Creative Medical Technology Holdings Appoints Internationally Renowned Stem Cell Pioneer as Chief Scientific Officer – Yahoo Finance

SAN DIEGO and PHOENIX, March 8, 2017 /PRNewswire/ --Creative Medical Technology Holdings, Inc. (CELZ) announced today the appointment of Dr. Thomas Ichim to the position of Chief Scientific Officer. Dr. Ichim will lead development of the Company's clinical stage CaverStemTM personalized stem cell therapy for erectile dysfunction, as well as advance preclinical and eventually clinical studies on the Company's universal donor AmnioStemTM stem cell therapy for post-stroke recovery.

"It is my honor to welcome Dr. Ichim to the position of Chief Scientific Officer," said Timothy Warbington, President and CEO of CELZ. "I have known Dr. Ichim for more than 10 years and have witnessed him grow his previous company, Medistem Inc., from concept to FDA Investigational New Drug (IND) clearance, to eventual acquisition by the NYSE traded company Intrexon. I am confident that Dr. Ichim will put CELZ on the same trajectory of success."

"Having published 20 peer-reviewed papers with Dr. Ichim over the last nine years, I greatly respect his unique ability to rapidly accelerate progress from concept, to patent, product. I look forward to continuing our collaborations in his new position," said Dr. Amit Patel, Cofounder and Board Member of CELZ, and Head of Cardiac Surgery at University of Miami.

"Dr. Ichim represents a true visionary in the area of cellular therapy, being one of the few people that effectively combines deep knowledge of basic science, regulatory affairs, and clinical translation. I plan to leverage our existing strengths at the Pacific Neurosciences Institute and at St John Providence to accelerate neurological uses of the Company's AmnioStemTM stem cell, particularly in the indication of post-stroke recovery," said Dr. Santosh Kesari, MD, PhD, FANA, FAAN, Scientific Advisory Board Member of CELZ. Dr. Kesari is Chair and Professor, Department of Translational Neurosciences and Neurotherapeutics, John Wayne Cancer Institute, as well as Director of Neuro-oncology, Providence Saint John's Health Center and leads the Pacific Neuroscience Research Center at Pacific Neuroscience Institute.

"I am enthusiastic about working with the distinguished team that Mr. Warbington assembled to accelerate clinical development of the Company's products," said Dr. Thomas Ichim, Ph.D. "This is one of those few occasions when one finds themselves in a position to work with people that one respects both as individuals and as leaders in their fields."

Dr. Ichim has extensive experience with stem cell therapy and cellular product development through FDA regulatory pathways. Dr. Ichim spent over seven years as the Chief Executive Officer, and subsequently, President and Chief Scientific Officer of Medistem, developing and commercializing a novel stem cell, the Endometrial Regenerative Cell, through drug discovery, optimization, preclinical testing, IND filing, and up through Phase II clinical trials with the FDA. Subsequent to the acquisition of Medistem by Intrexon, in a deal worth $26 million, Dr. Ichim was brought on to the parent company in its cell engineering unit as Vice President of Cellular Therapy. Dr. Ichim has over 100 patents and patent applications, as well as 103 peer reviewed publication.

About Creative Medical Technology Holdings

Creative Medical Technology Holdings, Inc. is a clinical stage biotechnology company currently trading on the OTCQB under the ticker symbol CELZ. For further information about the company go to http://www.creativemedicaltechnology.com.

Forward-Looking Statements

OTC Markets has not reviewed and does not accept responsibility for the adequacy or accuracy of this release. This news release may contain forward-looking statements including but not limited to comments regarding the timing and content of upcoming clinical trials, marketing efforts, funding, etc. Forward-looking statements address future events and conditions and, therefore, involve inherent risks and uncertainties. Actual results may differ materially from those currently anticipated in such statements. See the periodic and other reports filed by Creative Medical Technology Holdings, Inc. with the Securities and Exchange Commission and available on the Commission's website at http://www.sec.gov.

