Stem Cell Clinic

New Nanofiber Matrix Enhances Stem Cell Production – Drug Discovery & Development

By Embryonic Stem Cells

A new nanofiber-on-microfiber matrix could lead to more and better quality stem cells for disease treatment and regenerative therapies.

The matrix, produced by researchers from Kyoto University in Japan, is made of gelatin nanofibers on a synthetic polymer microfiber mesh and may provide a better way to culture large quantities of healthy human stem cells.

Researchers have been developing 3D culturing systems to allow human pluripotent stem cells (hPSC) to grow and interact with their surroundings in all three dimensions, as they would inside the human body, rather than in two dimensions like they do in a petri dish.

Pluripotent stems cells can differentiate into any type of adult cell and have potential for tissue regeneration therapies, treating diseases and for research.

The majority of 3D culturing systems have limitations and result in low quantities and quality of cultured cells.

The research team was able to fabricate gelatin nanofibers onto a microfiber sheet made of synthetic, biodegradable polyglycolic acid. They then seeded human embryonic stem cells onto the matrix in a cell culture medium.

The matrix allowed for an easy exchange of growth factors and supplements from the culture medium to the cells.

The stem cells also adhered well to the matrix, resulting in robust cell growth. After four days of culture more than 95 percent of the cells grew and formed colonies.

The research team also scaled up the process by designing a gas-permeable cell culture bag in which multiple cell-loaded, folded fiber-to-fiber matrices were placed.

The system was designed so that minimal changes were needed to the internal environment, which reduced the amount of stress placed on the cells. This also yielded a large number of cells compared to conventional 2D and 3D culture methods.

Our method offers an efficient way to expand hPSCs of high quality within a shorter term, the research team wrote in a statement. Additionally, as nanofiber matrices are advantageous for culturing other adherent cells, including hPSC-derived differentiated cells, FF matrix might be applicable to the large-scale production of differentiated functional cells for various applications.

According to the study, clinical-grade scaffolds and high-quality hPSCs are required for cell expansion as well as easy handling and manipulation of the products.

Current hPSC culture methods do not fulfill these requirements because of a lack of proper extracellular matrices (ECM) and cell culture wares.

The layered nano-on-micro fibrous cellular matrix mimicking ECM enables easy handling and manipulation of cultured cells.

The results show that the matrix supports effective hPSC culture with maintenance of their pluripotency and normal chromosomes over two months, as well as effective scaled-up expansion with fold increases of 54.115.6 and 40.48.4 in cell number per week for H1 human embryonic stem cells and 253G1 human induced pluripotent stem cells, respectively.

The study was published in Biomaterials.

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New Nanofiber Matrix Enhances Stem Cell Production - Drug Discovery & Development

How does the Catholic Church resolve new bioethical questions? – Catholic Free Press

By Embryonic Stem Cells

Father Tadeusz Pacholczyk

By Father Tadeusz Pacholczyk

A number of years ago, I participated in a debate at Harvard on embryonic stem cell research which also included a Jewish rabbi, an Episcopalian clergyman, and a Muslim imam. The debate went smoothly and cordially, although I was the only voice in the group who defended the human rights of individuals who happen still to be embryos. After the debate, the Episcopalian clergyman pulled me aside and told me how he thought Catholics should consider themselves fortunate to have such an authoritative reference point in the Church and the Vatican, particularly when it comes to resolving new bioethical questions. With surprising candor, he shared how he had sat on various committees with others from his own faith tradition where they had tried to sort through the ethics of embryonic stem cells, and he lamented, we just ended up discussing feelings and opinions, without any good way to arrive at conclusions.

Many people, indeed, appreciate that the Catholic Church holds firm and well-defined positions on moral questions, even if they may remain unsure about how or why the Church actually arrives at those positions, especially when it comes to unpacking new scientific developments like embryonic stem cell research.

So how does the Church arrive at its positions on bioethics? For one thing, it takes its time, and doesnt jump to conclusions even in the face of media pressure for quick sound bites and rapid-fire news stories.

