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New article concludes US FDA restrictions hampering stem cell therapy progress

FDA-NotApprovedStampAn article published this month in Thieme Journal of Knee Surgery entitled, “The Use of Biologic Agents in Athletes with Knee Injuries” concluded that “Biologic agents… are becoming the mainstay of nonoperative therapy in the high-demand athletic population.” but “…Unfortunately, strict regulations by the FDA continue to restrict their application in clinical practice.”

The good news is they also believe, “As the volume and quality of evidence continue to grow, biologic agents are poised to become an integral component of comprehensive patient care throughout all orthopedic specialties.”

The article is authored by Michaela Kopka and James P. Bradley from the Department of Orthopaedic Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania.

Abstract

Biologic agents are gaining popularity in the management of bony and soft tissue conditions about the knee. They are becoming the mainstay of nonoperative therapy in the high-demand athletic population.

The most well-studied agents include platelet-rich plasma (PRP) and stem cells—both of which have shown promise in the treatment of various conditions. Animal and clinical studies have demonstrated improved outcomes following PRP treatment in early osteoarthritis of the knee, as well as in chronic patellar tendinopathy. Early clinical evidence also lends support for PRP in the augmentation of anterior cruciate ligament (ACL) reconstruction. Research investigating the role of biologic agents in collateral ligament and meniscal injuries is ongoing.

Studies assessing the utility of stem cells have shown encouraging results in the setting of osteoarthritis.

Unfortunately, strict regulations by the FDA continue to restrict their application in clinical practice. A major limitation in the interpretation of current data is the significant variability in the harvesting and preparation of both PRP and stem cells.

As the volume and quality of evidence continue to grow, biologic agents are poised to become an integral component of comprehensive patient care throughout all orthopedic specialties.

View original here

First Duchenne’s Muscular Dystrophy Patient To Receive Umbilical Cord Stem Cell Therapy In US Turns 30

The first patient with Duchenne Muscular Dystrophy to be granted FDA approval for allogeneic adult stem cell therapy in the United States turned 30 this year, well surpassing his original life expectancy and paving the way for future patients, according to non-profit organization Coming Together For A Cure.

Duchenne Muscular Dystrophy Patient and Stem Cell Recipient, Ryan Benton

Ryan Benton

WICHITA, KANSAS (PRWEB) MAY 18, 2016 – Ryan Benton was diagnosed with Duchenne Muscular Dystrophy (DMD) at the age of three and given a life expectancy in the late teens to early twenties. DMD is a relatively common progressive genetic disorder, which causes aggressive deterioration of the muscles.

In 2009, at the age of 22, Benton’s condition was critical. He met with the founder of the Stem Cell Institute in Panama City, Panama and Medistem Panama, Neil H. Riordan, PhD. Research had shown that adult stem cell therapy might have the potential to reverse the progression of DMD.

Because of the laws restricting adult stem cell therapy in the United States, Benton was forced to travel to Panama to receive his first life-saving treatment. Ryan made seven trips to Panama to receive treatments from Dr. Riordan’s team of physicians at the Stem Cell Institute.

“Ryan has seen vast improvements in muscle mass and lung capacity as a result of his treatments…”

Ryan was assured at the start that there was no guarantee that we would find success but we knew it was his only hope in fighting the disease, especially since his health was at a critical point. Ryan could tell shortly after the first treatment that something was working. He found a renewed strength that he had never felt before and not once did he see any adverse side effects. He trusted Dr. Riordan and felt safe and eager to undergo additional treatments.

It took five years of hard work and successful treatments, but Benton became the first (and only) DMD patient granted FDA approval for this form of medical therapy inside the United States. An investigational new drug (IND) for compassionate use application was approved, allowing Benton to receive treatment in his hometown, Wichita, KS.

Approval from the FDA came with many stipulations, however. This form of treatment was to be used for only a single patient, twice a year for 3 years.

By all accounts, January 2016 was a major milestone. The FDA has recently granted an additional treatment per year, now allowing Ryan three total treatments per year, as well as approval for a second compassionate use IND for another patient. This second patient, a six-year-old boy, has also shown success from previous treatments in Panama. He received his first treatment in the United States this year .