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Creative Medical Technology Holdings Appoints Internationally Renowned Stem Cell Pioneer as Chief Scientific Officer - Yahoo Finance

Regenerative therapy is new frontier in injury recovery – TCPalm

Fran Foster, The Newsweekly 1:01 a.m. ET March 8, 2017

Regenerative Biologics Institute (RBI) Managing Director Jason Griffeth in the procedure room where he performs advanced regenerative medicine treatments. He has been studying the science of stem cells for nearly 20 years.(Photo: Fran Foster)

Whenever their bodies are ailing, people usually look for a magical solution or an easy-to-swallow pill to make things better. Turns out, in some situations, that sought-for remedy may be in your own fat cells.

Beth Darraugh, 50, lives here in Vero Beach as well as in New York City. She has been active all of her life from volleyball in her youth to walking along the beach in Mexico. Shes experienced plenty of aches and pains but, as she has gotten older, she realized she wasnt recovering as quickly.

I had already had some orthopedic problems with my knee and was told I was probably going to have to succumb to surgery, she says. I wasnt ready for that and started researching about other techniques. While in Mexico, walking with my mom, something didnt feel right and I knew I had to do something. (Living) part time in New York City requires a lot of walking and it was getting harder and harder.

This is where Regenerative Biologics Institute, located here in Vero Beach, entered Darraughs life. RBI provides an option for treating orthopedic conditions and pain besides pills, cortisone shots, arthroscopic surgery or total joint replacements, which can all have significant drawbacks.

Many people are not aware that they can harness and concentrate their own bodys natural healing ability in the form of stem cells and platelets, said RBI Managing Director Jason Griffeth. There are safe and effective options that are treating these conditions through regenerative medicine.

Basically stem cells are the bodys natural repair cells, from which all other cells are derived. According to multiple research sources, stem cells can regenerate and heal injured tissue, as well as decrease inflammation. As we age, the amount of stem cells in our body declines as does our bodys ability to repair an injury.

RBIs Managing Director Jason Griffeth with Medical Director Dr. Brett Haake at their office across from Indian River Medical Center in Vero Beach(Photo: Fran Foster)

We found out that fat tissue is one of the richest sources of stem cell in the body and it works really well to unlock our bodies as a natural way of healing itself, Griffeth said, joking that Its not that bad to carry around a little extra fat.

The science behind it has been around since 1981 but has received more attention since money started pouring into the research. Professional athletes such as Mets pitcher Bartolo Colon and tennis star Rafael Nadal have reportedly used regenerative therapy to speed up injury recovery time.

In 2013, Harvard Medical School received a 10-year, multimillion grant from the National Football League Players Association for an initiative to prevent, treat and study football-related injuries.

The Mayo Clinic calls the therapy a "game-changing area of medicine," offering effective therapy for people whose conditions seem beyond repair.

Griffeth, a University of Florida masters graduate, studied biotechnology and cell science. He became fascinated with the human anatomy and its ability to help itself when he was working in Fort Lauderdale, in 2009, doing clinical studies with patients with damaged heart tissue.

RBI, located in Vero Beach, is committed to using stem cells for regenerative healing therapies once available only to professional athletes.(Photo: Fran Foster)

We would take a muscle biopsy from the thigh muscle, isolate the stem cells from that, then culture and expand them for about three weeks in our laboratory, he explained. Then we would use those cells to inject directly into the heart wall to help the damaged heart tissue. Of those studies, about a third of patients were significantly better, another third somewhat and the last third stayed the same but thats not necessarily a bad thing considering they didnt decline.

Currently, RBI is working on orthopedic conditions: arthritis, knee and other sport injuries.

Regenerative medicine is also not without its detractors. The FDA has approved just a handful of procedures (mainly for blood diseases such as leukemia) and insurance doesnt cover the treatment which can run into the thousands of dollars.

However, there are very few known side effects and very little recovery time. Plus, it's a treatment that addresses the underlying cause degenerating tissue as opposed to just treating symptoms.

Darragh said the only discomfort she had was when the cells were discharged into her knee there really wasnt a lot of room in there.

The guys (at RBI) laughed at me and said, You are only the second person that has complained about that. The other was a CrossFit athlete with little to no body fat especially around her joints.

Nevertheless, she walked out just fine, the same day.

RBI Medical Director Dr. Brett Haake believes there are a lot of misunderstandings about what regenerative medicine can do, as well as the science behind it.

The first way the public came to know about stem cells was through the embryonic stem cell research debate, where you are potentially destroying embryos, and the politics that come around that discussion, he said.

