Category Archives: Regenerative Medicine

ALAMEDA, Calif.--(BUSINESS WIRE)--

BioTime, Inc. (NYSE MKT: BTX) and its subsidiary OrthoCyte Corporation today announced the appointment of Francois Binette, PhD, as OrthoCytes Vice President of Research and Business Development. Dr. Binettes primary focus will be to develop and partner near- and long-term product opportunities in regenerative medicine with an emphasis on orthopedic diseases and injuries. OrthoCyte is a wholly owned subsidiary of BioTime, Inc. that develops cellular therapeutics for orthopedic repair, diseases, and injuries.

I am impressed by the robust nature of the novel and diverse progenitors of skeletal tissues that BioTime has isolated using its ACTCellerateTM technology, said Dr. Binette. The ability to generate scalable and precisely identified types of cartilage, bone, and tendon, combined with the HyStem technology for tissue engineering, gives us a remarkable platform for manufacturing an array of novel products to address some of the largest and fastest growing needs in the orthopedic space. I look forward to building on the science and technology developed at OrthoCyte to aggressively develop the companys product pipeline and pursue partnering opportunities.

Francois brings tremendous expertise in regenerative medicine, cell therapy, biologics, biomaterials, and combination medical devices. He also has significant business experience in partnering and collaboration with both start-up and large life science companies, said Michael D. West, PhD, BioTimes Chief Executive Officer. We welcome Francois to the OrthoCyte team and look forward to working together with him in developing commercial product opportunities for the orthopedic repair market.

Dr. Binette most recently was the founder of Rediens Inc., a Bay Area start-up company focused on chronic back pain therapies. Prior to establishing Rediens, he wasDirector of BiologicsR&D for the Spinal & Biologics business unit of Medtronic, Inc., and he also served in a variety of positions with Johnson & Johnson, where he focused on regenerative medicine therapies for various orthopedic indications, including cartilage injuries and back pain. Dr. Binette began his corporate career at Genzyme Tissue Repair, where he helped pioneer Carticel, the first FDA Biologic License Application-approved cell therapy product. Dr. Binette received his PhD in Biochemistry at Laval University in Qubec and was a postdoctoral research fellow at the LaJolla Cancer Research Foundation of the Sanford-Burnham Medical Research Institute and at MGH/Harvard Medical School. He is currently a fellow with the International Cartilage Repair Society.

About OrthoCyte Corporation

OrthoCyte Corporation (OrthoCyte), http://www.orthocyte.com, a subsidiary of BioTime, Inc., is a biotechnology company developing cell-based therapies for orthopedic disease. The company's lead product is OTX-CP07, monoclonal human embryonic progenitor cell lines for the repair of osteoarthritis. In addition, OrthoCyte has proprietary human embryonic stem cell-derived progenitors to skeletal muscle, tendon, and bone, all of which are in the preclinical phase of development.

About BioTime, Inc.

BioTime, headquartered in Alameda, California, is a biotechnology company focused on regenerative medicine and blood plasma volume expanders. Its broad platform of stem cell technologies is enhanced through subsidiaries focused on specific fields of application. BioTime develops and markets research products in the fields of stem cells and regenerative medicine, including a wide array of proprietary ACTCellerate cell lines, HyStem hydrogels, culture media, and differentiation kits. BioTime is developing Renevia (formerly known as HyStem-Rx), a biocompatible, implantable hyaluronan and collagen-based matrix for cell delivery in human clinical applications. BioTime's therapeutic product development strategy is pursued through subsidiaries that focus on specific organ systems and related diseases for which there is a high unmet medical need. BioTime's majority-owned subsidiary Cell Cure Neurosciences Ltd. is developing therapeutic products derived from stem cells for the treatment of retinal and neural degenerative diseases. BioTime's subsidiary OrthoCyte Corporation is developing therapeutic applications of stem cells to treat orthopedic diseases and injuries. Another subsidiary, OncoCyte Corporation, focuses on the diagnostic and therapeutic applications of stem cell technology in cancer, including the diagnostic product PanC-Dx currently being developed for the detection of cancer in blood samples. ReCyte Therapeutics, Inc. is developing applications of BioTime's proprietary induced pluripotent stem cell technology to reverse the developmental aging of human cells to treat cardiovascular and blood cell diseases. BioTime's subsidiary LifeMap Sciences, Inc. markets GeneCards, the leading human gene database, and is developing an integrated database suite to complement GeneCards that will also include the LifeMap database of embryonic development, stem cell research and regenerative medicine, and MalaCards, the human disease database. LifeMap will also market BioTime research products. BioTime's lead product, Hextend, is a blood plasma volume expander manufactured and distributed in the U.S. by Hospira, Inc. and in South Korea by CJ CheilJedang Corporation under exclusive licensing agreements. Additional information about BioTime can be found on the web at http://www.biotimeinc.com.

