A Controversial Law Helps Stem Cell Firms to Administer Controversial Treatments

Hospital Galenia

Hospital Galenia, situated along the east side of Cancun, Mexico, is actually quite a popular facility in the vicinity. It is a popular site for many people because patients who want to get unsanctioned treatments go there.
Hospital Galenia is a medical facility that administers drugs that are not sanctioned by the U.S. Food and Drug Administration and other similar government agencies worldwide.

Look, I get that people want to be treated by their condition and the medicines that we have today may not provide a true cure to what ails them. However, getting unsanctioned treatments could potentially be fatal or would lead to further complications.

That being said, a Houston-based company, known as Celltex Therapeutics, offer stem cell therapies to American customers (and some customers with other ethnic origins as well).

According to a representative of the company, Celltex mainly focuses on extracting the patient’s own Mesenchymal Stem Cells to help treat a wide variety of diseases, including renal failure, amyotrophic lateral sclerosis (ALS), and Chronic Obstructive Pulmonary Disease or COPD.

The company used to administer stem cells that were taken out of their own laboratory in Sugar Land, Texas. However, their operation ceased to exist back in 2013 when the FDA sent the company a warning.

The warning states that the cells that were derived from prior patients- using them for deriving and administering stem cells- is considered to be drugs under the US Federal law. This would then implicate the administration of these cells would require further studies and clinical trials and only then will it receive regulatory approval.

Instead of doing that route, Celltex would ship their stem cells to Hospital Galenia since the medical facility is located outside of U.S. borders. However, a new Texas legislation could potentially allow Celltex to operate within country grounds.

The law in question is known as the “Charlie’s Law”, and it states that all of the Texas clinics will be allowed to administer non-FDA approved stem cell treatments, but only to a select few.

Although Celltex and the politicians that have ties with the company- along with people who want to receive the stem cell treatments- are rejoicing with this news, scientists and bioethicists have concerns regarding the selling of unsanctioned therapies that have no prior evidence of its potency and safety.

Is the Treatment Truly Effective?

According to Celltex, the company was able to administer the Mesenchymal Stem Cells to more than 4000 patients already. The stem cells are proven to be safe (at least, according to the company) because they are derived from the patient’s own body (particularly from their belly fat).

The stem cell treatments are usually administered to patients who are seeking relief for their chronic inflammatory conditions such as Arthritis, for example.

Although anecdotal evidence may suggest that the stem cell treatments may have improved their patients’ conditions, it would still not be the case in the scientific sense since the company doesn’t create clinical evidence or reports.

Scientists and bioethicists urge Celltex to create a study of their own and present the findings to the medical community whether or not their stem cell treatments are effective.