Mar 07, 2019

https://www.worldhealth.net/news/new...G5MCXg_AqR6Oks

Texas is loosening stem cell treatment regulations, while the FDA and health authorities in other countries are moving in the opposite direction. This may open the door for a Houston based purveyor that has been treating patients abroad with mesenchymal stem cells for years to return.

On the east side of Cancun, Mexico the small private Hospital Galenia has been drawing people in who seek health treatments not sanctioned in other countries; however this is far from being the only medical tourism company operating out of Gamenia included among these is the Houston based Celltex Therapeutics.

Celltex offers stem cell therapies mostly to American customers, and claim be using the patient’s own mesenchymal stem cells to treat various diseases and conditions. Originally the company operated out of a laboratory site in Sugar Land, Texas, but had to cease treatments in Texas in 2013 after receiving a warning letter from the US FDA in 2012 stating that their patient derived cells being harvested/injected were considered drugs under US federal law thereby requiring clinical trials and regulatory approval; additionally the FDA stated the company was mishandling the cells, failing to keep them in sterile condition, and mislabeling containers.

Since 2013 Celltex moved its clinical operations to Mexico, and has been shipping ready to use MSCs in syringes to their clinic in Hospital Galenia. With the newly passed “Charlie’s Law” in Texas this may change, and the company may have the opportunity to resume treatments within Texas; the new law may allow Texas clinics to administer certain non-FDA-approved stem cell treatments to select patients such as the ones offered by the company.

The new stem cell law potentially sets up a state-federal conflict much like the one CBDs have experienced, as state laws are subordinate to federal FDA rules; meaning even though it may be legal at a state level it is still illegal on the federal level leaving many gray areas. Proponents of direct to consumer stem cell clinics could use the law as an opportunity to challenge federal rulings which could result in federal court cases.

According to a Celltex spokesperson the law is a step in the right direction, but still far from a law which would allow companies to provide high dose adult stem cell banking and therapy within the USA.

While many applaud the new law, many are also opposed to it and question the efficacy of such treatments, and bioethicists have voiced concerns regarding selling therapy before adequate evidence is in, citing without rigorous testing and oversight there are no guarantees such clinics will abide by rigorous laboratory practices, or that the treatments are not putting patients at risk in some cases. “In some cases unproven entities/therapies are scientifically implausible based on what is know about the biology,” says Sean Morrison stem cell biologist at the University of Texas.

Celltex treats 400-500 people a year using MSCs harvested from the patients’ own fat, which are purified, expanded, and frozen in Texas before being sent to Mexico to be infused back into the patient either intravenously or injected into the affected tissues. According to Gabriel Salazar most patients seek relief of inflammatory conditions such as arthritis. CEO David Eller says they have safely administered MSCS to upwards of 4,500 clients who have all had improvements ranging from minor to miraculous, without any problems. Going on to add “..clinical trials are a waste of patient time to wait another decade for costly trials as loved ones deteriorate, or we can do something about it now… doing nothing is the real risk..”

243 ongoing MSCs trials are listed at clinicaltrials.org, yet there still are no FDA approved therapies using MSCs for any condition, which are studying MSCs to develop standardized isolation methods, and to learn how they behave when injection into the body.

Anecdotal testimonies are abundant, however hard evidence is hard to come by. Many companies selling stem cell therapies often do not publish their studies in peer reviewed journals. Celltex thus far has one publication in 2017 documenting MSCs use in patients involving 2 subjects with a nervous disorder which suggests autologous adipose derived MSC treatment resulted in improvements of symptoms.

Celltex will be conducting its first clinical trial, and has been given the go ahead to start the trial in patients with rheumatoid arthritis and osteoarthritis by COFERPRIS in Mexico; Phase 2 studies will use the company’s protocols to generate cells in quantities not possible before in therapies for autoimmune, vascular, degenerative diseases, and injuries. The trial will measure QoL of patients prior and after therapy, while monitoring safety and toxicity, free of costs to the participants, according to a press release.

Celltex claims to use MD Anderson Flow Cytometry weekly to validate the cells are 100% patient derived MSCs, and that facility core staff independently conduct quality control and validation. However the facility says something else: Celltex has paid to use the public Flow Cytometry Facility since 2015 but no one from their facility does any independent assessments; records show Celltex as using the facility for 2 hours in November 2, 2017 and for on hour on January 18 and 19, 2018.

The new stem cell law in Texas has yet to come into effect as the state commissions are still developing the procedure of how the law will be implemented. The plan is for each stem cell treatment to be reviewed by an Independent Review Board, after a favorable review the treatment could then be administered in other institutions, according to Senator Paul Bettencourt.

Another new law in California requires direct to customer stem cell clinics to disclose their products are not approved by the FDA to all customers. To be a candidate under the Texas law a patient must have a severe or chronic disease, or be terminally ill; and treatment must be registered in a clinical database.

While it looks as if Texas is loosening regulations on stem cell treatments, the US FDA and authorities in some other countries are tightening, being more focussed on oversight and scrutiny of direct to consumer stem cell clinics. Recently the FDA has warned consumers about buying stem cells from clinics, and announced plans for better enforcements of federal laws and oversights. Health agencies in Canada, Australia, and India have all also recently announced higher levels of stem cell clinic regulations.

Although this is a positive step forward, the take away seems to be to do your due diligence, research thoroughly as a legitimate company will happily provide you details to investigate, and as always let the buyer beware.

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