Haake explains, Its a simple process. We make a small incision, which doesnt even require stitches, go in and retract the fatty tissues. In about 45 minutes, we can isolate and concentrate on stem cells, combine them with your own highly concentrated platelets, which have a ton of growth factors, and inject them back to the area needed perhaps an elbow, a knee or an ankle.

Darragh says she researched treatments extensively and recommends others do the same.

Having this regenerative therapy is one of the best three things Ive done for myself. I had no idea it was available, although its very prominent in Europe and a lot of athletes use it, she says. The procedure makes perfect sense to me in that my body is healing itself. Im not introducing foreign objects, putting it through surgical trauma, taking pain medications. Its literally taking cells from one area to help heal another area. Your own body is healing your own body.

In regards to the procedure being ineligible for insurance coverage, she said that her insurance deductible was just as high, if not higher.

And the procedure only took a few hours. She loved the fact that the staff at RBI explained the entire process with enthusiasm and really believe in the work they are doing.

I have to say it lived up to exactly what they said it would do. I was in and out of the office the same day and was moving around right away, she said. Eight weeks later, its better than it has been for the past five years. Im planning on going back this December to have them work on my shoulder next.

Regenerative Biologics Institute (RBI) is located at 3755 Seventh Terrace, Suite 102 in Vero Beach. Visit their website at http://www.rbistemcell.com or call 772-492-6973.

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New Method Rescues Donor Organs to Save Lives – Laboratory Equipment

A multidisciplinary team led by Gordana Vunjak-Novakovic, Mikati Foundation Professor of Biomedical Engineering and Medical Sciences at Columbia Engineering, and Matt Bacchetta, associate professor of surgery at Columbia University Medical Center and NewYork-Presbyterian has--for the first time--maintained a fully functional lung outside the body for several days. In a study published today on Nature Biomedical Engineering's website, the researchers describe the cross-circulation platform that maintained the viability and function of the donor lung and the stability of the recipient over 36 to 56 hours. They used the advanced support system to fully recover the functionality of lungs injured by ischemia (restricted blood supply), and made them suitable for transplant.

The team was inspired by the critical need to expand the pool of donor lungs. Transplantation remains the only definitive treatment for patients with end-stage lung disease, but the number of donor lungs is much smaller than the number of patients in need, and many patients die while on the wait list. In addition, lungs quickly lose their function outside the body and during transport: four out of five lungs evaluated at transplant centers are rejected. If these lungs could be kept viable outside the body long enough, it would be possible to improve their function and use them for transplantation.

Over the past five years, Vunjak-Novakovic has been collaborating with Bacchetta and Hans Snoeck, professor of medicine, to investigate how to improve low-quality donor lungs and possibly bioengineer lungs for transplantation. Rather than attempting to build new lungs, they developed strategies to rescue damaged donor lungs. One approach was to use a stem cell therapy of the lung to replace defective cells with new therapeutic cells derived from the transplant recipient. While this technique was applicable to low-quality lungs that are rejected for transplantation, there was a problem: the support of the lung outside the body was too short for the therapeutic cells to start improving lung function.

As often happens, unmet clinical needs inspire new ideas and drive the development of new technologies. The Columbia team realized that "cross circulation"--an abandoned surgical procedure used in the 1960s to exchange blood flow between two patients--could enable long-term support of living organs outside the body by providing critical systemic and metabolic factors that are missing from all current technologies. The team embraced this idea and devised an entirely new approach to support lungs outside the body long enough to enable therapeutic interventions needed to recover their health and normal function.

"This is the most complex study we have ever done, and the one with the highest potential for clinical translation," Vunjak-Novakovic said. "The lung is a masterpiece of 'engineering by nature,' with its more than 40 cell types, and a gas exchange surface area of 100 square meters - half a tennis court. It is amazing that such an intricate organ can be maintained outside the body and even recovered following injury."

"Our team worked hard to innovate a suite of imaging and targeted delivery technologies and ultimately completed this challenging, paradigm-shifting study in less than a year. This was only possible because of our uniquely talented team of bioengineers and surgeons, and the highly collaborative environment at Columbia that fosters innovation," Vunjak-Novakovic said.