Forward-Looking Statements

Link:
BioTime Subsidiary OrthoCyte Corporation Announces the Appointment of Francois Binette as Vice President

By Thomas Vihtelic, Director, Experimental Therapeutics, MPI Research

Regenerative medicine is attracting significant attention as a medical technology capable of treating what were previously determined to be untreatable diseases. Scientists worldwide are engaged in stem cell research that may enable the repair of damaged heart muscle after a heart attack, restore movement after spinal cord injury, regenerate pancreatic tissue to produce insulin for people with diabetes, and achieve long-sought medical remedies. Animal studies with cell-based therapeutics have demonstrated success, although technological and scientific hurdles remain. Preclinical assessments of cell-based therapies to demonstrate proof of concept and evaluate the risk-benefit ratio for human use present unique challenges requiring expertise and specialized technical capabilities.

This paper presents an overview of stem cell types, their therapeutic risk factors, and preclinical research objectives. The applications of cell-based therapies for selected diseases based on animal models and the qualities to look for when choosing a contract research organization (CRO) for evaluating stem cell-based products are also discussed.

Downloads

Cellular Therapeutics And Regenerative Medicine: Preclinical Assessments For Proof Of Concept And Safety

See the original post:
Cellular Therapeutics And Regenerative Medicine: Preclinical Assessments For Proof Of Concept And Safety

CIRM: “To support and advance stem cell research and regenerative medicine under the highest ethical and medical standards for the discovery and development of cures, therapies, diagnostics and research technologies to relieve human suffering from chronic disease and injury.”

CIRM: For-profit entities have been and currently are eligible for CIRM funding covering stages of research which range from basic biology programs (in which industry has shown little interest) through Phase II clinical trials. Of these programs, 13% have been awarded to companies thus far. Having built 12 state of the art stem cell facilities and having seeded  the field with training and other types of grants of similar purpose, CIRM is now focusing on funding translational and clinical programs.  

This is where companies' primary interests are and we expect greater company participation in our translation and clinical Request for Application. The translation and clinical awards programs provide for much larger awards as compared to the basic research and the overall amount of later stage funding is significantly larger than the earlier basic research awards. The number of awards made in the translational and clinical development funding rounds is much less than in the basic science area. 

CIRM’s Strategic Partnership Funding Program is a cornerstone of our efforts to fund industry.   We expect to make awards through this program approximately every six months to assist companies whose financing demands is frequently at shorter intervals than academic institutions. These awards will be made following a robust peer review process ensuring that awards are made to projects that are based on sound scientific data and have a reasonable chance of success.

CIRM: Four clinical trials that were fostered by CIRM funds are already in clinical trials for cancer and blood disorders. We expect one or more CIRM-funded projects to join that list in the next year. This includes projects that are in clinical trial already for which we have funded and are funding the follow on studies.

CIRM: Yes, we have recently held the first round of applications for our Strategic Partnership Awards that are designed specifically to attract applications from industry and include significant leveraged funding from multinational biopharmaceutical companies and/or venture capital. The first of these awards will be announced at an upcoming meeting of our governing board, the Independent Citizens Oversight Committee. Industry also accesses CIRM funding through the Disease Team awards, which include teams comprised of both academic researchers and industry as partners, consultants and advisors. 

CIRM: No. We have awarded more basic research grants in numbers, but those grants are much smaller in dollars than those in our translational portfolio. That translational portfolio includes 75 projects that have been awarded nearly $600 million, well over half of the research dollars committed.

