Stem Cell Clinic

BioLife Solutions CryoStor Cell Preservation Media Embedded In Cardio3 BioSciences' Phase III Clinical Trials Of C …

By Uncategorized

BioLife Solutions, Inc., a leading developer, manufacturer and marketer of proprietary clinical grade hypothermic storage and cryopreservation freeze media and precision thermal shipping products for cells and tissues (BioLife or the Company), recently announced that Cardio3 BioSciences, a leader in engineered cell therapy with clinical programs initially targeting indications in cardiovascular disease and oncology, has embedded the Companys clinical grade CryoStor cryopreservation freeze media in its ongoing Congestive Heart Failure Cardiopoietic Regenerative Therapy (CHART-1) phase III clinical trial in Europe and Israel and the pending CHART-2 phase III clinical trial to be conducted in the United States.

CHART-1 (Congestive Heart Failure Cardiopoietic Regenerative Therapy) is a patient prospective, controlled multi-centre, randomized, double-blinded Phase III clinical trial comparing treatment with C-Cure to a sham treatment. The trial has recruited 240 patients with chronic advanced symptomatic heart failure. The primary endpoint of the trial is a composite endpoint including mortality, morbidity, quality of life, Six Minute Walk Test and left ventricular structure and function at nine months post-procedure.

Dr. Christian Homsy, CEO of Cardio3 BioSciences, commented on the selection of CryoStor by stating, We evaluated several possible freeze media formulations for our clinical cell therapy product development and manufacturing. CryoStor and BioLife best met our preservation efficacy, product and supplier quality, and customer support requirements.

As of January 2015, BioLife management estimates that the Companys CryoStor freeze media and HypoThermosol cell and tissue storage/shipping media have been incorporated into at least 175 customer clinical trials of novel cellular immunotherapies and other cell-based approaches for treating and possibly curing the leading causes of death and disorders throughout the world. Within the cellular immunotherapy segment of the regenerative medicine market, BioLife's products are embedded in the manufacturing, storage, and delivery processes of at least 75 clinical trials of chimeric antigen receptor T cells (CAR-T), T cell receptor (TCR), dendritic cell (DC), tumor infiltrating lymphocytes (TIL), and other T cell-based cellular therapeutics targeting solid tumors, hematologic malignancies, and other diseases and disorders. A large majority of the currently active private and publicly traded cellular immunotherapy companies are BioLife customers.

Mike Rice, BioLife Solutions CEO, remarked; We are honored to be able to supply our clinical grade CryoStor cell freeze media for Cardio3 Biosciences phase III clinical trials. Congestive heart failure is a leading cause of death and C-Cure is a novel and potentially life-saving, cellbased therapy that offers hope to millions of patients throughout the world. We are very well positioned to participate in the growth of the regenerative medicine market, with our products being used in at least 75 phase II and over 20 phase III clinical trials of new cell and tissue based products and therapies.

About Cardio3 Biosciences Cardio3 BioSciences is a leader in engineered cell therapy with clinical programs initially targeting indications in cardiovascular disease and oncology. Founded in 2007 and based in the Walloon region of Belgium, Cardio3 BioSciences leverages research collaborations in the USA with the Mayo Clinic (MN, USA) and Dartmouth College (NH, USA). The Companys lead product candidate in cardiology is C-Cure, an autologous stem cell therapy for the treatment of ischemic heart failure. The Companys lead product candidate in oncology is CAR- NKG2D, an autologous CAR T-cell product candidate using NKG2D, a natural killer cell receptor designed to target ligands present on multiple tumor types, including ovarian, bladder, breast, lung and liver cancers, as well as leukemia, lymphoma and myeloma. Cardio3 BioSciences is also developing medical devices for enhancing the delivery of diagnostic and therapeutic agents into the heart (CCath ) and potentially for the treatment of mitral valve defects.