The team's breakthrough was realizing that cross-circulation could be re-configured to help recover damaged donor organs. The study's lead authors, Ph.D. candidate John O'Neill and postdoctoral research fellow Brandon Guenthart, looked at clinical studies from the 1960s that used cross-circulation of blood between a healthy individual and a patient suffering from a critical but potentially reversible illness. Working in Vunjak-Novakovic's Laboratory for Stem Cells and Tissue Engineering, they developed a radically new technology to support fully functional lung outside the body for several days.

"Our cross-circulation platform will likely allow us to extend the duration of support to a week or longer if needed, potentially enabling the recovery of severely damaged organs," observed O'Neill. "Beyond prolonging support time, we also demonstrated several therapeutic interventions that vastly improve and accelerate recovery."

As the team was developing their cross-circulation platform, they overcame many challenges to keep the lungs viable outside the body much longer than any platform had before. To prevent the outer surface of the lung from drying out and to provide normal body temperature, they designed a humidification system with ambient temperature control and a re-circulating warm water organ basin to provide normal body temperature to mimic the chest cavity.

Then they needed to tackle the perfusion circuit. To allow for adequate blood flow into and out of the lungs during cross-circulation, they developed new components and techniques and used a donor vessel as a "bio-bridge." They engineered a dynamic system capable of height and hydrostatic pressure adjustments and feedback-regulated pressure-controlled flow. They also developed image-guided techniques for the controlled delivery of drugs and cells in precisely targeted regions of the lung without the need for repeated lung biopsies.

"As our work progressed, we continued to innovate out of necessity and refine and streamline our cross-circulation setup and procedure," said Guenthart.

The researchers say their new platform could be readily extended to recover other organs that are in high demand for transplant or in need of repair, including livers and kidneys, and they have already begun studies in these directions.

"Cross-circulation has proven to be a valuable tool for investigation and has fostered interdisciplinary collaborations," Bacchetta said. "Our study is giving researchers new opportunities to investigate donor-recipient immunologic interactions, therapeutic cell delivery, stem cell differentiation, acute lung injury, and the development of new pulmonary theranostics."

Vunjak-Novakovic added, "Our goal was to develop a platform that harnesses the full potential of tissue engineering and regenerative medicine toward organ rescue. We hope that our unique technology will benefit the many patients in need and help them live fuller and happier lives."

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New Method Rescues Donor Organs to Save Lives - Laboratory Equipment

Ingeneron Gets $20M From Sanford Health For Stem Cell Treatment … – Xconomy

Xconomy Texas

HoustonIngeneron, a Houston-based developer of a stem cell-based technology, announced Monday that it has raised $20 million from strategic partner Sanford Health.

Ingeneron is developing a stem cell-based system meant to help patients recover from wounds and orthopedic ailments like a torn shoulder rotator cuff. In total, the company has raised $38 million from unspecified family offices and high net-worth individuals in both the United States and Germany.

Sanford Health, a large hospital chain based in Sioux Falls, SD, is conducting a small, 18-patient safety study of Ingenerons system, known as Transpose RT, being used to heal orthopedic ailments like torn shoulder rotator cuffs.Results are expected around the third quarter of this year, says Ron Stubbers, who was appointed the companys president following an executive shakeup last month. (Stubbers was previously InGenerons vice president of operations.)

Sanford Health has been involved with regenerative medicine for a long time, so this [investment] is continuing in that vein for them, Stubbers says.

Assuming all goes well, Ingeneron will have to run a much larger studylikely in 2018 and run into2019to test the products effectiveness and get it to market in the U.S., Stubbers says. Transpose RTis already sold in Europe for chronic wounds like venous ulcers. Ingeneron has also a second IDE in order to conduct a separate trial this spring to test the systems feasibility in healingchronic wounds.

Patients with torn or damaged rotator cuffs typically get a cortisone injection, but that just reduces inflammation and pain. It doesnt actually heal the tendon, as Ingenerons technology is meant to do.

Stubbers says Ingeneron has created a machine about the size of a table-top centrifuge that isolates and extracts stem cells taken from a patients fat tissue. Those cells are then injected into a patient, where theyre meant to help heal damaged tissue.

