As we get older, our body’s capacity to repair injuries diminishes.
STEM CELL THERAPY It is a process by which new cells are introduced to the body to treat your specific condition.
Unlike many traditional treatments, some of high cost, with side effects, which are directed to the symptoms rather than to the causes. Stem cell therapy has had very promising results with potentially curable answers.
For the type of condition or disease to be treated, the medical team requires a broad knowledge of the patient’s condition, treatment alternatives and evidence that the steps to follow can offer a successful outcome.
The fundamentals of the BioXcellerator quality management system are based on the following regulations and standards for cell therapy, safety, and infrastructure conditions:
CAT Standards for the Obtention, Processing, Storage and Distribution of Blood Umbilical cord.
INVIMA (the institution that fulfills the role of the FDA in Colombia) Standards: Good Practices for Tissue Banks and Bone Marrow.
FACT-JACIE International standards for the collection, processing, and administration of hematopoietic cell therapy products.
ISO 14644: 2016 Standard Air quality in controlled environments.
ISO 9001: 2015 Standard Quality Management Systems
Colombian resolution 2378 of 2008 Adoption of Good Clinical Practices for Research with Medicines in Humans (specifically for clinical research projects)
ASS-RSA-GU045 Clinical Investigation Medicine and Supplies Guide INVIMA.
ISSCR International Society for Stem Cell Research.
GMP Spanish Agency of Medicines and Health Products.
Enabling Standards under Colombian Resolution 2003 of 2014
STEM CELL THERAPY OFFERS NO GUARANTEES AND IS NOT PROMOTED AS A CURE. THIS IS SIMILAR TO MANY OTHER CONVENTIONAL MEDICAL TREATMENTS. A REVIEW OF THE PATIENT’S MEDICAL HISTORY IS REQUIRED TO DETERMINE ELIGIBILITY AND APPROVAL FOR STEM CELL THERAPY. ANY PERSONAL INFORMATION PROVIDED IS FOR INTERNAL AND MEDICAL USE WITH OUR MEDICAL PROVIDERS ONLY. BIOX IS HEADQUARTERS IN PHOENIX, ARIZONA AND IS A RESOURCE COMPANY AND PROVIDER NETWORK FOR BIOXCELLERATOR IN MEDELLIN, COLOMBIA. BIOXCELLERATOR ARIZONA IS NOT A STEM CELL TREATMENT FACILITY OR SURGICAL CENTER. TREATMENTS ARE NOT CONDUCTED IN OUR OFFICES OR IN THE U.S. SINCE THESE ADVANCED THERAPIES ARE NOT YET APPROVED BY THE FDA. ALL CELL THERAPIES ARE CONDUCTED IN COLOMBIA, AS IT IS REGULATED BY THE MINISTRY OF HEALTH, INVIMA AND OTHER LOCAL AUTHORITIES. ALL TREATMENTS ARE PERFORMED WITHIN THE LEGAL LIMITS AND REGULATORY FRAMEWORK FOR THE COUNTRY IN WHICH THE SPECIFIC MEDICAL PROVIDER PRACTICES.
