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.”

Joe Rogan Interview with Mel Gibson and Dr. Riordan

Joe Rogan interviews Stem Cell Institute founder Neil Riordan, PA, PhD and award-winning actor, director and producer Mel Gibson, who first brought his father to Panama at the age of 92.  Mel discusses his father’s miraculous recovery.  He is now 99.  Dr. Riordan discusses stem cell therapy using human *umbilical cord-derived mesenchymal stem cells including their application in conditions like multiple sclerosis and autism.

*umbilical cords are donated following normal, healthy births

Podcast: Listen to Dr. Mike Hutchinson, DVM interview with Dr. Riordan about stem cell therapy

About This Episode

Delve deeper into the stem cell world with pioneer and expert Dr. Neil Riordan. Co-founder/chief science officer of the Riordan-McKenna Institute, founder/chairman/chief science officer of the Stem Cell Institute and author of Stem Cell Therapy: A Rising Tide, he’s here to discuss ongoing stem cell studies with Duchenne Muscular Dystrophy, spinal cord injuries, MS, autism and more. He’ll also answer one of the most common stem cell questions: how can one cell treat so many different conditions?

View on drmikehutchinson.com

Stem Cell Therapy for Autism – Brady B’s Story

Interview with the parents of Brady B, during his second round of stem cell therapy for autism at the Stem Cell Institute in Panama using *umbilical cord tissue-derived mesenchymal stem cells.

For more information, visit: https://www.cellmedicine.com/stem-cell-therapy-for-autism/

*umbilical cords donated after normal, healthy births

Interview Transcript

Interviewer: Today is December 22nd 2017. Please give your names.

Michele: Steve and Michelle Bacon and this is Brady.

Interviewer: Brady’s diagnosis?

Michele: Brady was diagnosed when he was two and a half with autism.

Interviewer: So, this would be his second stem cell treatment?

Michelle: Umm, hmm.

Interviewer: The first treatment was performed when?

Michelle: April, 2017.

Interviewer: Can you describe his improvements?

Michelle: The first round of stem cells, after the second infusion, we were putting him to bed that night and he said spontaneously, without any requests or anything, us prompting, nothing…his first 3-word sentence. He said, “I want pizza.”

Steve: When Brady was diagnosed he was, or is diagnosed as non-verbal. So that was a complete surprise that he came up with a spontaneous 3-word phrase.

Michelle: And before that, he had only been doing like “echoing” and a lot of it was not understandable to everyone. I mean, we understood because we know him but other people wouldn’t have been able to understand.

Steve: Since stem cells, he’s become more patient and able to wait for things and not have to quick go and do something. He can stand in a line and wait now.

Michelle: He’s more… His school reported that he is more tolerant of transitions, like when they’re transitioning from a preferred activity to, like, work, like a work sheet – school stuff.

Steve: He’s able to read some sight words now since…

Michelle: About 30. Yeah, he can read words now. He wasn’t able to do that before. He can… It started out just recognizing like, from an array of three pictures, and then he would have like, “apple” or “banana” and he’d have a horse and a pencil and a banana and he cold match the word “banana” to the picture. And he would trade out the words and he could correctly identify which word went with which picture. And now, all we need is the flashcard of the word, no pictures, just like “horse” or “yellow”. And he can identify about 30 words. 30 or 40 words.

Steve: And he can now read some simple sentences with the sight words in it that he knows. And this is all new since stem cell treatments.

Michelle: Yeah, a lot more tolerant. Eye contact is better. He seeks out peers to play now whereas he didn’t before. Greetings are better – like “Hi” and “Bye”. Still working on the eye contact though. That one’s still kind of tough. He can look at you in a mirror, do eye contact in a mirror but the face is a little hard still.

Interviewer: Ok, anything else that you’d like to mention?

Michelle: Anything else guys?

Brother: He’s my brother.

Sister: [Inaudible]

Steve: More interactive with peers and family members.

Michelle: He’s definitely more interactive with everyone.

Interviewer: Ok.

Michelle: And no.. Oh yeah! He used to, it was hard always to get him to come out of his room. He would just want to sit in his room and play on his iPad and now he actually comes out and he sits with us a lot more. And he’s a lot more interactive with the family. We used to have a hard time getting him to stay at the table for dinner and now, he stays at the table no problems. He used to have meltdowns that would last 20 or 30 minutes. Now, he turns around in like, a minute. It’s so much better. His temperament is a lot better. I mean, he’s always been a very good boy but he gets rigid about things, you know? If he doesn’t have it just that way, it’s a 20 – 30 minute meltdown – before. Now, it’s much better.

Interviewer: Ok. That’s it. Thank you very much.

Everyone (including Brady): Cheese!

Stem Cell Therapy for Autism – Clara Goodman: ‘Never Give Up on Your Child’

Image of stem cell therapy patient Ari Goodman

 

By Jill Kirsch | December 28, 2017
Original Publication on Jewish Link of New Jersey

Following Ari Goodman’s first stem cell therapy last year, to treat what doctors called severe low-functioning autism, The Jewish Link reported on his progress and his family’s hope that they would be able to help him continue his journey towards recovery.