Ingeneron was founded in 2006 by Eckhard Alt, the companys chairman and a professor of medicine at the University of Texas MD Anderson Cancer Center, Tulane University in New Orleans, LA, and Technische Universitt in Munich. (Ingeneron also has an office in Munich.)

Although Ingenerons primary focus is orthopedic treatments and wound care, the company does have an animal health division. Its technology was used five years ago, for instance, at the Houston Zoo to treat a Malayan tiger with large bone chips in his right elbow and a female leopard with a bad limp from an elbow injury.According to a story in the Houson Chronicle, Pandu the tiger saw an improved quality of life from the procedure. Ultimately, both the elderly leopard and the 16-year-old tiger had to be euthanized in 2014 and 2015.

Angela Shah is the editor of Xconomy Texas. She can be reached at ashah@xconomy.com or (214) 793-5763.

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Ingeneron Gets $20M From Sanford Health For Stem Cell Treatment ... - Xconomy

Stem Cell Therapy: Modern Solution to Joint Pain Relief – PR Newswire (press release)

PLAINVIEW, N.Y., March 6, 2017 /PRNewswire/ -- Board certified surgeon Dr. Andrew J. Rochman promotes the specialized treatment of Stem Cell Therapy in his private practice in Plainview, NY. The recent wave of positive response from its ability to target a growing number of health conditions has brought increased attention and demand from pain sufferers everywhere- including the Long Island area.

As of the fall of 2016, Dr. Rochman officially opened the Cell Therapy Center of NY (CTCNY) where he focuses on the treatment of osteoarthritis & rheumatoid arthritis, eroded cartilage and joint issues like tennis elbow, jumpers knee and golf elbow. He dedicated his practice to the large population suffering from musculoskeletal damage arising from sports injuries or the wear and tear from aging. "We are always seeking a safer and more effective alternative to surgery to battle physiological symptoms with the hopes of giving patients a pain-free life."

Dr. Rochman underwent extensive training from U.S. Stem Cell, Inc. (Sunrise, FLA) - a center for the development of effective cell technologies recognized for treating a variety of diseases and injuries. U.S. Stem Cell's discoveries include multiple cell therapies in various stages of development that repair damaged tissue due to injury or disease. Chief Science Officer Kristin C. Comella, expert in regenerative medicine with a focus on adipose derived stem cells, pioneered stem cell therapies derived from various sources including cord blood, bone marrow and muscle. "By harnessing the body's own healing potential, we may be able to reverse damaged tissue to normal function.... stem cells have the ability to form many types of tissues like bone, cartilage, muscle and even help to reverse some effects that have been caused by damaged tissue," states Ms. Comella.

Dr. Rochman's treatment center has recently seen an influx of patients from Long Island's large athletic and fitness community. President of the Wildwood Warriors triathlon team, John Graziano is one of the many joint and back pain sufferers from sports injuries seeking this alternative pain treatment. "In the world of triathlon, I train- I race- and I live with pain and lots of it!"

"The potential here is limitless," states Dr. Rochman. "It's actually a simple yet unique form of therapy with the possibilities of doing miraculous things. We found out within the past several years that human beings have stem cells in every tissue of their body and they actually live around the blood vessels." Today's stem cell therapy has been shown to manage and target a wide span of healing possibilities from blood cell diseases to cardiac disorders to autoimmune diseases. "So what we can do now is to extract fat cells from the belly or bone marrow cells and isolate the cells from those damaged tissues... perhaps in the future we can utilize this process to target neurological diseases, heart diseases... and we don't even know where it ends," says Dr. Rochman.

Dr. Andrew J. Rochman is a native New Yorker and a board-certified surgeon. He is a graduate of Colgate University and received his formal medical training from Nordestana University. He is an active member of the American Medical Association, the Medical Society of the State of New York, Nassau County Medical Society and the American College of Phlebology. Dr. Rochman manages several practices in specialized studies such as advanced vein therapy and gallbladder surgery. His current certification is with U.S. Stem Cell, Inc. specializing in cardiovascular treatment through stem cell technology. The Cell Therapy Center of NY is located at 700 Old Country Road, Suite 205 Plainview, NY. For more information, visit: http://www.celltherapycenterny.com or call 516-280-1333.

