The fraudulent companies that promise false cures for the patients are like a black eye to the pharmaceutical industry.
FREMONT, CA: Many companies are crediting FDA’s recent crackdown on stem cell clinics that tout treatment with no information or to back their claims. There are many clinics offering treatments that are not proven, and it should be a concern for the patients if the treatments involve stem cells or not. The main concern is the one related to loopholes in various legislative provisions among the medical and pharmaceutical products. In few cases, loopholes are a good thing, for instance, the one which enables a physician to use a patient’s material body parts to repair and restore function in other parts on their body, like the use of a skin graft.
Autologous Versus Allogeneic Treatments
The problem around the patients, who are donating their material which is called an autologous treatment, is that the options are very limited. For example, Patient who has suffered severe burns on their body might not have a healthy skin left to graft to the parts of the body. Even healthy patients are also cannot donate their material for the ones in need. Hence there is an alternative approach called allogeneic, which is often referred to as an off-the-shelf approach. This approach creates a product that can be used in multiple patients.
The Right Cell Donor
A pharma company will be introducing a stem cell trial of its stem cells in 448 patients who are suffering from osteoarthritis. The patients are treated with a cell therapy product, as it is a living thing; hence there had to be a human donor. The original donor provided the starting material for the manufacturing process around about eight years ago because an unlimited number of cells can be produced from the donation, the pharma company will not have to go back to the donor and collect their cells. The original donation was a little similar to giving blood, but the screening and consent process was very complicated. It is very important to ensure that the donors from whom the samples are collected are healthy and do not possess a history of certain infectious or contagious diseases.
Moreover, safety and efficiency are the primary requirements. Still, the pharma companies have to be able to tackle all these issues and manufacture the product at scale, in an economical manner.