Cardio3 BioSciences shares are listed on Euronext Brussels and Euronext Paris under the ticker symbol CARD. For more information, visit c3bs.com

About C-Cure Cardio3 BioSciences C-Cure therapy involves taking stem cells from a patients own bone marrow and through a proprietary process called Cardiopoiesis, re-programming those cells to become heart cells. The cells, known as cardiopoietic cells, are then injected back into the patients heart through a minimally invasive procedure, with the aim of repairing damaged tissue and improving heart function and patient clinical outcomes. C-Cure is the outcome of multiple years of research conducted at Mayo Clinic (Rochester, Minnesota, USA), Cardio3 BioSciences (Mont-Saint-Guibert, Belgium) and Cardiovascular Centre in Aalst (Aalst, Belgium). C-Cure is currently in Phase III clinical trials (CHART-1, approved by the EMA and CHART-2, for which enrollment will begin once final approval is received from FDA). The results of the Phase II trial, completed in January 2012, were published in the Journal of the American College of Cardiology (JACC) in April 2013. The publication reported a significant improvement in treated patients.

About BioLife Solutions BioLife Solutions develops, manufactures and markets hypothermic storage and cryopreservation solutions and precision thermal shipping products for cells, tissues, and organs. BioLife also performs contract aseptic media formulation, fill, and finish services. The Companys proprietary HypoThermosol and CryoStor biopreservation media products are highly valued in the biobanking, drug discovery, and regenerative medicine markets. BioLifes proprietary products are serum-free and protein-free, fully defined, and are formulated to reduce preservation-induced cell damage and death. This enabling technology provides commercial companies and clinical researchers significant improvement in shelf life and post-preservation viability and function of cells, tissues, and organs. For more information, visit http://www.biolifesolutions.com

Originally posted here:
BioLife Solutions CryoStor Cell Preservation Media Embedded In Cardio3 BioSciences' Phase III Clinical Trials Of C ...

Telehealth Stem Cell Clinic Now Offering Wound Healing Guarantee

By Uncategorized

La Jolla, California (PRWEB) April 13, 2015

The top stem cell therapy clinic in Southern California, Telehealth, is now offering a wound healing guarantee with its innovative stem cell therapy program.The program works exceptionally well for those dealing with nonhealing wounds as a result of diabetes or other issues. Simply call (888) 828-4575 for more information and scheduling at any of the stem cell clinics in La Jolla, Irvine, Orange or Upland.

Nonhealing wounds lead to considerable disability and the potential for infection and amputation. Telehealth has developed a stem cell therapy that routinely works for healing these problematic wounds, especially for diabetic ulcers.

The stem cell therapy wound healing guarantee includes closing an ulcer wound within 90 days as long as it is less than 2 cm x 4 cm in size. Thankfully, Telehealth is also able to close larger ones as well. The Board Certified physicians have extensive experience with stem cell therapy for all types of musculoskeletal conditions.

There are several types of stem cell procedures available at the four locations in La Jolla, Irvine, Orange and Upland. Board certified physicians perform the procedures and oversee the care.

In addition to treating nonhealing wounds, Telehealth also treats degenerative arthritis, tendonitis, ligament injuries, degenerative disc disease, peripheral artery disease and more.

The stem cell therapy for nonhealing wounds is often partially covered by insurance. For more information and to schedule an appointment with the top stem cell clinics in Southern California, call (888) 828-4575.

Read more:
Telehealth Stem Cell Clinic Now Offering Wound Healing Guarantee

CryoStor Cell Preservation Selected For Phase III Clinical Trials of C-Cure Cell Therapy for Congestive Heart Failure

By Uncategorized

BioLife Solutions, Inc. (NASDAQ: BLFS), a leading developer, manufacturer and marketer of proprietary clinical grade hypothermic storage and cryopreservation freeze media and precision thermal shipping products for cells and tissues (BioLife or the Company), today announced that Cardio3 BioSciences, a leader in engineered cell therapy with clinical programs initially targeting indications in cardiovascular disease and oncology, has embedded the Companys clinical grade CryoStor cryopreservation freeze media in its ongoing Congestive Heart Failure Cardiopoietic Regenerative Therapy (CHART-1) phase III clinical trial in Europe and Israel and the pending CHART-2 phase III clinical trial to be conducted in the United States.

CHART-1 (Congestive Heart Failure Cardiopoietic Regenerative Therapy) is a patient prospective, controlled multi-centre, randomized, double-blinded Phase III clinical trial comparing treatment with C-Cure to a sham treatment. The trial has recruited 240 patients with chronic advanced symptomatic heart failure. The primary endpoint of the trial is a composite endpoint including mortality, morbidity, quality of life, Six Minute Walk Test and left ventricular structure and function at nine months post-procedure.

