A Panamanian-led, multidisciplinary research team has published the first description of non-expanded fat stem cells in the treatment of rheumatoid arthritis patients. “Autologous Stromal Vascular Fraction Therapy for Rheumatoid Arthritis: Rationale and Clinical Safety,” which appears in the January publication of the International Archives of Medicine, followed 13 rheumatoid arthritis patients who were treated with their own fat-derived stem cells.

Treating arthritis with fat-derived stem cells has become commonplace in veterinary medicine over the past five years with over 7,000 horses and dogs treated by publication contributor Vet-Stem, a San Diego-based company. The objective of the joint Panamanian-US study was to determine feasibility of translating Vet-Stem’s successful animal results into human patients.

Observing no treatment associated adverse reactions after one year, the team concluded that its protocol should be studied further to determine efficacy in the treatment of rheumatoid arthritis. Their publication details the rationale for the use of fat derived stem cells in treatment of autoimmune conditions and is freely available at: http://www.intarchmed.com/content/pdf/1755-7682-5-5.pdf

“Key to advancement of any medical protocol is transparent disclosure of rationale, treatment procedures and outcomes to the research community in a peer-reviewed and IRB-compliant manner,” said Dr. Jorge Paz Rodriguez, Medical Director of the Stem Cell Institute and research team leader. “While we have previously published case studies on the use of fat stem cells in multiple sclerosis patients, and one rheumatoid arthritis patient, this is the first time that comprehensive follow-up has been completed for a larger cohort of patients,” he added.

An important distinction that separates this particular approach from those which are being explored by several international investigators is that the fat stem cells were not grown in a laboratory, affording a substantially higher level of safety and protocol practicality.

“This work signifies Panama’s emergence into the burgeoning field of translational medicine,” commented Dr. Ruben Berrocal Timmons, the Panamanian Secretary of Science and publication co-author. “We are proud to have attracted and collaborated with internationally-renowned stem cell clinical researchers such as Dr. Michael Murphy and Dr. Keith March from the Indiana University School of Medicine Center for Vascular Biology and Medicine, Dr. Boris Minev from the University of California, San Diego Moores Cancer Center, Dr. Chien Shing Chen from Loma Linda University Behavioral Medicine Center and Dr. Bob Harman from Vet-Stem. By leveraging their vast, collective clinical experience with Panamanian scientific infrastructure and know-how, we are striving to develop effective, internationally recognized stem cell procedures that will be accepted the world over.”

The treatment procedure involves a mini-liposuction, collection of the fat’s cellular component, processing to obtain a population of cells that includes stem cells, freezing the cells in preparation for quality control, and subsequent re-administration of the cells into patients.

The Panamanian-US group has previously shown that there is a specific type of T cell, called the T regulatory cell, associated with fat stem cells, which is capable of suppressing pathological immunity. Their current theory, which is described in detail in the publication: http://www.ncbi.nlm.nih.gov/pubmed/20537320, is that the T regulatory component of the fat is capable of slowing down or suppressing the “autoimmune” reaction, while the stem cell component causes formation of new tissue to replace the damaged joints.

About the Stem Cell Institute
Founded in 2006 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, the institute’s doctors treat carefully selected patients with spinal cord injury, osteoarthritis, heart disease, multiple sclerosis, rheumatoid arthritis and other autoimmune diseases. Doctors at The Stem Cell Institute have treated over 1000 patients to-date.

For more information on stem cell therapy:

Stem Cell Institute Web Site: http://www.cellmedicine.com
Facebook: http://www.facebook.com/stemcellinstitute
Blogger: http://www.adult-stem-cell-therapy.blogspot.com

Stem Cell Institute
Via Israel & Calle 66
Pacifica Plaza Office #2A
San Francisco, Panama
Republic of 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)

Paz Rodriguez J, Murphy MP, Hong S, Madrigal M, March KL, Minev B, Harman RJ, Chen CS, Timmons RB, Marleau AM, Riordan NH.