I once had a discussion with a journalist for a major newspaper about the ethics of human-animal chimeras. He mentioned that a leading researcher working on chimeras had met the pope and afterwards implied that the pope had given his blessing to the project. I reminded him that its quite common for the pope to offer general encouragement and blessings to those he meets, though that wouldnt be the same thing as sanctioning new and morally controversial techniques in the biosciences. As a rule, the Catholic Church does not address important bioethical questions that way, through chance encounters with the pope as you are strolling through the hallways of the Vatican.

Instead, the Church may reflect for months, years, or even decades, to identify important considerations and guiding principles when new moral dilemmas arise in the biosciences. Even with this slow and deliberative process, I think its fair to say that the Church generally stays ahead of the curve. By the time of the successful cloning of Dolly the sheep in 1996, for example, the Catholic Church had already been reflecting on the question of human cloning for many years, and concluded, nine years prior to Dolly, that human cloning would be morally unacceptable in an important document called Donum Vitae (On the Gift of Life).

This same document also identified key moral problems with doing human embryonic stem cell research 11 years before it was even possible to destructively obtain those cells from human embryos. When the first test tube baby was born in 1978, the serious moral concerns raised by the procedure had already been spelled out twenty-two years earlier, by Pope Pius XII, in his 1956 Allocution to the Second World Congress on Fertility and Human Sterility wherein he concluded: As regards experiments of human artificial fecundation in vitro, let it be sufficient to observe that they must be rejected as immoral and absolutely unlawful.

Whenever definitive conclusions about medical ethics are reached or otherwise clarified by the Church, they are normally promulgated through official Church documents, like papal encyclicals and addresses, or, with the approval of the pope, documents and commentaries from the Congregation for the Doctrine of the Faith (CDF the Vatican office responsible for preserving and interpreting Catholic doctrine), or other congregations, councils or dicasteries of the Church.

Even today, certain bioethical controversies remain under active discussion within the Church, such as the question of whether it would be allowable to adopt abandoned frozen embryos by implanting and gestating them in volunteer mothers. While a 2007 CDF document expressed some reservations and concerns about the proposal, debate continues inside and outside the Vatican.

New medical discoveries and technological developments challenge us to careful moral reflection and discernment. These scientific developments can either be an opportunity for genuine human advancement or can lead to activities and policies that undermine human dignity. The U.S. Bishops in a recent document summed it up this way: In consultation with medical professionals, church leaders review these developments, judge them according to the principles of right reason and the ultimate standard of revealed truth, and offer authoritative teaching and guidance about the moral and pastoral responsibilities entailed by the Christian faith. While the Church cannot furnish a ready answer to every moral dilemma, there are many questions about which she provides normative guidance and direction.

Rev. Tadeusz Pacholczyk, Ph.D. earned his doctorate in neuroscience from Yale and did post-doctoral work at Harvard. He is a priest of the diocese of Fall River, MA, and serves as the Director of Education at The National Catholic Bioethics Center in Philadelphia. See http://www.ncbcenter.org

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How does the Catholic Church resolve new bioethical questions? - Catholic Free Press

Mayo researcher Abba Zubair is sending stem cells for study on the International Space Station – St. Augustine Record

By Uncategorized

As a boy growing up in Nigeria, Abba Zubair dreamed of becoming an astronaut.

But as he prepared to apply to college, an advisor told him to find a different path.

He said it may be a long time before Nigeria sends rockets and astronauts into space, so I should consider something more practical, Zubair saud.

He decided to become a physician, and is currently the medical and scientific director of the Cell Therapy Laboratory at the Mayo Clinic in Jacksonville. And while hell almost certainly never get to make a journey outside the Earths atmosphere, if the weather stays good Saturday hell be sending a payload into space.

A SpaceX Falcon 9 rocket is scheduled to launch at 10:01 a.m. Saturday from the Kennedy Space Center on a cargo delivery mission to the International Space Station. Among the cargo it will be carrying are several samples of donated adult stem cells from Zubairs research lab.