Ryan and his family have been actively involved in the local muscular dystrophy community, and have personally known dozens of others with DMD who have passed away at far too young of an age. That number continues to grow each day, which only continues to frustrate Ryan and his family as they fight for this treatment to be more readily available for others suffering from the same disease. Ryan believes that if treated early enough, patients could have a strong chance to live a “normal” life. Ryan believes if he had been treated when he was six years old, it could be very likely that he would never have faced any of the diseases debilitating effects.

Ryan has seen vast improvements in muscle mass and lung capacity as a result of his treatments, but we believe additional treatments on a more frequent basis would help ensure maximum potential when it comes to reversing the progression of his disease. Immediately following each round of treatment, we see dramatic increases in his overall health, stamina, physical strength, and ease in ability to breathe. Unfortunately, we have found that on average, three to four months after each treatment, the effectiveness of the cells begins to decrease. We believe the FDA’s permission to increase the number of treatments per year will help safeguard Ryan’s ability to preserve his improvements and more effectively control his Duchenne’s Muscular Dystrophy. Video: Ryan Benton discusses stem cell therapy for DMD
For many families that have lived alongside, or suffered from this disease, this is very exciting news. Ryan and his family are continually heart stricken as they hear of another member of their md community has died far too young due to the disease. It’s their hope they can help provide other families the same opportunities that they were so fortunate to receive.

Coming Together for a Cure, (CTFAC) is a non-profit organization founded by Benton’s siblings, Lauren and Blake after Ryan’s first round of treatments in 2009. In the 7 years since the Bentons were given new hope, they’ve been hard at work raising awareness and support for adult stem cell research and therapy.

To find more information about their organization, their family, or to find out how you can help, please visit http://www.comingtogetherforacure.org

For all other inquiries, please email comingtogetherforacure(at)gmail(dot)com

Dr. McKenna of Riordan-McKenna Institute teaches at an orthopedic surgery conference in Milan, Italy.

From Facebook: Busy week that ended with me doing surgery teaching at the Largest shoulder course in Europe. The Spalla Shoulder course in Milan Italy . My talk and surgery demonstration video was the first scheduled lecture after lunch. 2 PM Italian time which meant 7am Texas time!!! This was the first surgical demonstration of the Hemicap partial shoulder replacement technique that I just got published in Decembers journal of shoulder and elbow surgery.

The first picture is me In front of the cameras and my computer giving the lecture in Milan live from my kitchen table. The second picture is from the lecture hall in Milan from the crowds perspective. Thank you Mike Mitchell and Shannon for setting this up where I could still give my talk and not have to leave the country at such a crucial time for RMI…Live surgery Demonstration broadcast to the Spalla shoulder and elbow course in Milan Italy. Thanks to Dr Castagna for the invitation and opportunity to share our new technique with orthopedic surgeons from all over the world.

Dr. R Wade Mckenna addresses a medical conference in Milan, Italy. Dr. McKenna is partners with Dr. Riordan at the Riordan-McKenna Institute of Regenerative Medicine for Orthopedics in Southlake, Texas.

Posted by The Stem Cell Institute on Monday, February 15, 2016

2016-02-15T19:50:05+00:00 February 15th, 2016|Dr. Wade McKenna, News, Riordan-McKenna Institute, Shoulder Surgery|

Modulation of Cytokines in Cancer Patients by Intravenous Ascorbate Therapy

IV-Vitamin-CNina Mikirova, Neil Riordan, Joseph Casciari

Med Sci Monit 2016; 22:14-25
DOI: 10.12659/MSM.895368

BACKGROUND: Cytokines play an important role in tumor angiogenesis and inflammation. There is evidence in the literature that high doses of ascorbate can reduce inflammatory cytokine levels in cancer patients. The objective of this study was to investigate the effect of treatment by intravenous vitamin C (IVC) on cytokines and tumor markers.

MATERIAL AND METHODS: With the availability of protein array kits allowing assessment of many cytokines in a single sample, we measured 174 cytokines and additional 54 proteins and tumor markers in 12 cancer patients before and after a series of IVC treatments.