When CIRM funding was initiated in late 2006, there was a need to build intellectual and facility capacity because doubts about support from federal sources had limited the entry of scientists into the field and there was a need for “safe harbor facilities. “ Research into stem cells was also at an early stage and so it made sense for us to focus on the discovery phase of basic biology and pre-clinical work to enable more effective utilization of the potential that was evident.

Increasingly however we are moving towards clinical science, to enable a proper assessment of the value of cell therapies and related approaches for advancement of human medicine.

Our focus has always included all stem and progenitor cells. Pluripotential stem cells are immortal and develop into all cells of the body, so the potential is large and the available funding outside CIRM has been modest. We have concentrated on human rather than animal model cells because this is where the need has been greatest. Our goal is to fund transformational research with the highest potential benefit to patients, regardless of the stem cell type they utilize.

As for infrastructure, we spent $271 million in major facilities grants to help create new, state-of-the-art safe harbor research facilities in California which are essential for  delivering  the goals of CIRM. That investment was used to leverage almost $900 million in additional funds from private donors and institutions to help pay for those facilities. Each facility  attracted new researchers to the state,  employed local construction workers  and created expanded research facilities that will now be able to offer long-term employment for the high tech innovators in stem cell research, transformative new medicines  for intractable disease and deliver economic benefit for Californians.

CIRM: Yes, our focus in our new Strategic Plan does just that, emphasizing the increased focus on translation and clinical trials. As described above, we are investing strongly in this sector. But we firmly believe that advancement in medicine is dependent on the science that underpins the medical strategies. We will also  continue to support high quality basic science that can transform medical opportunities.  

CIRM: We are required by our statute to fund in those areas that are under-invested. Otherwise we are agnostic to cell type. We expect a mixture of embryonic (induced pluripotent stem cells as well when they are ready for clinical studies), fetal, adult, cancer stem and progenitor cells, as well as small molecules, biologics and other approaches, evolving from stem cell assays and research. We are most concerned with the ability to produce results for patients.

Yes, we have appointed a Vice President with business development responsibilities and are further strengthening this capacity with key staff. We are actively working with industry to develop sustainable partnerships in research, we hold webinars and face to face meetings with the FDA to better equip industry with the tools that can aid in their investigational new drug (IND) submissions . We also assist industry to better understand what they need to do to successfully apply for CIRM funding.

We have also made changes to our intellectual property regulations and loan regulations to make it even more attractive for companies  to partner with us in research.

Our focus has been in moving promising research through the "Valley of Death" phase, from the lab through Phase 1 and 2 clinical trials. We are working with major industry and financial institutions to inform them of our developing portfolio with the belief that they will be interested in taking many of these products to the market place. We are probably unable to afford to do these late stage clinical trials alone and feel it is likely that commercial interests will provide the follow on funding. 

CIRM: We are always interested in proposals that will enhance our mission. While this hypothetical has not been put to us we would have to assess the proposal on its merits and our available finances. 

CIRM:  In our RFA’s we have provided guidance as to what entities qualify for CIRM funding.  Future requirments  are presently under review by our General Counsel. Certainly, companies will need to show genuine steps at the time of application  towards relocation of a significant component of their research activities to California in addition to establishing a California operation with California employees. CIRM funding would be largely limited to in-state  activities.

http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com

Source:
http://feedproxy.google.com/~r/CellTherapyBlog/~3/wzhx7dkP3vk/cirm-addresses-some-tough-questions-is.html

CT model portfolio compared to 3 major indices YTD

• Cell Therapy Portfolio:  +24.44%
• Dow Jones:  +4.5%
• S+P 500:  +6.78%
• Nasdaq:  +10.26%

http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com

Source:
http://feedproxy.google.com/~r/CellTherapyBlog/~3/ediPNE1NBDw/cell-therapy-portfolio-outperforms.html

CT model portfolio compared to 3 major indices YTD

• Cell Therapy Portfolio:  +24.44%
• Dow Jones:  +4.5%
• S+P 500:  +6.78%
• Nasdaq:  +10.26%

http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com

Source:
http://feedproxy.google.com/~r/CellTherapyBlog/~3/ediPNE1NBDw/cell-therapy-portfolio-outperforms.html

Newswise WINSTON-SALEM, N.C. While it is well known that starfish, zebrafish and salamanders can re-grow damaged limbs, scientists understand very little about the regenerative capabilities of mammals. Now, researchers at Wake Forest Baptist Medical Centers Institute for Regenerative Medicine report on the regenerative process that enables rats to re-grow their bladders within eight weeks.