Dr. Christian Homsy, CEO of Cardio3 BioSciences, commented on the selection of CryoStor by stating, We evaluated several possible freeze media formulations for our clinical cell therapy product development and manufacturing. CryoStor and BioLife best met our preservation efficacy, product and supplier quality, and customer support requirements.

As of January 2015, BioLife management estimates that the Companys CryoStor freeze media and HypoThermosol cell and tissue storage/shipping media have been incorporated into at least 175 customer clinical trials of novel cellular immunotherapies and other cell-based approaches for treating and possibly curing the leading causes of death and disorders throughout the world. Within the cellular immunotherapy segment of the regenerative medicine market, BioLife's products are embedded in the manufacturing, storage, and delivery processes of at least 75 clinical trials of chimeric antigen receptor T cells (CAR-T), T cell receptor (TCR), dendritic cell (DC), tumor infiltrating lymphocytes (TIL), and other T cell-based cellular therapeutics targeting solid tumors, hematologic malignancies, and other diseases and disorders. A large majority of the currently active private and publicly traded cellular immunotherapy companies are BioLife customers.

Mike Rice, BioLife Solutions CEO, remarked; We are honored to be able to supply our clinical grade CryoStor cell freeze media for Cardio3 Biosciences phase III clinical trials. Congestive heart failure is a leading cause of death and C-Cure is a novel and potentially life-saving, cell-based therapy that offers hope to millions of patients throughout the world. We are very well positioned to participate in the growth of the regenerative medicine market, with our products being used in at least 75 phase II and over 20 phase III clinical trials of new cell and tissue based products and therapies.

About Cardio3 Biosciences Cardio3 BioSciences is a leader in engineered cell therapy with clinical programs initially targeting indications in cardiovascular disease and oncology. Founded in 2007 and based in the Walloon region of Belgium, Cardio3 BioSciences leverages research collaborations in the USA with the Mayo Clinic (MN, USA) and Dartmouth College (NH, USA). The Companys lead product candidate in cardiology is C-Cure, an autologous stem cell therapy for the treatment of ischemic heart failure. The Companys lead product candidate in oncology is CAR- NKG2D, an autologous CAR T-cell product candidate using NKG2D, a natural killer cell receptor designed to target ligands present on multiple tumor types, including ovarian, bladder, breast, lung and liver cancers, as well as leukemia, lymphoma and myeloma. Cardio3 BioSciences is also developing medical devices for enhancing the delivery of diagnostic and therapeutic agents into the heart (CCath) and potentially for the treatment of mitral valve defects. Cardio3 BioSciences shares are listed on Euronext Brussels and Euronext Paris under the ticker symbol CARD. To learn more about Cardio3 BioSciences, please visit c3bs.com

About C-Cure Cardio3 BioSciences C-Cure therapy involves taking stem cells from a patients own bone marrow and through a proprietary process called Cardiopoiesis, re-programming those cells to become heart cells. The cells, known as cardiopoietic cells, are then injected back into the patients heart through a minimally invasive procedure, with the aim of repairing damaged tissue and improving heart function and patient clinical outcomes. C-Cure is the outcome of multiple years of research conducted at Mayo Clinic (Rochester, Minnesota, USA), Cardio3 BioSciences (Mont-Saint-Guibert, Belgium) and Cardiovascular Centre in Aalst (Aalst, Belgium). C-Cure is currently in Phase III clinical trials (CHART-1, approved by the EMA and CHART-2, for which enrollment will begin once final approval is received from FDA). The results of the Phase II trial, completed in January 2012, were published in the Journal of the American College of Cardiology (JACC) in April 2013. The publication reported a significant improvement in treated patients.