Media contact: Lennard Gettz 148804@email4pr.com 631-553-8748

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/stem-cell-therapy-modern-solution-to-joint-pain-relief-300417654.html

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Scientists wage fight against aging bone marrow stem cell niche – Science Daily

Science Daily

Scientists wage fight against aging bone marrow stem cell niche Science Daily In a study published March 2, scientists from the University of Ulm in Germany and Cincinnati Children's Hospital Medical Center in the United States propose rejuvenating the bone marrow niche where HSCs are created. This could mean younger acting ... and more »

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Scientists wage fight against aging bone marrow stem cell niche - Science Daily

StemBioSys Lands Experimental UT Tech That Finds Young Stem Cells – Xconomy

Xconomy Texas

San Antonio StemBioSys, the life sciences company with a system for growing stem cells, has licensed an experimental technology from University of Texas Health San Antonio that may help identify healthy young adult stem cells among large pools of other cells.

Theres plenty of research examining how to possibly use adult stem cells as treatments for medical conditions, ranging from cardiac disease to metabolic disorders, but current uses are rather limited to therapies like bone-marrow transplants for blood disorders, especially in children. Treatments that use patients own stem cells may be safer than using stem cells from someone else because they might reduce the potential for an immune response, according to StemBioSys CEO Bob Hutchens. Thats still theoretical, he says.

Finding large quantities of usable adult stem cells is difficult, though. StemBioSys believes its new technology can potentially identify a few thousand high-quality, young stem cells from a sample of tens of thousands of cells taken from a patient, Hutchens sayspotentially being a key word.

The research is quite earlythe technology has only been studied in animal models and in vitro, and StemBioSys is in the process of applying for federal grants to take the research into animal trials. If StemBioSys new intellectual property can successfully isolate the stem cells, Hutchens says they could grow more of them with StemBioSys core product.

StemBioSys sells a so-called extracellular matrix product made of proteins that provide a hospitable environment for stem cells, helping them divide and produce more stem cells.

Whats intriguing to us is that its a really interesting application of our technology, Hutchens says. You take this combination of identifying this very small population of young healthy cells in elderly people, and use our technology to expand it.

If the company can indeed find the young stem cells of a single patient and replicate them, it would give researchers and physician an accessible pool of the cells that theyd want for potential stem cell transplants and other treatments, Hutchens says.

Terms of the deal werent disclosed. StemBioSys, which was founded based on other University of Texas System research, acquired a portfolio of issued and pending patents. Famed MIT researcher and Xconomist Robert Langer is on the companys board of directors.

Again, theres plenty to prove out with this early stage research, so it will take time before any potential commercialization comes to fruition. Travis Block, the researcher who helpeddevelopthe technology while earning his PhD. last year at the University of Texas Health Science Center at San Antonio, will help shepherd the project along and other regenerative medicine work as StemBioSyss senior scientist.

David Holley is Xconomy's national correspondent based in Austin, TX. You can reach him at dholley@xconomy.com

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StemBioSys Lands Experimental UT Tech That Finds Young Stem Cells - Xconomy

Bones made to order at University of Rochester, thanks to 3-D printers – Rochester Democrat and Chronicle

Scientists at URMC are researching how to use 3-D printing to create bone replacement. Jamie Germano

University of Rochester Medical Center Scientists Hani Awad, left, and Edward Schwarz explain how they are leading the way in using 3-D printing and stem cells to create bone replacements for patients.(Photo: Jamie Germano/@jgermano1/Staff Photographer)Buy Photo

Imagine getting a made-to-order bone implanted in your body that's composed of your own cells.

Scientists at the University of Rochester Medical Center have been developing a procedure to use3-D printing and stem cells fromthe patient to createbones made of regenerated tissue.

Thismulti-step procedure still has a ways to go before it is tested on humans and can become part of the services provided by URMC's Center for Musculoskeletal Research.Butit's the latest example of how 3-D printing, which isincreasingly finding its place in manufacturing, is leaving its mark in medicine.

It is changing the way we do a lot of things, saidHani Awad, who is associate director of the center and professor of biomedical engineering with aspecialty in tissue engineering.

Biomedical research, as it is being done in this initiative, is an important component of the medical center's identity.

"Part of our mission is that we want to do research that is impactful," said Stephen Dewhurst, vice dean for research at the medical center.