RESULTS: Presented results show for our 12 patients the effect of treatment resulted in normalization of many cytokine levels. Cytokines that were most consistently elevated prior to treatments included M-CSF-R, Leptin, EGF, FGF-6, TNF-α, β, TARC, MCP-1,4, MIP, IL-4, 10, IL-4, and TGF-β. Cytokine levels tended to decrease during the course of treatment. These include mitogens (EGF, Fit-3 ligand, HGF, IGF-1, IL-21R) and chemo-attractants (CTAC, Eotaxin, E-selectin, Lymphotactin, MIP-1, MCP-1, TARC, SDF-1), as well as inflammation and angiogenesis factors (FGF-6, IL-1β, TGF-1).

CONCLUSIONS: We are able to show that average z-scores for several inflammatory and angiogenesis promoting cytokines are positive, indicating that they are higher than averages for healthy controls, and that their levels decreased over the course of treatment. In addition, serum concentrations of tumor markers decreased during the time period of IVC treatment and there were reductions in cMyc and Ras, 2 proteins implicated in being upregulated in cancer.

Read Full Article…

2016-02-15T17:06:37+00:00 February 15th, 2016|Cancer, Neil Riordan, News, PhD|

“Best decision I ever made” – Tati Ali about stem cell therapy for multiple sclerosis and rheumatoid arthritis

Tati Ali RA and MS

I went to Panama City, Panama and received 92.4 million Umbilical Cord Stem Cells to treat my Multiple Sclerosis, Rheumatoid Arthritis, and osteoarthritis. Best decision I’ve ever made. Before Umbilical Cord Stem Cells, I spent every single night crying in pain. I was depressed for several years. I was planning my own death before I reached 30 years of age. I’m only 26 years old. Now, I was a given a new chance because stem cells. Everyone around me knows I’ve changed. It has been 3 months since treatment. Now, I strength train. I’ve had Juvenile RA my entire life and MS for 6 years. – Tati Ali

Stem cells “make her feel happy” – Stem Cell Therapy for Autism

Stem-Cell-Therapy-for-Autism-IconFor anyone with reservations about what the Stem cell Institute / stem cells can do, I have an 8 year old daughter that received her first Treatment 6 months ago. Prior to treatment she could speak but her speech was generally limited to asking for basic needs, and being trapped in cartoon dialogue for hours at a time. She would only eat a very limited few foods, she was generally unaware of others, didn’t express feelings or emotions, she was fearful to try doing new things, she had many sensory issues.

Within days of receiving her first treatment, she started asking us complex questions and we had real dialogue exchanges. She started venturing outside her comfort zone and trying new things like going on boat, kayak, tubing, etc. (none of which she would do prior). She started branching out and trying new foods, and at this point tries new things to determine how they taste and feel. She has become very social and has made friends at school, even though she has significant social delays and doesn’t always understand how play and interaction should happen, she tries and wants to play with others.

The most impressive change is that she is now much more connected to her surroundings and to events happening around her. She is also now capable of expressing feelings and emotions in an appropriate way. Prior to stem cells she could Say I love you, but it was in the same tone and voice inflection that was said to her. Now it’s her voice on her terms.

We just came back from a second treatment and are hopeful for more healing. We still have a ways to go, but are so happy with how much progress she has made.

Additionally I want to add that she looks forward to the treatments, she asks if she gets to get stem cells. In her words, she says, “they make her feel happy.” – Loreea Gallagher

2016-02-12T16:35:24+00:00 February 12th, 2016|Autism, Autism, mesenchymal stem cells, News, Patient Stories, Stem Cell Therapy|

Stem Cell Treatments for Autism – Danny Briones

Danny Briones discusses his son’s improvements following *umbilical cord tissue-derived mesenchymal stem cell treatments at the Stem Cell Institute in Panama.

For more information about autism treatment in Panama, please visit: https://www.cellmedicine.com/stem-cell-therapy-for-autism/

*umbilical cord tissue is donated after normal, healthy births

Stem Cell Therapy for Knee Pain and Injuries – Teresa Hamrick’s Story

Registered Nurse and Stem Cell Recipient, Teresa Hamrick tells her uplifting story about how bone marrow stem cell therapy augmented with AlphaGEMS amniotic tissue product got her out of a wheelchair. Teresa received her treatments at the Riordan-McKenna Institute (RMI) in Southlake, Texas. RMI is Dr. Riordan’s new orthopedic stem cell clinic. For more information, please visit: www.rmiclinic.com

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