About BioLife Solutions BioLife Solutions develops, manufactures and markets hypothermic storage and cryopreservation solutions and precision thermal shipping products for cells, tissues, and organs. BioLife also performs contract aseptic media formulation, fill, and finish services. The Companys proprietary HypoThermosol and CryoStor biopreservation media products are highly valued in the biobanking, drug discovery, and regenerative medicine markets. BioLifes proprietary products are serum-free and protein-free, fully defined, and are formulated to reduce preservation-induced cell damage and death. This enabling technology provides commercial companies and clinical researchers significant improvement in shelf life and post-preservation viability and function of cells, tissues, and organs. For more information please visit http://www.biolifesolutions.com, and follow BioLife on Twitter.

Originally posted here:
CryoStor Cell Preservation Selected For Phase III Clinical Trials of C-Cure Cell Therapy for Congestive Heart Failure

NYC Health & Longevity Center Now Offering Stem Cell Therapy to Avoid Joint Replacement

By Uncategorized

NYC, NY (PRWEB) April 13, 2015

NYC Health & Longevity Center is now offering outpatient stem cell therapy to help patients avoid joint replacement in all extremities. The treatments are performed by a Board Certified physician, with most patients being able to avoid or delay the need for surgery. Simply call (844) GET-STEM for more information and scheduling with stem cell therapy NYC trusts.

Millions of joint replacements are performed in the US annually for degenerative arthritis of the knee, hip, shoulder, elbow, wrist and ankle. While these are mostly effective, they are not risk free procedures and should be avoided as long as possible. In addition, the implants placed are not meant to last forever.

With stem cell therapy now being commercially available, individuals now have access to the most cutting-edge procedures with the potentially to actually regenerate damaged tissue. This includes cartilage, ligament and tendon.

The stem cell procedures are performed by a Board Certified Anti-Aging doctor with considerable experience in both the stem cell procedures along with prolotherapy too.

The stem cell material comes from amniotic fluid that is obtained from consenting donors after a scheduled C-section, which is then processed at an FDA regulated lab. No fetal tissue or embryonic stem cells are used, eliminating any ethical concerns. Amniotic fluid causes no rejection, and has a very high amount of stem cells, growth factors and anti-inflammatory effects. The overall result is typically tremendous pain reduction and functional improvements that are long lasting.

Stem cell therapy for arthritis is performed on an outpatient basis, with absolutely minimal risk. The procedure takes less than a half hour, with patients able to return to desired activities quickly.

Along with degenerative arthritis, the stem cell procedures also help rheumatoid arthritis along with tendonitis of the rotator cuff, Achilles, elbow and knee. Athletes benefit from typically being able to avoid surgery and get back their sport much faster than with conventional treatments.

For more information on stem cell therapy at NYC Health & Longevity Center for extremity arthritis of the hips, knees, shoulders, elbow, wrist or ankle, call (844) GET-STEM.

Read more here:
NYC Health & Longevity Center Now Offering Stem Cell Therapy to Avoid Joint Replacement

Mesoblast takes partnership with Celgene, shares rise 27pc

By Stem Cell Treatment

Mesoblast chief executive Silviu Itescu says new strategic partner Celgene has a "strong franchise and sales and marketing. Photo: Josh Robenstone

Mesoblast chief executive Silviu Itescu says a $58.5 million investment from pharmaceutical giant Celgene gives the company a strong potential route to market as the stem cell therapy developernears its first sales.

The American giant Celgene, which had revenue of $US7.7 billion ($10 billion) from treatments for cancers and inflammatory diseases like psoriasis, picked up 15.3 million shares at $3.82 a share. Investors welcomed the deal, pushing the volatile stock up 24 per cent to $3.99 on Monday.

The surge boosted the value of Mr Itescu's 22 per cent stake in the company by $53 million to $272 million.

Mesoblast shares have lost about 16 per cent in the past year, compared with a 10 per cent rise in the benchmark S&P/ASX 200 index.

The stock last traded at the placement price a month ago, but has traded as high as $5.75 in the past year. Mr Itescu said Mesoblast and Celgene began talks about six months ago. He described the deal as "a fair transaction".

"The right time is when you come to an arrangement with a strategic partner," he said. "Where the share price is at any given time is much less relevant to the value of the technology and the partnership."

As part of the deal, which gives Celgene a stake of about 4.5 per cent, the company will have first right of refusal over licensing deals for the commercialisation of Mesoblast's adult stem cell products in the treatment of certain diseases.