Zubair believes adult stem cells, extracted from bone marrow, are the future of regenerative medicine. Currently at the Mayo Clinic in Jacksonville they are being used in clinical trials to treat knee injuries and transplanted lungs.

But a big problem with using stem cells to treat illnesses is that it may require up to 200 million cells to treat a human being and the cells take a long time to reproduce. Based on studies using simulators on Earth, Zubair believes that the stem cells will more quickly mass produce in microgravity.

Thats the hypothesis hell be testing as the stem cells from his lab spend a month aboard the space station. Astronauts will conduct experiments measuring changes in the cells. They will then be returned on an unmanned rocket and Zubair will continue to study them.

Zubair became interested in the idea of sending stem cells into space four years ago, when he learned of a request for proposals that involved medicine and outer space. Hes been trying to arrange to send stem cells into space for three years.

In May 2015, he sent stem cells to the edge of space as a hot-air balloon carried a capsule filled with cells from his lab to about 100,000 feet then dropped the capsule. The idea was to test how the cells handled re-entry into the Earths atmosphere.

It turned out well, he said. The cells were alive and functioning.

Zubair was supported in that effort as he is being supported in sending cells to the space station by the Center for Applied Science Technology. Its chief executive is Lee Harvey, a retired Navy pilot and former astronaut candidate who lives in Orange Park.

While stem cells have myriad potential medical applications, one that particularly interests Zubair is the use of them in treating stroke patients. Its a personal cause to Zubair, whose mother died of a stroke in 1997.

Weve shown that an infusion of stem cells at the site of stroke improves the inflammation and also secretes factors for the regeneration of neurons and blood vessels, he said.

Zubair hasnt entirely given up on his old dream of being an astronaut. Hes applied for the civilian astronaut program. But he doesnt expect that to happen.

Im not sure I made a cut, he said. I just wanted to apply.

And he realizes what a long, strange trip hes made.

I have come so far from Africa to here, he said, and now Im sending stem cells into space.

Charlie Patton: (904) 359-4413

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Mayo researcher Abba Zubair is sending stem cells for study on the International Space Station - St. Augustine Record

Local vet taking part in stem cell therapy study for dogs – WPTV.com

By Uncategorized

TARPON SPRINGS, Fla. - Cosby just doesnt get around like he used to.

We have six dogs and hes always the one thats the last to get up. The last to get out, said his owner Brian Cirillo.

And for Cirillo, its sad to see.

I hate it. Its always like he always on his tippy topes on his back legs. So its heartbreaking.

But a new trial study that is about to start at the St. Francis Pet Care Center in Tarpon Springs, could be just what Cosby needs.

Veterinarian Mike Amsberry is offering stem cell therapy for dogs.

They are seeing that its very, very safe. And very effective.

This study is focused specifically on four-legged friends with arthritis.

But in the past hes seen stem cell treatments work wonders for other ailments.

Its cells treating the body, rather than then some foreign substance. Some medication.

In this trial, the stem cells come from umbilical cords of donor dogs.

Not only can qualified pets get the treatment for free, but owners are paid too.

Cosby seems like the perfect candidate.

I think thats where everything seems to be going with regard to medicine. So to be on the leading edge of that to potential help him without having to put him on a bunch of medicine is definitely a plus, said Cirillo.

The hope is one day Cosby will be able to keep up with the rest.

And lead the way to help thousands of other dogs.

For more information on the trial study go to petstemcells.org.

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Local vet taking part in stem cell therapy study for dogs - WPTV.com

Mesoblast’s cell therapy candidate MPC-300-IV shows positive effect in mid-stage study in treatment-resistant … – Seeking Alpha

By Uncategorized

A Phase 2 clinical trial assessing Mesoblast's (NASDAQ:MESO) allogeneic cell therapy candidate MPC-300-IV in patients with rheumatoid arthritis (RA) who have not responded to anti-Tumor Necrosis Factor (TNF) therapy [e.g., AbbVie's Humira (adalimumab)] showed a durable improvement in symptoms, physical function and disease activity with no safety signals observed.

