A Stem Cells Based Product on the Way?
Boston, MA, June 11, 2010 ? Stem cell therapies are making strides in Europe with news of the intent of an unnamed biomedical company to market a stem cell-based product, according to the European Medicines Agency (EMA).
The EMA, based in London, England, made headlines last month when they released a press release stating that ?for the first time the agency has an opportunity to evaluate the application for marketing authorization for a stem cell-based product.?
The EMA assembled European and international experts from academia, regulatory authorities from Europe, Japan and the USA and the pharmaceutical industry in response to the application and to discuss regulatory challenges, the release said.
?Stem cells hold the promise of an unlimited source of cells for therapeutic applications to treat patients who have no or only unsatisfactory treatment options. However, these therapies bear certain risks, such as tumorigenicity and immunorejection, hence need to be carefully regulated with the input from multi-disciplinary expertise,? said Christian Schneider, chairman of the EMA?s Committee for Advanced Therapies.
According to the EMA, around 40 clinical trials are currently on-going in Europe that validate the use of stem cells in regeneration of lost or damaged tissue (heart, skin, bone, spinal cord, liver, pancreas and cornea) and in hematological and solid-organ malignancies. The majority of these trials are using mesenchymal cells.
Biocell Center, an international company based in Europe and the United States is a unique private tissue bank of stem cells from amniotic fluid that will be considered ?qualified material? for clinical trials and use.
?Amniotic fluid is one of the best and richest sources of mesenchymal stem cells that are viewed as the next frontier in stem cell therapy,? said Biocell Center CEO, Dr. Kate Torchilin. ?Biocell Center can provide pregnant women across North America who are having a genetic amniocentesis for prenatal diagnosis the opportunity to bank stem cells from their amniotic fluid, for future potential treatment of various diseases and for regenerative medicine.?
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Other press releases from Biocell Center Corporation
Advances in Medical Technology Allow Women to Get Pregnant Later in Life and Preserve Stem Cells During Amniocentesis - June 8th, 2010
New Data Highlights Additional Benefits of Amniotic Mesenchymal Stem Cells - June 7th, 2010
Biocell Center - the Nation's First Amniotic Stem Cell Bank - Is Favored by European Celebrity Women - June 3rd, 2010
Biocell Center - the Nation's First Amniotic Fluid Stem Cell Bank - Reaches Out to Online Moms - May 31st, 2010
Biocell Center ? the Nation?s First Amniotic Fluid Stem Cell Bank - Furthers its Commitment to the OB/GYN Community - May 26th, 2010
Biocell Center Appears on Doctor Radio - May 24th, 2010
Biocell Center Partners with New England's Largest Community-Based Hospital Network to Offer a Unique Service in Amniotic Fluid Stem Cell Preservation - May 21st, 2010
Contact Information
Laurie Fullerton
Title: Public Relations Director
Biocell Center Corporation
200 Boston Avenue
Boston, Medford, MA 02155
Phone: 781- 391-2040
Alt. Phone: 1-866-246-2720
Fax: 1-781-395-0602
Email: laurie.fullerton@biocellcenter.com
Visit Website http://biocellcenter.com
Boston, MA, June 11, 2010 ? Stem cell therapies are making strides in Europe with news of the intent of an unnamed biomedical company to market a stem cell-based product, according to the European Medicines Agency (EMA).
The EMA, based in London, England, made headlines last month when they released a press release stating that ?for the first time the agency has an opportunity to evaluate the application for marketing authorization for a stem cell-based product.?
The EMA assembled European and international experts from academia, regulatory authorities from Europe, Japan and the USA and the pharmaceutical industry in response to the application and to discuss regulatory challenges, the release said.
?Stem cells hold the promise of an unlimited source of cells for therapeutic applications to treat patients who have no or only unsatisfactory treatment options. However, these therapies bear certain risks, such as tumorigenicity and immunorejection, hence need to be carefully regulated with the input from multi-disciplinary expertise,? said Christian Schneider, chairman of the EMA?s Committee for Advanced Therapies.
According to the EMA, around 40 clinical trials are currently on-going in Europe that validate the use of stem cells in regeneration of lost or damaged tissue (heart, skin, bone, spinal cord, liver, pancreas and cornea) and in hematological and solid-organ malignancies. The majority of these trials are using mesenchymal cells.
Biocell Center, an international company based in Europe and the United States is a unique private tissue bank of stem cells from amniotic fluid that will be considered ?qualified material? for clinical trials and use.
?Amniotic fluid is one of the best and richest sources of mesenchymal stem cells that are viewed as the next frontier in stem cell therapy,? said Biocell Center CEO, Dr. Kate Torchilin. ?Biocell Center can provide pregnant women across North America who are having a genetic amniocentesis for prenatal diagnosis the opportunity to bank stem cells from their amniotic fluid, for future potential treatment of various diseases and for regenerative medicine.?
Download as PDF
Other press releases from Biocell Center Corporation
Advances in Medical Technology Allow Women to Get Pregnant Later in Life and Preserve Stem Cells During Amniocentesis - June 8th, 2010
New Data Highlights Additional Benefits of Amniotic Mesenchymal Stem Cells - June 7th, 2010
Biocell Center - the Nation's First Amniotic Stem Cell Bank - Is Favored by European Celebrity Women - June 3rd, 2010
Biocell Center - the Nation's First Amniotic Fluid Stem Cell Bank - Reaches Out to Online Moms - May 31st, 2010
Biocell Center ? the Nation?s First Amniotic Fluid Stem Cell Bank - Furthers its Commitment to the OB/GYN Community - May 26th, 2010
Biocell Center Appears on Doctor Radio - May 24th, 2010
Biocell Center Partners with New England's Largest Community-Based Hospital Network to Offer a Unique Service in Amniotic Fluid Stem Cell Preservation - May 21st, 2010
Contact Information
Laurie Fullerton
Title: Public Relations Director
Biocell Center Corporation
200 Boston Avenue
Boston, Medford, MA 02155
Phone: 781- 391-2040
Alt. Phone: 1-866-246-2720
Fax: 1-781-395-0602
Email: laurie.fullerton@biocellcenter.com
Visit Website http://biocellcenter.com