ABSTRACT: Advancements in rheumatoid arthritis (RA) treatment protocols and introduction of targeted biological therapies have markedly improved patient outcomes, despite this, up to 50% of patients still fail to achieve a significant clinical response. In veterinary medicine, stem cell therapy in the form of autologous stromal vascular fraction (SVF) is an accepted therapeutic modality for degenerative conditions with 80% improvement and no serious treatment associated adverse events reported. Clinical translation of SVF therapy relies on confirmation of veterinary findings in targeted patient populations. Here we describe the rationale and preclinical data supporting the use of autologous SVF in treatment of RA, as well as provide 1, 3, 6, and 13 month safety outcomes in 13 RA patients treated with this approach.

PMID: 22313603 [PubMed - as supplied by publisher]

FULL TEXT: http://www.intarchmed.com/content/pdf/1755-7682-5-5.pdf

Stem Cell Recipient Marian D'unger and Patient Relationship Coordinator Melisa Cristaldi

The right side of my body was affected the worst. I was experiencing difficulty at times holding a fork or a pen. I started taking Celebrex and increased the number of aspirin I was taking daily. Around the first part of 2010 the rheumatologist I was seeing prescribed methotrexate again, but this time in injectable form. The effects were horrible. It was as if I injected myself with food poisoning every Monday evening. I was very sick and unable to work for two days after the shot.

A friend of mine in Corpus Christi, Maryanne Sinclair, contacted me in June and told me the story of a gentleman who had gone to Panama for stem cell therapy. His name is Dusty Durrill. She said the results of the treatment were a miracle for him. He told friends and anyone who would listen about the clinic. My friends said the changes in him were indeed amazing. He was able to walk without assistance, the swelling in his hands and feet had gone down drastically. He flew the head of the clinic to Corpus Christi in June to speak to the people who were wanting more information about the treatments there. I was one of the approximately 200 people who attended the meeting. Dusty Durrell had checked out the clinics in Israel and Germany. There was a clinic at that time also in Costa Rica which has now closed.

I was at that point taking two Celebrex per day and ten to 12 aspirin, and I felt terrible most of time. I applied based on his experience, and arrived in Panama on August 28th.

The following is my testimonial for the Stem Cell Institute

The Stem Cell Institute offers me hope for a pain-free life. I flew to Panama the end of August, 2010 for a two-week stay and treatment for Rheumatoid Arthritis. I was most impressed with their facilities, personnel, and administrative support which are an adjunct to the treatment regimen associated with the patient care. The medical staff exhibits a degree of care which exceeded my expectations. To date, I have experienced positive results from the stem-cell infusions with no adverse reaction. I am continuing to improve which is an apparent result of my treatment.

I am delighted to speak with your prospective patients that want to speak to someone who has been through the Stem Cell Institute.

Sincerely,

Marian D’Unger

FROM: THESPECTRUM.COM

Gaining Strength

CEDAR CITY – Jarom Hlebasko, a Cedar City man who suffered a spinal cord injury more than 10 years ago while playing in the snow, has been working hard in physical therapy to gain strength after receiving stem cell treatments in Panama in October 2011.

Following his trip to Panama City, Hlebasko, who seeks to regain the use of his arms and legs, said he has seen noticeable improvement in his physical condition, which he attributed to physical therapy and the stem cell treatments that involved removing stem cells from his body and using them to treat his spinal cord.

One of the improvements he has noticed is that he is able to work out for longer periods of time. He said he is also experiencing sensation in parts of his body that were once numb, especially when he exerts muscles while working out.

He said he has been told that patients with spinal cord injuries generally need more than one round of stem cell treatment. He said he hopes to be able to go back to Panama for additional treatment in the future. Future treatments, he said, would not be as expensive or as lengthy as the first one, during which he remained in Panama for a month. He said medical professionals at the Stem Cell Institute in Panama City have already extracted stem cells from his hip that have not yet been used.