In PLOS ONE, a peer-reviewed, online publication, the scientists characterize this unique model of bladder regeneration with the goal of applying what they learn to human patients.

A better understanding of the regenerative process at the molecular and cellular level is a key to more rapid progress in applying regenerative medicine to help patients, said George Christ, Ph.D., senior researcher and professor of regenerative medicine at Wake Forest Baptist.

In a previous study by Christs team, research in rats showed that when about 75 percent of the animals bladders were removed, they were able to regenerate a complete functional bladder within eight weeks. The current study focused on how the regeneration occurs.

There is very little data on the mechanisms involved in organ regeneration in mammals, said Christ. To our knowledge, bladder regeneration holds a unique position there is no other mammalian organ capable of this type of regeneration.

The ability of the liver to grow in size when lobes are removed is sometimes referred to as regeneration, but this is a misnomer, said co-author Bryon Petersen, Ph.D., who was a professor of regenerative medicine at Wake Forest Baptist during the period the research occurred. Instead, through a proliferation of cells, the remaining tissue grows to compensate for the lost size. In contrast, the hallmark of true regeneration is following natures pattern to exactly duplicate size, form and function, Petersen said.

If we can understand the bladders regenerative process, the hope is that we can prompt the regeneration of other organs and tissues where structure is important from the intestine and spinal cord to the heart, said Petersen.

The current study showed that the animals bodies responded to injury by increasing the rate at which certain cells divided and grew. The most notable proliferative response occurred initially in the urothelium, the layer of tissue that lines the bladder.

As the proliferative activity in the bladder lining waned, it continued elsewhere: in the fibrous band (lamina propria) that separates the bladder lining from the bladder muscles and in the bladder muscle itself.

The researchers have several theories about how the process works, said Christ. One possibility is that cells in the bladder lining transition and become a type of stem cell that can proliferate throughout the bladder. Other theories are that cells in the bladder lining signal other cells to replicate and that injury prompts stem cells to arrive through the blood stream to repair the bladder damage.

Read more from the original source:
Scientists Identify Mammal Model of Bladder Regeneration

MARLBOROUGH, Mass.--(BUSINESS WIRE)--

Advanced Cell Technology, Inc. (ACT; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that the Data and Safety Monitoring Board (DSMB), an independent group of medical experts closely monitoring the Companys three ongoing clinical trials, has authorized the Company to move forward with enrollment and treatment of second and third additional patients with Stargardts macular dystrophy (SMD) in the second patient cohort of its U.S. trial for the condition. Additionally, the DSMB has authorized the Company to treat all three patients in the second cohort of its European trial for SMD.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) recently approved a protocol modification to the DSMB review, streamlining the process, allowing the company to treat the first patient in a new cohort if the DSMB has allowed this in the US study, and once clearance has been received in the US trial to treat the next two patients in the US cohort. This would also allow for treatment of the UK patients without an additional review by the DSMB. Moreover, according to the protocol for both trials, each patient in the second cohort will be injected with 100,000 human embryonic stem cell (hESC)-derived retinal pigment epithelial (RPE) cells, up from 50,000 in the first cohort.

This authorization to treat the next five patients in the second, higher-dosage cohort in both our clinical trials for SMD represents a significant step forward for our clinical programs, commented Gary Rabin, chairman and CEO of ACT. We are also encouraged with the MHRAs approval of the DSMBs streamlined review process. Clearly this has the potential to help accelerate the pace of our European trial.

