Bello XOL is an acellular, lyophilized product containing billions of exosomes derived from umbilical cord tissue. Labeled for topical use in North America, the product is amazing at facilitating collagen, elastin and fibrin formation for turning on the “time machine” for your patients.
FAQ
GMP stands for Good Manufacturing Practice, which is a set of regulations, rules, and guidelines published by all healthcare authorities. Examples of these healthcare authorities include:
GMP regulations provide us with a system that should ensure consistent, controlled products and services. Good implementation of the regulation requirements and guidelines helps us provide the best and safest services and products. These GMP guidelines include all aspects of the product’s life cycle and manufacturing process, from product development and raw materials selection to the final production process, testing, storage, and shipment.
The “c” stands for “current” as a reminder that systems, processes and technologies must be kept up to date to comply with the latest regulations. "
It is important to understand that the FDA does not “approve” or certify health care facilities, laboratories, or manufacturers as GMP. The FDA inspects product manufacturers to verify that they comply with good manufacturing practices but does not issue GMP certificates.
Birth tissue refers to the “products of conception” that are typically discarded as medical waste after a birth. This may include the placenta, amniotic fluid, umbilical cord tissue and umbilical cord blood.
Of note, Bello Bio USA obtains birth tissue from an accredited tissue recovery agency in the USA. This agency screens consenting donors rigorously to make sure they are acceptable with the lowest risk factors possible.
Bello Bio Pakistan maintains its own birth tissue recovery program. As Bello Bio is located within Pak-American Hospital (PAH), mothers undergoing scheduled c-sections at the hospital may consent to donate their birth tissue.
Bello Bio performs rigorous donor screening both on the mother as well as the tissue itself. The tissue testing is consistent with the regulations put forth by the FDA.
The United States FDA has put forth the term Minimal Manipulation referring to tissue products where the processing of the HCT/P does not alter the original relevant characteristics of the tissue relating to the tissue's utility for reconstruction, repair, or replacement.
HCT/P refers to human cells, tissues, and cellular and tissue-based products. Here is how the FDA regulations read (word for word).
The FDA defines minimal manipulation as:
The products manufactured at Bello Bio USA or Pakistan are only available for purchase by licensed healthcare professionals. Bello Bio places a current license on file for each customer.
Bello Bio employs several molecular biologists. These individuals are key to the successful production of the clinical and research biologics in both the USA and Pakistan. In order to become a molecular biologist, individuals must study for several years at an institution of higher learning. Once they complete all of the rigorous course load to master the technology necessary for working in the field, they must put forth a strong dissertation and successfully defend it to a faculty committee.
The process of obtaining a PhD as a Molecular Biologist generally takes 4 to 6 years. Drs. Khan and Minter-Dykhouse both obtained their PhD from highly respectable institutions, are well published and have devoted their lives to producing and researching first rate cellular therapy products.
Molecular biologists play a vital role in advancing our understanding of genetics, cell biology, and biochemistry. Their research is used in a variety of fields, including medicine, agriculture, biotechnology, and environmental science. Molecular biologists may work in academic settings, government agencies, or private industry, where they conduct research, develop new technologies, and analyze data to solve complex biological problems.
“Bello” is an Italian word meaning beautiful. “Bio” is short for biologics which means the study of life. Together, Bello Bio means the Beautiful Study of Life!
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This website is intended to inform and educate medical professionals. It is NOT intended for patients. It also does not seek to make claims about the effectiveness of regenerative medicine and its respective therapies in medical treatment.
Regenerative therapies have great potential in helping treat a range of conditions.
This site serves to inform medical professionals about regenerative medicine, Bello Bio allograft products, and key in vitro, animal model, and clinical research studies that have been carried out to date across medical specialties and health conditions. However, regenerative medicine is an early and evolving field.
While the Bello Bio products are produced in an FDA compliant laboratory in the USA, they have not been approved by the FDA for treatment effectiveness. The FDA states:
Like other medical products that are intended to treat, cure or prevent disease, generally require FDA approval before they can be marketed. FDA has not approved any stem cell-based products for use, other than cord blood-derived hematopoietic progenitor cells (blood-forming stem cells) for certain indications.
Patients interested in regenerative therapy in the U.S. are advised to consult a physician about the state of approval for any given product and/or inquire about opportunities to participate in a clinical trial. It is important to be aware that regulations and clinical study requirements vary from country to country.
By clicking yes you confirm that you are a medical professional, understand that the information contained in this website is intended for medical professionals and not for the general public, and have read and understood the disclaimer above.
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