While Hlebasko has received assistance from community fundraising efforts, he said he does not want to ask the Iron County community for any more money to pay for his stem cell treatments. However, his foundation, which is called Hope for the Change, is preparing a fundraising event to help a resident of Cedar City or the surrounding area to receive needed medical treatment.

“We’ve already started the ball rolling with (selecting) another applicant,” he said.

His wife, Leslie Hlebasko, said anyone who would like to apply to be the beneficiary of the fundraiser can go to the Hope for the Change Foundation’s website, www.hopeforthechange.com, to learn about the requirements for applying.

“It’s for any kind of medical need that isn’t covered by your insurance,” she said.

She said an impartial committee will select this year’s beneficiary.

Jarom Hlebasko said applicants who are not chosen to benefit from this year’s fundraiser will have the opportunity to try again next year.

“We’re hoping the community will realize that this is an annual event,” Leslie Hlebasko said.

Aided by financial assistance that allowed him to receive stem cell treatments, Jarom Hlebasko said the quality of his life has noticeably improved. He said he feels stronger than he did before the treatments.

“It just takes time,” he said.

Tyler Brinkerhoff, a physical therapist with Southern Utah Physical Therapy, said he worked with Jarom Hlebasko before and after the stem cell treatments.

Brinkerhoff said he has seen Jarom Hlebasko gain more muscle mass and balance.

“The thing that I think that has been good about Jarom is that he’s worked really hard.” Brinkerhoff said.

Dena Cloward, a friend of the family, said she has also noticed that Jarom Hlebasko has gained muscle.

“I’ve definitely seen positive changes in him, which is so exciting,” she said.

Cloward is working with the Hlebaskos to organize this year’s fundraiser. Organizers have yet to announce the date and location of the fundraiser.

Osanai, Toshiya MD, PhD*; Kuroda, Satoshi MD, PhD*; Sugiyama, Taku MD, PhD*; Kawabori, Masahito MD*; Ito, Masaki MD*; Shichinohe, Hideo MD, PhD*; Kuge, Yuji PhD‡; Houkin, Kiyohiro MD, PhD*; Tamaki, Nagara MD, PhD‡; Iwasaki, Yoshinobu MD, PhD*

Abstract

BACKGROUND: A noninvasive and effective route of cell delivery should be established to yield maximal therapeutic effects for central nervous system (CNS) disorders.

OBJECTIVE: To elucidate whether intra-arterial delivery of bone marrow stromal cells (BMSCs) significantly promotes functional recovery in traumatic brain injury (TBI) in rats.

METHODS: Rat BMSCs were transplanted through the ipsilateral internal carotid artery 7 days after the onset of cortical freezing injury. The BMSCs were labeled with fluorescent dye, and in vivo optical imaging was employed to monitor the behaviors of cells for 4 weeks after transplantation. Motor function was assessed for 4 weeks, and the transplanted BMSCs were examined using immunohistochemistry.

RESULTS: In vivo optical imaging and histologic analysis clearly demonstrated that the intra-arterially injected BMSCs were engrafted during the first pass without systemic circulation, and the transplanted BMSCs started to migrate from the cerebral capillary bed to the injured CNS tissue within 3 hours. Intra-arterial BMSC transplantation significantly promoted functional recovery after cortical freezing injury. A subgroup of BMSCs expressed the phenotypes of neurons, astrocytes, and endothelial cells around the injured neocortex 4 weeks after transplantation.

CONCLUSION: Intra-arterial transplantation may be a valuable option for prompt, noninvasive delivery of BMSCs to the injured CNS tissue, enhancing functional recovery after TBI. In vivo optical imaging may provide important information on the intracerebral behaviors of donor cells by noninvasive, serial visualization.

