Research
Bello Bio’s Research Team participates in both clinical and basic science studies. These research studies are designed to move the field of regenerative medicine forward with data that produces high level evidence.
Clinical trials are being primed for the following conditions using regenerative biologics with prospective, controlled, blinded, dose escalation protocols:
- Umbilical Cord Mesenchymal Stem Cells for Autism
- Umbilical Cord Derived Exosomes for Erectile Dysfunction
- Umbilical Cord Wharton’s Jelly for Knee Arthritis
- Umbilical Cord Mesenchymal Stem Cells for Chronic Kidney Disease
To date, Bello Bio has published the following research papers in peer reviewed journals, simply click on each paper to download:
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:
- US Food and Drug Administration (FDA)
- World Health Organization (WHO)
- European Union (in the EUDRALEX)
- UK Medicines & Healthcare Regulatory Agency (MHRA)
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:
- For structural tissue, processing that does not alter the original relevant characteristics of the tissue relating to the tissue’s utility for reconstruction, repair, or replacement;
- For cells or nonstructural tissues, processing that does not alter the relevant biological characteristics of cells or tissues.
The products manufactured at Bello Bio USA are only available for purchase by licensed healthcare professionals. Bello Bio places a current license on file for each customer.
Bello Bio products can not be purchased directly as Bellio Bio has an exclusive distributor contract with Regen, Bello does not handle medical licenses because Bello Bio only sells to Regen. Regen must handle this.
Bello Bio employs several molecular biologists. These individuals are key to the successful production of the clinical and research biologics in both the USA. 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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