The study enrolled 48 patients with active RA who were on a stable regimen of methotrexate and had an inadequate response to at least one anti-TNF agent. 63% (n=30/48) has received 1 - 2 biologic agents. Participants were randomized to receive a single infusion of 1MMesenchymal Precursor Cells(MPCs)/kg (n=16), 2M MPCs/kg (n=16) or placebo (n=16). The primary study period was 12 weeks and the total study duration was 52 weeks.

Both doses of MPC-300-IV outperformed placebo at both week 12 and week 39 as measured by ACR20/50/70 (ACR20 = 20% improvement in RA symptoms). The 2M-cell cohort showed the greatest response. At week 12, for example, 27% of the 2M-cell group achieved ACR70 compared to 0% for placebo. The proportion was 36% in the subgroup (n=11) who had received 1 - 2 biologics. The treatment effect was maintained through week 39.

The clinical development of MPC-300-IV is ongoing.

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Mesoblast's cell therapy candidate MPC-300-IV shows positive effect in mid-stage study in treatment-resistant ... - Seeking Alpha

Capricor Drops Cenderitide to Focus on Cell and Exosome Therapies – Genetic Engineering & Biotechnology News

By Uncategorized

Capricor Therapeutics is dropping further development of its Phase II-stage heart failure drug Cenderitide and is terminating its license agreement with the Mayo Clinic for the natriuretic peptide receptor agonist program. "Our decision to return these rights is a strategic move as we prioritize our efforts to advance our core cell and exosome-based therapeutic development programs," said Linda Marbn, Ph.D., Capricor president and CEO.

Capricor said it expects to reach key clinical milestones with both the cell and exome therapy programs during 2017. Topline data from the Phase I/II HOPE clinical study with lead cell therapy candidate CAP-1002 (allogeneic cardiosphere-derived cells) is expected during Q2 2017. The trial is evaluating CAP-1002 in patients with Duchenne muscular dystrophy (DMD)-associated heart disease. The firm said it is separately planning a clinical trial, anticipated to start during 2017, to investigate whether CAP-1002 therapy can boost skeletal muscle function in men and boys with DMD.

We are also committing increased attention to our exosomes program, and we expect to file an IND application for CAP-2003 (cardiosphere-derived cell exosomes) in the second half of this year," added Dr. Marbn. Capricor is developing CAP-2003 for the potential treatment of ophthalmic disorders, including ophthalmic graft-versus-host disease (oGvHD).

CAP-1002 is an allogeneic cardiac cell therapy product manufactured from donor heart tissue. The treatment has been granted orphan drug designation by the FDA for the treatment of DMD. Capricor and partner Janssen Biotech are developing a commercial manufacturing process for CAP-1002 as part of their potentially $337.5 million collaboration, established in January 2014, to develop the cell therapy program for cardiovascular applications. In May of last year, Capricor received a $3.8 million grant from the California Institute for Regenerative Medicine to support the Phase I/II HOPE study.

CAP-2003 exosomes are obtained from CAP-1002 cardiosphere-derived cells (CDCs). The exosome technology is being developed under a 2014 license agreement with the Cedars-Sinai Medical Center. In October 2016, Capricor was granted up to $4.2 million from the NIH to evaluate CAP-2003 exosome therapy for treating hypoplastic left heart syndrome. The previous month the firm received a $2.4 million grant from the U.S. Department of Defense to establish a commercial manufacturing platform for CAP-2003.

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Capricor Drops Cenderitide to Focus on Cell and Exosome Therapies - Genetic Engineering & Biotechnology News

Stem cell therapy treatment gives new lease of life to 5-year-old – Avenue Mail

By Uncategorized

Stem cell therapy treatment gives new lease of life to 5-year-old Jamshedpur February 17, 2017 , by Desk 104

Ranchi : Till very recently, it was believed that brain damage is irreversible. However, now with emerging research; we understand that it is possible to repair the damaged brain tissue using cell therapy.