ACT is conducting three clinical trials in the U.S. and Europe using hESC-derived RPE cells to treat forms of macular degeneration, SMD and dry age-related macular degeneration (dry AMD). Each trial will enroll a total of 12 patients, with cohorts of three patients each in an ascending dosage format, from 50,000 hESC-derived RPE cells in the first patient cohort to 200,000 in the last and final cohort. These trials are prospective, open-label studies, designed to determine the safety and tolerability of hESC-derived RPE cells following sub-retinal transplantation into patients with dry-AMD or SMD at 12 months, the studys primary endpoint.

We are eagerly anticipating treating these final two patients in the second cohort of our U.S. trial for SMD, and all three patients in the second cohort of our E.U. trial, commented Robert Lanza, M.D., ACTs chief scientific officer. We are encouraged by the preliminary data in the first patient in this second, higher-dosage cohort and look forward to gathering more data.

Further information about patient eligibility for ACTs SMD studies in the U.S. and E.U. as well as its dry AMD study are available atwww.clinicaltrials.gov,with the following Identifiers: NCT01345006 (U.S. SMD), NCT01469832 (E.U. SMD), and NCT01344993 (dry AMD).

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc., is a biotechnology company applying cellular technology in the field of regenerative medicine. For more information, visit http://www.advancedcell.com.

Forward-Looking Statements

Go here to read the rest:
ACT Announces Approval to Treat Additional Stargardt’s Disease Patients with Higher RPE Dosage in Both U.S. and ...

Kyodo / Reuters

Kyoto University Professor Shinya Yamanaka (left) and John Gurdon of the Gurdon Institute in Cambridge, England, at a symposium on induced pluripotent stem cells in Tokyo in April 2008

In a testament to the revolutionary potential of the field of regenerative medicine, in which scientists are able to create and replace any cells that are at fault in disease, the Nobel Prize committee on Monday awarded the 2012 Nobel in Physiology or Medicine to two researchers whose discoveries have made such cellular alchemy possible.

The prize went to John B. Gurdon of the University of Cambridge in England, who was the first to clone an animal, a frog, in 1962, and to Shinya Yamanaka of Kyoto University in Japan who in 2006 discovered the four genes necessary to reprogram an adult cell back to an embryonic state.

Sir John Gurdon, who is now a professor at an institute that bears his name, earned the ridicule of many colleagues back in the 1960s when he set out on a series of experiments to show that the development of cells could be reversed. At the time, biologists knew that all cells in an embryo had the potential to become any cell in the body, but they believed that once a developmental path was set for each cell toward becoming part of the brain, or a nerve or muscle it could not be returned to its embryonic state. The thinking was that as a cell developed, it would either shed or silence the genes it no longer used, so that it would be impossible for a cell from an adult animal, for example, to return to its embryonic state and make other cells.

(MORE: Stem Cell Miracle? New Therapies May Cure Chronic Conditions Like Alzheimers)

Working with frogs, Gurdon proved his critics wrong, showing that some reprogramming could occur. Gurdon took the DNA from a mature frogs gut cell and inserted it into an egg cell. The resulting egg, when fertilized, developed into a normal tadpole, a strong indication that the genes of the gut cell were amenable to reprogramming; they had the ability to function as more than just an intestinal cell, and could give rise to any of the cells needed to create an entirely new frog.

Just as Gurdon was facing his critics in England, a young boy was born in Osaka, Japan, who would eventually take Gurdons finding to unthinkable extremes. Initially, Shinya Yamanaka would follow his fathers wishes and become an orthopedic surgeon, but he found himself ill-suited to the surgeons life. Intrigued more by the behind-the-scenes biological processes that make the body work, he found himself drawn to basic research, and began his career by trying to find a way to lower cholesterol production. That work also wasnt successful, but it drew him to the challenge of understanding what makes cells divide, proliferate and develop in specific ways.

In 2006, while at Kyoto University, Yamanaka stunned scientists by announcing he had successfully achieved what Gurdon had with the frog cells, but without using eggs at all. Yamanaka mixed four genes in with skin cells from adult mice and turned those cells back to an embryo-like state, essentially erasing their development and turning back their clock. The four genes reactivated other genes that are prolific in the early embryo, and turned off those that directed the cells to behave like skin.

