordan is the founder of the Stem Cell Institute and Medistem Panama Inc.

Jorge Paz-Rodriguez MD“Stem Cell Therapy for Autoimmune Disease: MS, Rheumatoid Arthritis and Lupus”

Dr. Paz is the Medical Director at the Stem Cell Institute. He practiced internal medicine in the United States for over a decade before joining the Stem Cell Institute in Panama.

Light snacks will be served afterwards. Our speakers and stem cell therapy patients will also be on hand to share their personal experiences and answer questions.

Admission is free but space in limited and registration is required. For venue information and to register and reserve your tickets today, please visit: http://www.eventbrite.com/e/stem-cell-institute-seminar-tickets-11115112601 or call Cindy Cunningham, Patient Events Coordinator, at 1 (800) 980-7836.

About Stem Cell Institute Panama
Founded in 2007 on the principles of providing unbiased, scientifically sound treatment options; the Stem Cell Institute (SCI) 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.

In partnership with Translational Biosciences, a subsidiary of Medistem Panama, SCI provides clinical services for ongoing clinical trials that are assessing safety and signs of efficacy for osteoarthritis, rheumatoid arthritis, and multiple sclerosis using allogeneic umbilical cord tissue-derived mesenchymal stem cells (hUC-MSC), autologous stromal vascular fraction (SVF) and hU-MSC-derived mesenchymal trophic factors (MTF). In 2014, Translation Biosciences expects to expand its clinical trial portfolio to include spinal cord injury, heart disease, autism and cerebral palsy.

To-date, SCI 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

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 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 webSite: http://www.translationalbiosciences.com

Email: trials(at)translationalbiosciences(dot)com

Umbilical Cord Stem Cell Therapy Clinical Trial for Multiple Sclerosis Gets Green Light

Translational Biosciences Site Header

Dallas, TX (PRWEB) April 03, 2014

Translational Biosciences, a subsidiary of Medistem Panama, has received the green light for a phase I/II clinical trial using human umbilical cord-derived mesenchymal stem cells (UC-MSC) for multiple sclerosis from the Comité Nacional de Bioética de la Investigación (CNEI) Institutional Review Board (IRB) in Panama.

According to the US National Multiple Sclerosis Society, in Multiple Sclerosis (MS), an abnormal immune-mediated T cell response attacks the myelin coating around nerve fibers in the central nervous system, as well as the nerve fibers themselves. This causes nerve impulses to slow or even halt, thus producing symptoms of MS that include fatigue; bladder and bowel problems; vision problems; and difficulty walking. The Cleveland Clinic reports that MS affects more than 350,000 people in the United States and 2.5 million worldwide.

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

Each patient will receive seven intravenous injections of UC-MSC over the course of 10 days. They will be assessed at 3 months and 12 months 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. ISO-9001 certified laboratory in the prestigious City of Knowledge. They will be administered at the Stem Cell Institute in Panama City, Panama.

From his research laboratory in Dallas, Texas, Dr. Riordan commented, “Umbilical cord tissue provides an abundant, non-controversial supply of immune modulating mesenchymal stem cells. Preclinical and clinical research has demonstrated the anti-inflammatory and immune modulating effects of these cells. We look forward to the safety and efficacy data that will be generated by this clinical trial; the first in the western hemisphere testing the effects of umbilical cord mesenchymal stem cells on patients with multiple sclerosis.”

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

For detailed information about this clinical trial visit http://www.clinicaltrials.gov . If you are a multiple sclerosis patient between the ages of 18 and 55, 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@translationalbiosciences.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