Ari was first diagnosed seven years ago, after he began losing skills at the age of 18 months. His mother, Clara, and father, Daniel, a 1990 graduate of Frisch who grew up in Parsippany, explored all therapies available to Ari, but nothing was able to reach him.

The family persevered, finally learning of the Stem Cell Institute, a facility in Panama that was known for successfully administering stem cell therapy to patients with autism. Clara and Daniel were determined to help Ari receive that treatment but, with the procedure and other costs totalling nearly $20,000, they feared it was beyond their reach.

Clara, ever her son’s champion, reached out to The Jewish Link, seeking assistance in sharing her family’s story, and the response went well beyond what they imagined. The Goodmans, residents of East Windsor, were able to take Ari for his first treatment in May of 2016, and the results, noted Clara, were “miraculous.” Within weeks the family saw Ari begin “coming back to us. We started to see changes,” she said.

Feeling eternally grateful to the greater Jewish community for its help, and hopeful for the first time in years, Clara again reached out, in December of 2016, through a follow-up article in The Jewish Link. This time the Goodmans were not surprised by the outpouring of support, but just as grateful. “It is amazing how many people are right there with us. Everyone who has cared about our story has helped in some way,” Clara remarked.

Ari, now 9 years old, received his second stem cell therapy earlier this year, and Clara was thrilled to discuss his progress with The Jewish Link. “Since February, his awareness of everything is 100 percent there,” she said. “He responds. His receptive language is amazing. He’s able to answer questions. He just knows everything and has opinions.”

Clara reports that Ari is now able to spontaneously ask for things and express wants and needs, though still only using one word at a time. “He has a sense of humor now. He laughs,” she said.

He is able to read sentences, and can spell words and put them together to form sentences. In fact, at school Ari is no longer in the class for children with autism; his progress has allowed him to move to a class for students with “multiple disabilities,” where the students are more social and conversational. His teachers have told Clara that Ari adds much to the classroom, and both students and teachers enjoy having him there.

“My hope is that he’ll develop more language,” said Clara. “I hope to mainstream him and maybe have him attend a Jewish school one day. We would love for him to learn Torah every day.”

For the first time, Clara is anxiously awaiting Ari’s annual IEP (Individualized Educational Plan) meeting next month, as she has already been told by his teachers that he has met all of his goals and they want to expand on that for next year. “I used to dread those meetings,” she stated. “Now I can’t wait. I’m looking forward to every day and seeing what new things he can do.”

Ari is “loving and affectionate, full of hugs and kisses,” Clara reported. “Doctors said he’d never do that.”

She continued, “We were told he would never be able to do any of these things. He is showing more every day that he’s whole. It’s in there and once the stem cells heal him it will all come back. He is proving everybody wrong and showing that Hashem is in charge, not any doctor.”

The Goodmans are hoping that a third treatment will “show more revealed miracles,” added Clara. He’s not conversational yet; I want the social aspect to come. I know he’s not out of the woods yet. He has a long way to go,” but “every time we go we see more and more improvement.”

While trials using adult stem cells are now ongoing at Duke University in North Carolina, America still does not have any treatments available that might benefit Ari. “We are that much closer to the FDA approving treatment,” Clara said. “But even then it still might not be covered.”

In the meantime, the Goodmans believe they must continue these treatments. “The stem cell therapy is allowing him to respond to all the therapies that weren’t working before. His body is healing and is open to it now,” added Clara.

“I feel like I have him back again and it’s the most wonderful feeling in the world,” she continued. “We felt like we lost him when he was diagnosed. Ari is proof that miracles do happen.”

“Ari has been through so much and he is still such a happy kid. He inspires others. I really believe that his mission in life is to heal the world; he’s helping us all be better people,” Clara stated. “His middle name is Netanel, which means ‘gift from God.’ He really is.”

Clara hopes that her family’s journey will provide strength to others who have children with autism. “There is an answer. Don’t ever give up on your child,” she said.

To help the Goodman family provide another stem cell treatment for Ari, please visit www.gofundme.com/aristemcelljourney or, to make a tax-deductible donation, send a check payable to “Congregation Toras Emes,” with “for Ari Goodman” noted in the memo line, and send ℅ Clara Goodman to 523 Nettleton Drive, East Windsor, NJ 08520.

By Jill Kirsch

Video: Stem Cell Therapy in Panama with Dr. Riordan and Mel Gibson

Host Michael Beattie discusses stem cell therapy using *human umbilical cord tissue-derived mesenchymal stem cells (hUCT-MSCs)  at the Stem Cell Institute in Panama with renowned applied stem cell scientist and founder, Neil Riordan, Pa, PhD and acclaimed actor, director and producer Mel Gibson.