(MORE: Ovary Stem Cells Can Produce New Human Eggs)

Here is the original post:
Stem Cell Scientists Awarded Nobel Prize in Physiology and Medicine

Eqalix Inc., an emerging regenerative medicine company, announces its Scientific Advisory Board (SAB). This SAB gives Eqalix a depth and breadth of experience necessary to take it to the next level.

Reston, VA (PRWEB) October 09, 2012

"We are very pleased to bring together these key thought leaders to establish the Eqalix Scientific Advisory Board," stated Joseph P. Connell, Eqalix CEO and Chairman of the Board. "I have worked with Drs. Gold and Goldman for years and have always admired their abilities. Dr Lelkes technologies will make a profound impact upon aesthetic dermatology, wound healing and regenerating blood vessels, nerve endings and damaged organs with the guidance of this distinguished panel. It is not clich in any manner when I say that we are thrilled to work with this team. We look to their guidance, industry knowledge and network to help deliver these therapies into clinic and prospective patients as soon as possible, as I am confident our technologies will make a difference, said Connell.

The members of the Eqalix Scientific Advisory Board are:

Peter I. Lelkes, PhD: Chief Scientific Advisor; Dr. Lelkes is the Laura H. Carnell Professor and Founding Chair of the Department of Bioengineering in the College of Engineering at Temple University and the Inaugural Director of the Institute for Regenerative Medicine and Engineering (TIME) at Temple Universitys School of Medicine. While at Drexel, Prof. Lelkes directed an interdisciplinary program in tissue engineering and regenerative medicine, focusing on nanotechnology-based biomaterials and soft tissue engineering, employing developmental biological principles to enhance the tissue-specific differentiation of embryonic and adult stem cells. Dr. Lelkes has organized several Keystone conferences and published more than 160 peer-reviewed papers and 45 book chapters and made more than 400 presentations nationally and internationally.

Dr. Lelkes basic and translational research has been support by federal (NIH, NSF, NASA, DOE) and state funding agencies, (NTI and Dept. of Commerce, Tobacco Settlement Funds) and private Foundations, including the Coulter Foundation. Most recently, Dr. Lelkes has been named Director of the Surgical Engineering Enterprise, one of the major initiatives of the strategic plan of Drexel Universitys College of Medicine. In addition, Dr. Lelkes has been the team leader for tissue engineering at the Nanotechnology Institute of Southeastern Pennsylvania (NTI) and is the Co-Director of PATRIC, the Pennsylvania Advanced Textile Research and Innovation Center, focusing on BioNanoTextiles and Stem Cell Biology.

Dr Lelkes stated, "I am delighted and excited to partner with Eqalix to translate our inventions from the bench to the bedside in a timely fashion.

Mitchel P. Goldman, MD, Scientific Advisor, Founder and Medical Director of Goldman Butterwick Fitzpatrick, Groff & Fabi, Cosmetic Laser Dermatology. A graduate of Boston University, Summa Cum Laude, and the Stanford University Medical School, Dr. Goldman is a Volunteer Clinical Professor in Medicine/Dermatology at the University of California, San Diego. Dr Goldman is Board Certified by both the American Board of Dermatology and the American Board of Cosmetic Surgery.

He is a fellow of the American Academy of Dermatology, American Society for Dermatologic Surgery, American Society for Laser Medicine and Surgery, American Academy of Cosmetic Surgery and the American Society of Liposuction Surgery. He is former President of the American College of Phlebology and President-Elect of the American Society for Dermatologic Surgery. He presently serves on the Board of Trustees for the American Academy of Cosmetic Surgery. He also has authored and/or co-authored 21 Textbooks on Dermatology, Sclerotherapy, Ambulatory Phlebectomy, Cutaneous Laser Surgery, Cellulite and Dermatologic Surgery as well as over 300 peer-reviewed publications and textbook chapters.

Dr Goldman added: I am very interested and excited to work with the Eqalix team to make these technologies a success. I believe that my background lends well to truly shaping the successful commercialization of these products for my patients to improve outcomes.

View original post here:
Regenerative Medicine Biotech Company, Eqalix, Names Scientific Advisory Board