Again, today there are still many people in India who have not preserved their stem cells through cord blood banks. For all those patients, who have lost their hopes in finding a new treatment for neurological related disorders, adult stem cell therapy offers a new hope for such kind of patients.

Dr Alok Sharma, Director, NeuroGen Brain and Spine Institute, Professor and Head of Neurosurgery, LTMG Hospital & LTM Medical College, Sion said Stem cell therapy is emerging as one of the newer treatment options for conditions like Autism, Cerebral Palsy, Mental retardation, Muscular Dytrophy, Spinal Cord Injury, Paralysis, Brain Stroke, Cerebellar Ataxia and Other Neurological Disorders. This treatment has the potential to repair the damaged neural tissue at molecular, structural and functional level.

Dr. NandiniGokulchandran, Deputy Director, Neurogen Brain and Spine Institute saidStem Cell Therapy (SCT) done at NeuroGen Brain and Spine Institute is a very simple and safe procedure. Stem Cells are taken from patients own bone marrow with the help of one needle and are injected back in their Spinal Fluid after processing.

Since they are taken from the patients own body there is no rejection, no side effects, hence making SCT a completely safe procedure.

Today, we are presenting a case study of Ranchi based 5 yrs old Master Dhairya Singh. He is a known case of brain damage due to lack of oxygen but not during birth. Dhairya was born in a normal manner, cried immediately after birth also his birth weight was appropriate.

There were no immediate post-natal complications reported. Dhariya was a normal child till the age of one and half years old. Then one day he suffered from an episode of pneumonia for which he was hospitalized for 6 days.

Last updated:Friday, February 17, 2017

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Stem cell therapy treatment gives new lease of life to 5-year-old - Avenue Mail

Takeda, TiGenix stem cell therapy shows sustained effect – FierceBiotech

By Stem Cell Treatment

Takeda and TiGenix have presented 52-week data on their allogeneic expanded adipose-derived stem cells in Crohns disease patients with treatment-refractory complex perianal fistulas. The data show the Cx601 stem cells continue to outperform placebo one year after administration.

TiGenix presented the 24-week data from the successful phase 3 trial back in 2015, sparking a surge in its stock price and setting it up to land a deal with Takeda. Last year it followed up with the release of a first look at 52-week results confirming the efficacy outcomes seen in the earlier data drop.

Takeda and TiGenix have now shared another overview of the 52-week data at the 12th Congress of the European Crohns and Colitis Organisation (ECCO). The abstract includes treatment-related adverse event data that were absent from TiGenixs original release, but included in subsequent presentations.

Those 52-week data confirm the positive safety profile seen in the 24-week results. The rate of treatment-emergent adverse events was lower in the Cx601 cohort than the placebo plus standard of care arm at both time points. The same is true when only serious adverse events are analyzed.

The safety results complement the previously-released efficacy data. Among the 62% of patients who completed the 52-week follow-up, the results were comparable to those generated after 24 weeks. In the Cx601 arm, 56.3% of the modified intention-to-treat (mITT) population achieved combined remission after 52 weeks, compared to 51.5% after 24 weeks. The respective figures for the placebo cohort are 38.6% and 35.6%. The mITT population included all patients to undergo at least one post-baseline efficacy evaluation.

These data highlight that the efficacy and safety of a single administration of Cx601 were maintained during one year of follow up, TiGenix CMO. Marie Paule Richard said in a statement. It is important to also note that the definition of combined remission used in the ADMIRE-CD study, which includes both clinical and radiological assessment by MRI, is more stringent than the criteria commonly used in previous large scale, randomized clinical trials evaluating perianal fistulas in Crohns disease, based only on clinical assessment.