A 3-D replica of a spinal deformity in a child that gives surgeons a hands-on look at a problem before surgery. The replica is made with a 3-D printer at the University of Rochester Medical Center.(Photo: Jamie Germano/@jgermano1/Staff P)

UR is already using 3-D printing to create replicas of human organs to practice on before conducting difficult surgical procedures.

The Center for Musculoskeletal Research is trying to gobeyond this use of3-D printing.

Simulated surgery makes headway at UR Medical Center

Edward Schwarz, director of the center, andAwadare heading up an initiative that not only makes replicas of bones for doctors to better understand and show patients the problems they face, butis alsousing 3-D printing to create the framework for regenerating bone tissue.

Currently, a person with a badly damaged limb that cannot be healed by surgical means faces amputation, followed bythe fitting of an artificial limb.

Bones from cadavers arealso sometimes used as replacement limbs, but there is a high failure rate withcadaver limbs over time. That's because cadaver bonesare not living tissue and thus cannot repair themselves when the limb suffers minor fractures, as they often do.

Bone regeneration offers the prospect of a new alternative.

Thesurgically implanted replica serves as a framework to regenerate bone tissue.

"A big part of the problem is figuring out how to grow a big piece of bone,"said Awad.

With the technology developed, a3-D replicais created by taking a CT scan of the patient's bone. What's recorded by the scan is thenconverted by a computer into a digital modelthat programsthe 3-D printer.

If a leg is too badly damaged tomake a replica, a CTscan can be taken of the patient's other leg. And with the use of computer technology, any needed modification can be made. ACT scan of a left leg could be made to look like it isa right leg in the 3-D printout.

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During a recent demonstration, thestainless steel platform of the 3-D printer,which moves up and down, wasreplenished with a supply of powdered calcium phosphate a materialsimilar to bone.

The printer's inkjets wereprogrammed by computer to spray a binding solution of phosphoric acid in a patternthat formed a thighbone.

Over the course of an hour or so, the 3-D printer creating one thin layer on top of another builtthe artificial human boneabout 1 inch thick and 6inches long.

But that's not where this bone replacement procedure ends.

The next step and one not yet tried on humans is regeneration of tissue using stem cells wrapped around the replacementbone.

Schwarz and Awad have beentesting bone regeneration on mice, without any indicationof rejection and with signs of bone regeneration.

And they are beginning to test regeneration on mini-pigs.

The 3-D replica bones arecoated with sheets ofstem cells, whichregenerate bone tissue. Eventually, the 3-D part of the replacement bones made of calcium phosphate isexpected to be absorbed by new bone tissue.

Awad estimates that this tissue regeneration technology couldbe triedon humans in three to five years.

Research at the University of Rochester uses 3-D printing to create bone replacements. Jamie Germano

UR is among a handful of universitiesdoing research that combines 3-D technologyand tissue regeneration.

"The exact horizon is unclear, but we are certainlyrunning full-speed ahead," said Dr. Paul Rubery, chairman of the Department of Orthopaedics at the UR Medical Center.

3-D printing, Rubery noted, makes possible the reproduction of intricate shapes, including those in the human body.

"What is the science one might say what is the magic that will make a person's body take on a new part and make it a living part?" said Rubery about the possibility of bone regeneration using stem cells and 3-D technology.

The Medical Center is well positioned to figure this out.

"We havea long tradition of understanding the molecular processes that lead to healing and repair of the skeleton," said Rubery.

The Musculoskeletal Center, which is inRubery'sdepartment, last fiscal year received the second highest amount of funding for such centers fromthe National Institutes of Health roughly $10 million. About65 researchers and technicians are on staff.

The other half of the equation is the Medical Centers Upstate Stem Cell cGMP Facility, where stemcells are grown in accordance with strict Food and Drug Administration regulations.

Located in the Medical Center's Ernest J. Del Monte Neuromedicine Institute, the cGMP was established in 2012, with the help of a $3.5 million grant from the Empire State Stem Cell Board.

In bone regeneration, the stem cells are usually taken by syringe at the hip, where such cells are plentiful, and then grown in petri dishes atthecGMP Facility.

Schwarz, who is a professor of orthopaedics, said what's mostneeded before the procedure can beused on humans is work on how the stem cells are transferred from the cGMP facility to the 3-D replicas.