One hundred and twenty subacute ischemic stroke patients were treated with mononuclear bone marrow-derived stem cells. Patients ranged in age from eighteen to seventy five years old. All were treated within seven to thirty days of suffering their strokes. Each patient was assessed using the Barthel index. The results showed that seventy three percent of patients who were treated with stem cells attained a Barthel score of greater than or equal to 60, which is the measure for assisted independence. Only sixty one percent of the patients who were not treated with stem cells achieved similar scores. All patients were tumor free at one year. This study was performed by Kameshwar Prasad, M.B.B.S., M.D., from the All India Institute of Medical Sciences in New Delhi.

In a separate study from the All India Institute of Medical Sciences in New Delhi, Rohit Bhatia, M.D. examined autologous mononuclear mesenchymal stem cell therapy in forty stroke patients who were recruited for the study from three months to one year after their strokes. Patients who were treated with stem cells showed significant improvement based on the Barthel index. No adverse reactions were observed. Dr. Bhatia concluded that intravenous administration of mononuclear and mesenchymal stem cells is safe, feasible and likely facilitates behavioral recovery following stroke.

Department of Clinical Neurosciences, University of Cambridge, Cambridge, UK.

Abstract

BACKGROUND:
More than half of patients with multiple sclerosis have progressive disease characterised by accumulating disability. The absence of treatments for progressive multiple sclerosis represents a major unmet clinical need. On the basis of evidence that mesenchymal stem cells have a beneficial effect in acute and chronic animal models of multiple sclerosis, we aimed to assess the safety and efficacy of these cells as a potential neuroprotective treatment for secondary progressive multiple sclerosis.

METHODS:
Patients with secondary progressive multiple sclerosis involving the visual pathways (expanded disability status score 5·5-6·5) were recruited from the East Anglia and north London regions of the UK. Participants received intravenous infusion of autologous bone-marrow-derived mesenchymal stem cells in this open-label study. Our primary objective was to assess feasibility and safety; we compared adverse events from up to 20 months before treatment until up to 10 months after the infusion. As a secondary objective, we chose efficacy outcomes to assess the anterior visual pathway as a model of wider disease. Masked endpoint analyses was used for electrophysiological and selected imaging outcomes. We used piecewise linear mixed models to assess the change in gradients over time at the point of intervention. This trial is registered with ClinicalTrials.gov, number NCT00395200.

FINDINGS:
We isolated, expanded, characterised, and administered mesenchymal stem cells in ten patients. The mean dose was 1·6×10(6) cells per kg bodyweight (range 1·1-2·0). One patient developed a transient rash shortly after treatment; two patients had self-limiting bacterial infections 3-4 weeks after treatment. We did not identify any serious adverse events. We noted improvement after treatment in visual acuity (difference in monthly rates of change -0·02 logMAR units, 95% CI -0·03 to -0·01; p=0·003) and visual evoked response latency (-1·33 ms, -2·44 to -0·21; p=0·020), with an increase in optic nerve area (difference in monthly rates of change 0·13 mm(2), 0·04 to 0·22; p=0·006). We did not identify any significant effects on colour vision, visual fields, macular volume, retinal nerve fibre layer thickness, or optic nerve magnetisation transfer ratio.

INTERPRETATION:
Autologous mesenchymal stem cells were safely given to patients with secondary progressive multiple sclerosis in our study. The evidence of structural, functional, and physiological improvement after treatment in some visual endpoints is suggestive of neuroprotection.

FUNDING:
Medical Research Council, Multiple Sclerosis Society of Great Britain and Northern Ireland, Evelyn Trust, NHS National Institute for Health Research, Cambridge and UCLH Biomedical Research Centres, Wellcome Trust, Raymond and Beverly Sackler Foundation, and Sir David and Isobel Walker Trust.