Dr. Riordan discusses the miraculous progress of a spinal cord injury patient and pilot whose doctors said that he would never walk again.  He talks about where the stem cells come from, how they work and why they can treat so many seemingly different conditions.  Dr. Riordan explains how umbilical cords, and subsequently, hUCT-MSCs used at the Stem Cell Institute are carefully selected using molecular screening.  He also discusses why mesenchymal stem cells from umbilical cords function better than MSCs from adults, especially as they age or if they are suffering from a disease like multiple sclerosis.  For example. MSCs from a newborn multiply exponentially compared to MSCs from an older adult.

Mel Gibson discusses his father’s miraculous recovery, literally from his deathbed after receiving hUCT-MSCs at the age of 92.  He’s currently 99 and still going strong having been treated in Panama several times since then.  Mel also discusses his personal experiences in Panama.

Watch all this and more.

*umbilical cord tissue harvested after normal, healthy births

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 Therapy for Multiple Sclerosis – Wes Meadlock

Transcription from Telephone Interview with MS stem cell patient, Wes Meadlock.

I’ll start from the beginning and tell you what I know.

In 2011, I started feeling something was wrong, and went to a neurologist here in town, went to his MRIs, and all his little testing, and this and that, and he said, “You’ve either got Lyme’s disease or MS.” The reason they said Lyme disease is because we have a place deep in the woods, and we stay there a lot on the weekends for a couple of years, and I got a lot of tick bites. We went through the whole thing of MS or Lyme’s disease, so I was thinking, maybe that’s what I got?

I’m not quite normal but I’m pretty close, at 80-85% of being normal. …but compared to some other people I know who have MS that I’ve done some aquatic classes with, I am far superior to them. I really believe this stuff works.

In the meantime, my father’s wife has had cancer pretty bad a couple of times, and he knows a lot of people at U. of Alabama at Birmingham; a really good hospital. He said, “I know somebody up here who’s really good with MS, why don’t you come up here and have him test you.” So, I went up there in the fall of 2012 and he did his testing, and he was telling me, “You have MS.” He said he could get me into some clinical trials, and I was thinking, “I don’t like pharmaceutical drugs.” I said, “If I could find something else, some other way, I’m going to try it.” I’ve been doing a lot of Internet research and talked to a few other people who said you should try some stem cells, so I did that. I went to Panama the first time. I did the liposuction, and they tried to get 90 million cells from me, and they could only get 45 million. I’m rather thin and wasn’t in too good a health at the time. They said, “We’ll mix it with some umbilical cord to get you the 90 million, so you’ll get 45 of your own and 45 of umbilical, and I think that was a two week ordeal to get that treatment.

I came back home and was feeling so much better. At that particular point I was having a problem walking with my left leg not cooperating, so when I came back from there, I felt like I’d gotten a good bit better. So, I decided to go back the following year. 2013 was the first time I went, and in 2014 they said, “Do you want to do umbilical?” I said no I do not, so they said they’d try something else. It turned out to be the umbilical cord cells, and when I got done a doctor told me, “You should be good for three years.” That’s where I am now, and I decided in the last few months that I need to go back again. When I called they said they had an opening on March the 13th and I said, “Okay, I’ll take it.” I just felt like, basically I don’t do any other drug, and I do believe it helps. The only one I do now is Naltrexone. It’s a 4.5mg dose of that and it sure helps my coordination and my walking. I’m not quite normal but I’m pretty close, at 80-85% of being normal. That’s about where I am now.

I’m not 100% but compared to some other people I know who have MS that I’ve done some aquatic classes with, I am far superior to them. I really believe this stuff works.

When I went back the second time, I’ve noticed a lot of difference there, I’m a full believer that stuff pulled from your own fat, and I’m 62 years old, can’t be as good as umbilical cord stuff and the way they process it. When I first started this they did nothing like it in the states, but they’re doing the liposuction stuff now. I went to a doctor close by here and told him my story, and he was trying to sell his products so he was against my story, but I said, “You need to do a little more research, because what you’re saying isn’t true. I’m a true testament.”

After I talked to him and he fed me a big line of BS, and I said, “You don’t even know what you’re talking about. You do in a sense and you’re trying to sell your product, I understand that, but you’re not hitting the whole base, that’s for sure.”

Stem Cell Therapy for Cerebral Palsy – Sofia O.

My name is Maria, I’m Sofia’s mom, and this is my husband Sean, and that’s Sofia!

Sofia suffered a lack of oxygen at birth and has cerebral palsy because of it, so it’s a middle-grade injury.

We’ve been here last year for the stem cell treatment and she showed immediate improvement. Her circulation improved. She used to have purple toes and that stopped since the last treatment. Her vision improved. Her far-away vision last year, and this year she has reported to us that she has more sensation in the body, her hearing… like, last night we went out and she didn’t need the headphones. She was okay.

She wasn’t bothered by the noise from the traffic. She was much better, looser, and happier.

And definitely, she also reported that her vision improved even further. She was able to describe the colors of the cars, birds that she saw from the 24th floor.

And today, she says she doesn’t have pain in her arms and stomach anymore, so she feels looser and more comfortable.