IRB approval for Adipose Derived Stem Cell processing protocols.
EATONTOWN, N.J., July 10, 2013 -- American CryoStem Corporation (OTCQB: CRYO) announced that its protocols for the processing of Stromal Vascular Fraction (SVF) and culturing of mesenchymal stem cells from autologous adipose tissue have been approved by the Institutional Review Board (IRB) of the International Cell Surgical Society (1CSS).
The two protocols are "Autologous Adipose Tissue-Derived Stromal Vascular Fraction (SVF) Containing Adult Stem Cells with Isolation of SVF" and "Culturing of Adipose Derived Stem Cells (ADSCs) For Use in Institutional Review Board Studies".
These protocols provide appropriate testing methods necessary to move the clinical investigative process towards uniform treatments, and the collection of cGMP processing and outcome data required by prevailing FDA regulations and guidance for approval of regenerative cellular therapies, including potency (cell count), contamination testing and cell viability.
The company will make available its processing services utilizing the IRB approved protocols to physicians and clinical researchers for inclusion in their studies.
By adopting these protocols and the laboratory services of American CryoStem, researchers can focus their resources on application development rather than creating, validating and managing a clinical laboratory for processing tissue and cellular samples.
These protocols do not involve actual human clinical trials, but affords the IRB the opportunity to endorse standardized and validated processing methodologies for the isolation of SVF and for tissue culture expansion of ADSCs obtained from SVF.
The ICSS IRB thoroughly evaluated every step of American CryoStem's processing protocols, which serve to isolate the SVF or ADSCs from a patient's adipose tissue.
The objective of the IRB is to assess these protocols to ensure the highest patient safety possible and to minimize the risks for those participating in innovative research and investigational studies.
"The purpose of obtaining IRB approval of our processing protocols is to make it easier for physicians to study the safety of SVF and ADSCs using a standardized processing methodology that characterizes, as well as tests the sample for sterility and viability," said CEO John S. Arnone.
The ICSS IRB comprises medical and scientific experts as well as informed community members. The IRB is registered with the Office for Human Research Protections (OHRP), a part of the U.S. Department of Health and Human Services. The IRB, managed by International Cell Surgical Society, is a California based physician organization dedicated to education, advancing research and advocating for cell-based regenerative medicine.
"In view of the extraordinarily rapid and extensive use of Adipose Derived Stem Cells clinically, it is imperative that standards for processing and identification of these cells be established along with cGMP data collection to assure that the cells used in the patients' treatments are in fact SVF or ADSCs," said David Audley of International Cell Surgical Society.
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|Title Annotation:||Stem Cell Processing Protocols|
|Publication:||Stem Cell Business News|
|Date:||Jul 15, 2013|
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