Dr. Janet Vaughan and Professional 10-Dance World Champion Eddie Stutts

From 2007-2009, Dr. Vaughan partnered with World Champion Tony Dovolani and competed extensively in the U.S., winning a National Reserve Pro/Am Rhythm title. Tony Dovolani is best known for his appearances on ABC’s hit reality series, “Dancing with the Stars”, and has teamed up with Chynna Phillips, Wendy Williams, Audrina Partridge, Kate Gosselin, Kathy Ireland, Susan Lucci, Jane Seymour and other celebrities on the show.

Dr. Vaughan and Mr. Stutts are slated to compete in the Heritage Classic Dancesport Championships in Asheville, North Carolina next month. This will be the first time Dr. Vaughan has been able to compete since 2010 when she sustained a dancing related knee injury.

Dr. Vaughan also suffered from chronic neck pain resulting from injuries sustained in a car crash twenty years ago. Her neck injury culminated in a natural fusion of the c5-c6 vertebrae, scoliosis and extreme pain when her neck slipped out of alignment.

In an attempt to repair her knee and get her dancing career back on track, Dr. Vaughan decided to undergo stem cell therapy at the Stem Cell Institute in Panama City, Panama. “I was basically removed from competitive dance work because I could not rise or squat without extreme pain. I had also resigned myself to enduring chronic neck pain from my past accident and painful hand joints due to generalized arthritis,” said Dr. Vaughan.

Dr. Janet Vaughan and "Dancing with the Stars" Tony Dovolani

The fat tissue sample is collected via mini-liposuction, which is performed by a certified plastic surgeon under light, general anesthesia. Mesenchymal stem cells and T regulatory cells reside within this tissue.

Adipose-derived cells are then separated from the fat at Medistem Panama’s state-of-the-art laboratory at the prestigious City of Knowledge. This entire process is subjected to stringent quality control. Before they can be administered back into the patient, these adipose-derived stem cells are tested for quality, bacterial contamination (aerobic and anaerobic) and endotoxin.

All patients treated with adipose stem cells at the Stem Cell Institute wait about one week before the stem cells can be re-implanted to minimize the probability of the cells migrating back to the liposuction injury site. This essential procedural step separates treatment in Panama from “same-day” protocols offered elsewhere.

The adipose-derived stem cells are administered by a highly-qualified physician into the affected joint(s) (intra-articular injection) and intravenously (IV).

“It’s taken about 6 months but I am amazed at the results I’ve gotten with my knee. Even my neck is better. I used to spend almost $1,000 per month on a neuromuscular massage therapist but I haven’t needed any neuromuscular massages for the past 6 months. I wasn’t counting on that. Even my doctors say that the dense scar tissue in my neck has changed in texture from grizzly to smooth, supple tissue,” exclaimed Dr. Vaughan.

She continued, “I just danced 6 hours in Houston preparing for the upcoming competition in Asheville and my knee isn’t even sore.”

Dr. Vaughan is planning to return to Panama for a follow-up treatment this summer

Fat stem cells and bone marrow stem cells were grown on surfaces with different degrees of hardness ranging from very hard bone-like surfaces to very soft brain tissue-like surfaces.

The researchers found that the fat derived stem cells were much more likely (up to fifty times) to exhibit proteins that are essential to the cells becoming muscle tissue.
Yuk Suk Choi, a post-doc team member, says that the fat-derived stem cells seem to proliferate better than bone marrow cells when introduced to the hard surfaces. “They are actively feeling their environment soon, which allows them to interpret the signals from the interaction of cell and environment that guide development,” explained Choi.

Unlike bone marrow stem cells, stem cells from fat fused together to form myotubes. Although this phenomenon has been observed in the past, it has never been observed at such a high degree by Engler in the lab. Myotubes comprise an essential step in muscle formation.

Next, Engler and his team plan to observe how fused cells from fat perform in lab mice which are afflicted with a particular form of muscular dystrophy.
However, Dr. Engler cautioned, “From the perspective of translating this into a clinically viable therapy, we want to know what components of the environment provide the most important cues for these cells.”