That is, if Mesoblast is approached by another company to licence itsdrug candidates for the prevention and treatment of acute graft versus host disease (GVHD), certain oncologic diseases, inflammatory bowel diseases, and organ transplant rejection, Celgene will have six months in which it can mull whether it would like to trump the deal.

Mr Itescu said Celgene has a "strong franchise and sales and marketing capability" in cancer and inflammatory diseases. He said Mesoblast's candidate for the treatment of graft versus host disease, a common complication of bone marrow transplants used to treat cancer, "fits perfectly well into their cancer and oncology franchise."

Read this article:
Mesoblast takes partnership with Celgene, shares rise 27pc

Study: Gene therapy superior to half-matched transplant for 'bubble boy disease'

By Stem Cell Treatment

Research first to compare alternative approaches to fully matched transplant for rare immune disorder

(WASHINGTON - April 13, 2015) - New research published online today in Blood, the Journal of the American Society of Hematology (ASH), reports that children with "bubble boy disease" who undergo gene therapy have fewer infections and hospitalizations than those receiving stem cells from a partially matched donor. The research is the first to compare outcomes among children with the rare immune disorder - also known as X-linked severe combined immunodeficiency (SCID-X1) - receiving the two therapeutic approaches.

Children with SCID-X1 are born with a genetic defect that prevents them from developing a normal immune system. Because they are prone to life-threatening infections, infants with SCID-X1 must be kept in a sterile, protective bubble and require extensive treatment for survival beyond infancy. Infants with SCID are most likely to survive if they receive a stem cell transplant from a fully matched donor - typically a sibling - a procedure that replaces an infant's diseased stem cells with healthy donor cells. Following a successful fully matched transplant, infants with SCID-X1 are able to produce their own immune cells for the first time.

In the absence of a fully matched stem cell donor, infants with SCID-X1 may receive a transplant from a partial, or "half-matched," donor - typically their mother or father. They may also undergo gene therapy, a much different approach. Gene therapy for SCID-X1 involves extracting an infant's own bone marrow, using a virus to replace faulty genetic material with a correct copy, and then giving "corrected" bone marrow back to the patient. Half-matched stem cell transplant and gene therapy represent secondary treatment approaches for infants with SCID-X1. Until recently, researchers had not yet compared outcomes among children treated with each respective approach.

"Over the last decade, gene therapy has emerged as a viable alternative to a partial matched stem cell transplant for infants with SCID-X1," said lead study author Fabien Touzot, MD, PhD, of Necker Children's Hospital in Paris. "To ensure that we are providing the best alternative therapy possible, we wanted to compare outcomes among infants treated with gene therapy and infants receiving partial matched transplants."

Dr. Touzot and colleagues studied the medical records of 27 children who received either partial-matched transplant (13) or gene therapy (14) for SCID-X1 at Necker Children's Hospital between 1999 and 2013. The children receiving half-matched transplants and the children receiving gene therapy had been followed for a median of six and 12 years, respectively.

The researchers compared immune, or T-cell, development among patients and also compared key clinical outcomes such as infections and hospitalization. Investigators observed that the 14 children in the gene therapy group developed healthy immune cells faster than the 13 children in the half-matched transplant group. In fact, in the first six months after therapy, T cell counts had reached normal values for age in more than three-fourths (78%) of the gene therapy patients, compared to roughly one-fourth (26%) of the transplant group. The more rapid growth of the immune system in gene therapy patients was also associated with faster resolution of some opportunistic infections (11 months in gene therapy group vs. 25.5 months in half-matched transplant group). These patients also had fewer infection-related hospitalizations (3 in gene therapy group vs. 15 in half-matched transplant group).

"Our analysis suggests that gene therapy can put these incredibly sick children on the road to defending themselves against infection faster than a half-matched transplant," Dr. Touzot said. "These results suggest that for patients without a fully matched stem cell donor, gene therapy is the next-best approach."

###

Blood, the most cited peer-reviewed publication in the field of hematology, is available weekly in print and online. Blood is the official journal of the American Society of Hematology (ASH), the world's largest professional society concerned with the causes and treatment of blood disorders.

Read the rest here:
Study: Gene therapy superior to half-matched transplant for 'bubble boy disease'

→←