"Youbasically have to demonstrate that you can harvest the cells, grow the cells andre-implant the cells in a safe and effective manner," said Schwarz.

Currently, the alternative to an artificial leg is one from a cadaver, but that is done only in limited situations.

"If the bone is not alive, it eventually becomes structurally weakened," said Dewhurst.

Bone grafts are also done, buthere, too,the graftcomesfrom cadavers in thevast majority of cases, said Awad.

Regenerating bone tissue would provide a different dynamic creating live bone tissue that replenishes itself.

Rejection is not expected to be an issue because the stem cellswould come from the patient.

Unlike other cells, stem cells have the capability to divide indefinitely, so they can grow new bone tissue.

Awad and Schwarz are among the authors of studies in scientific journals that show the effectiveness of stem cells in healing damaged bones in mice.

In a laboratory at the Musculoskeletal Center is a tabletop full of replicas of human bones and bone structures made by the 3-D printer in the room.

The replica of the spine is that of a childwho suffered from a severe curvature.

Having such a model enabled a doctor to figure out what kind of steps could be taken to address the problem.

The 3-D skull on the table is a replica of a human skulland provides a way researchers can study howinjuries can be treated.

A hole was made in the cheekbone to resemble a bullet wound. Another replicawas missing part of a jaw.

Inboth cases, the goalis to have stem cells regenerate bone tissue.

The body can naturally healitself in the normal course of injuries, but can't do so when the bone is damaged beyond repair.

Implanting a 3-D bone coated withhuman stem cells would offer an alternative to existing choices.

"It is really going to be part of UR Medicine and its health care system," said Schwarz.

JGOODMAN@Gannett.com

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Bones made to order at University of Rochester, thanks to 3-D printers - Rochester Democrat and Chronicle

Cellect Biotechnology (APOP) Announces Positive Results of Clinical Trial of ApoGraft – StreetInsider.com

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Cellect Biotechnology Ltd. (Nasdaq: APOP) announced today positive final results from its clinical trial of ApoGraft in healthy donors. The studys primary objective was to validate the Company's propriety method of stem cell selection by going through the process of production and characterization with ApoGraft, and was conducted on samples obtained in collaboration with two leading medical centers in Israel, The Schneider Children's Medical Center and the Rambam Medical Center.

Cellects technology enables the use of stem cells for regenerative therapies by eliminating mature cells while leaving the stem cells unharmed using a natural process occurring in the human body, apoptosis (programed cell death), which orders cells to commit suicide. Cellects validated scientific platform, and the focus of its 7 families of patents, is that the apoptosis command destroys primarily mature cells, while stem cells remain alive and flourishing. This process allows for natural enrichment of stem cells, thus enabling stem cell-based therapies or transplantation to possess an abundance of quality stem cells with little to no risk of rejection or other complications, such as Graft versus Host Disease (GvHD).

The study included 104 healthy donors of blood stem cells. The samples (collected under approval of Helsinki committees) represented 5% of a graft used for transplantation into patients. The grafts were processed allowing stem cell production for transplantation with Cellects ApoGraft. The use of the ApoGraft resulted in a significant increase in the death of mature immune cells, primarily T Lymphocytes, without compromising the quantity and quality of stem cells. The process takes only a few hours as compared to days of complex and expansive lab work with traditional methods, is anticipated to be extremely cost effective in comparison to current approaches, and has the potential to significantly reduce the risk of GvHD.

Dr. Yaron Pereg, Cellects Chief Development Officer, commented: These results from processing human stem cells for bone marrow transplantation using ApoGraft clearly demonstrated that Cellects proprietary platform could improve the outcome of stem cell transplantations in patients suffering from hematological malignancies.

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Cellect Biotechnology (APOP) Announces Positive Results of Clinical Trial of ApoGraft - StreetInsider.com

Cellect Announces Positive Clinical Trial Results – P&T Community

Cellect Announces Positive Clinical Trial Results P&T Community The Company's technology is expected to provide pharma companies, medical research centers and hospitals with the tools to rapidly isolate stem cells for in quantity and quality that will allow stems cell related treatments and procedures. Cellect's ... and more »

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Cellect Announces Positive Clinical Trial Results - P&T Community