Relapse rates in the Cx601 group were rarer, too. Three-quarters of participants who responded to Cx601 after 24 weeks made it to 52 weeks without relapsing. The number falls to 55.9% among the placebo cohort.

TiGenix is hoping the data will prove compelling enough to secure a regulatory approval in Europe later this year. In parallel, TiGenix is setting up another phase 3 trial designed to deliver data to support approval in the U.S.. TiGenix expects the trial to start later this year.

Shares in TiGenix traded up 4% shortly after the stock exchange in Brussels opened for the day.

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Takeda, TiGenix stem cell therapy shows sustained effect - FierceBiotech

A Breakthrough in Stem Cell Treatment? – Equities.com

By Stem Cell Treatment

Asterias Biotherapeutics (AST) continues to generate excitement and buzz around its stem cell treatment for catastrophic spinal cord injury (SCI). I wrote about this historic event back in September. Thats when the company first released results about this transformative medical breakthrough.

Asterias has now released follow-up data. This was gathered at six and nine months after six quadriplegics received treatment. All six continue to show improvement in motor function and sensation. This is truly wonderful news for those with SCI.

There are also broader medical implications and these should be of great interest to investors.

The difference between this stem cell therapy and traditional drug therapies is huge. Drug therapies have specific and mechanistic impacts. But stem cells derived from embryonic cells work a different way. They draw on the massive DNA databanks in their nuclei. They then use these genetic programs to interact with their surroundings and repair damaged structures.

The Asterias oligodendrocyte progenitor cells were derived from a single unused embryo (from an IVF procedure in the late 1990s). Such embryos are often discarded. But this one was donated to create an unlimited number of therapeutic cells. Both the Bush and Obama Administrations approved the cell line.

When injected into the site of a spinal cord injury, these cells create healthy new spinal cord structures. They restore myelin sheaths (which are like an insulating material on nerves) and repair the lesions caused by injury. They send chemical signals that stimulate the growth of nerve cells. They also generate blood vessels that deliver oxygen and nutrients (and clear out toxic substances).

In works of science fiction, you may have read about nanobots. These are theoretical nanomachines that can fix profound biological damage. But the truth is that we all have this type of device in our bodies at the embryonic stage of development. Each uses the complex repair systems that can be found in the human genome.

These are the cells (AST-OPC1) that were given to patients in the SCI trial. The result is that patients who could not breathe on their own can now perform complex physical tasks. We have seen them lift weights, text, and type 35 words a minute and they continue to improve.

Most people assume this therapy must be the most modern of biotechnologies. In truth, its quite old in modern scientific terms. Dr. Michael West oversaw the creation of this therapy over two decades ago as Gerons chief science officer.

When that company stumbled, he brought the clinical trial and Gerons IP into BioTime (*see disclosure below) as Asterias Biotherapeutics. When I spoke to Asterias CEO Steve Cartt, his excitement was palpable. Heres why.

Each year, about 17,000 people experience the kind of spinal cord injuries targeted by the current trial. AST-OPC1 would be the only approved treatment for this condition.

Cartt is now considering plans to extend clinical trials to those who have suffered less serious spinal cord injuries. This means the patient population for AST-OPC1 cells would expand a great deal.

These cells might also be used to treat other neurological diseases. Multiple sclerosis, for example, also involves the deterioration of the myelin nerve sheath. But this is just the tip of iceberg for pluripotent stem cell therapies. Many of our worst diseases can be addressed by these biological nanobots.

If spinal cords can be repaired, so can the connective tissue deterioration that leads to arthritis and joint failures. Im convinced we will see simple injections of stem cells to repair hip, knee, and other joints in the future.

BioTime has also done extensive research into stem cell therapies for heart muscle and cardiovascular repair. In fact, Dr. West has converted some of my cells to embryonic status. He then engineered them to become my heart muscle cells. There have been animal studies as well. The results indicate that these types of cells will repair the damage done by heart attacks.

Next up, though, is blindness. A BioTime subsidiary in Israel, Cell Cure Neurosciences, is in a phase 1/2a trial to treat dry age-related macular degeneration (dry-AMD). Israeli government grants have helped fund this project.

Based on animal trials, it seems that the companys retinal pigment epithelial cells will be successful in treating the leading cause of adult blindness. Dry-AMD is an attractive target because there is no effective treatment. From what Ive learned, I think that these cells will treat the wet form of macular degeneration and other causes of blindness as well.

This is the real importance of the Asterias SCI trial. Right now, were seeing the proof of concept for a biotechnology that will disrupt the entire healthcare market. I've written about this extensively in Tech Digest (subscribe here for free).

This change will happen sooner than you think. Japan has already revised its Pharmaceutical Affairs Act to speed up the approval of stem cell therapies. And on the home front, several of President Trump's candidates for FDA chief have endorsed similar reforms.

(*Disclosure: The editors or principals of Mauldin Economics have a position in BioTime (BTX) which has significant ownership of Asterias stock. They have no plans to sell their position at this time. There is an ethics policy in place that specifies subscribers must receive advance notice should the editors or principals intend to sell.)

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A Breakthrough in Stem Cell Treatment? - Equities.com

Orthopedic Stem Cell Research and Related Publications

By Stell Cell Research

Safety and Complications Reporting Update on the Re-implantation of Culture-Expanded MesenchymalStemCells using Autologous Platelet Lysate Technique.

Centeno CJ,Schultz JR,Cheever M,Freeman M,Faulkner S,Robinson B,Hanson R.CurrStemCell Res Ther. 2011 Oct 17.

The Centeno-Schultz Clinic, Broomfield, Colorado, USA.

Mesenchymalstemcells (MSCs) hold great promise as therapeutic agents in regenerative medicine. Numerous animal studies have documented the multipotency of MSCs, showing their capabilities for differentiating into orthopedic tissues such as muscle, bone, cartilage, and tendon. However, the safety of culture expanded MSCs for human use has only just begun to be reported. Methods: Between 2006 and 2010, two groups of patients were treated for various orthopedic conditions with culture-expanded, autologous, bone marrow-derived MSCs (group 1: n=50; group 2: n=290-one patient in both groups). Cells were cultured in monolayer culture flasks using an autologous platelet lysate technique and re-injected into peripheral joints or into intervertebral discs with use of c-arm fluoroscopy. While both groups had prospective surveillance for complications, Group 1 additionally underwent 3.0T MRI tracking of the re-implant sites. Results: The mean age of patients treated was 53 +/- 13.85 years; 214 were males and 125 females with mean follow-up time from any procedure being 435 days +/- 261 days. Number of contacts initiated based on time from first procedure was 482 at 3 months, 433 at 6 months, 316 contacts at 12 months, 110 contacts at 24 months, and 22 contacts at 36 months. For Group 1, 50 patients underwent 210 MRI surveillance procedures at 3 months, 6 months, 1 year and 2 years which failed to demonstrate any tumor formation at the re-implant sites. Formal disease surveillance for adverse events based on HHS criteria documented significantly less morbidity than is commonly reported for more invasive surgical procedures, all of which were either self-limited or were remedied with therapeutic measures. Two patients were diagnosed with cancer out of 339 patients treated since study inception; however, this was almost certainly unrelated to the MSC therapy and the neoplasm rate in similar to that seen in the U.S. Caucasian population. Knee outcome data was collected on a subset of patients. Here, >75% improvement was reported in 41.4% while decreasing the improvement threshold to >50% improvement, 63.2% reported an improvement. At an average reporting time of 11.3 months from first procedure average reported relief in the knee sample equaled 53.1% (n=133 reporting). Conclusions: Using both intensive high field MRI tracking and complications surveillance in 339 patients, no neoplastic complications were detected at anystemcell re-implantation site. These findings are consistent with our prior publication and other published reports that also show no evidence of malignant transformation in vivo, following implantation of MSCs for orthopedic use.

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Orthopedic Stem Cell Research and Related Publications

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