Giostar stem cell clinic chain review, red flags, & lawsuit

Some unproven stem cell clinics like one called Giostar have multiple locations sprouting up. To me the concern with that spreading is the potential of multiplying risks to consumers. It can be hard to get a clear take on what these clinics are doing too.

What's in this article

What is Giostar? | Giostar review | Is Giostar legitimate? | Deven Patel & Anand Srivastava | More concerns | Lawsuit Complaint | Overall take home | References

The goal of today's article is to give an overview and fact-check of Giostar. As a stem cell biologist who follows clinical efforts, I have major doubts about this firm's offerings and claims. As we with other such firms I see several red flags but this company is unique in some ways.

What exactly is Giostar?

Giostar is a stem cell clinic chain selling unproven therapies. It has locations in India, Mexico, the US, and other countries. I use the word "unproven" for a reason here. As a stem cell biologist in my opinion there isn't good clinical trial evidence to back up their offerings.

The company name is an acronym standing for "Global Institute of Stem Cell Therapy and Research." In reading that I have to wonder: how much clinical research are they doing? Another name I see a lot is GIOSTAR USA.

While Giostar lists publications on their website, I don't recognize some of the journals. Looking on Pubmed, I only see five publications listed for the firm. Pubmed doesn't list some more obscure journals.

Giostar review: thumbs down

Publications can be a good thing. Most clinic's have none. But as to Giostar, in my view their papers do not provide the kind of strong evidence needed to support use of cell therapies for specific conditions in people.

They sell several kinds of supposed treatments including MSCs or mesenchymal cells. I also see mention of umbilical cord mesenchymal cells. They market MSCs from bone marrow and blood. Claims are made for many health conditions.

A Clinicaltrials.gov search found no listings for Giostar. On the firm's website they say they are gearing up for several trials via the FDA. They mention COVID, universal RBCs, diabetes, and a cancer vaccine. We'll see if any of these appear later on Clinicaltrials.gov.

They have multiple US locations including San Diego and Chicago.

It's not entirely clear what's sold in the US vs. international locations. This makes it difficult to evaluate FDA compliance.

Perhaps their biggest news here in the US was that the FDA gave them a compassionate use clearance for stem cells for COVID-19. However, in my view the FDA more generally during that earlier period of the pandemic made some questionable decisions related to COVID-19 and cell therapies. I wonder if politics played a role.

Is Giostar legitimate?

If you search for Giostar on Google, one of the "People also ask" questions the search engine puts near the top is this question about legitimacy. Somehow the stem cell promotion site Bioinformant is Google's idea of the authorities there to answer the question. I've noted in past posts that Bioinformant promotes Giostar heavily on their website. They also promote other unproven clinics.

So what's the answer to the legitimacy question? I guess it depends on your definition of legitimate. Overall, I don't believe there is sufficient biomedical evidence that Giostar's offerings are proven safe and effective. The data don't even come close to the standard I'd want to see.

How much does Giostar cost? On the web I saw that Giostar cost ranges from $5,000-$18,000. The price tag likely depends on what you're having done and at which clinic. So it could be a waste of money too.

Deven Patel & Anand Srivastava

Who is the leadership behind Giostar?

Deven Patel is the CEO and President of the firm. Anand Srivastava, MS, Ph.D. is the Chairman and CSO.

It seems that Patel and Srivastava co-founded the firm.

I don't see any science or medicine-related background listed for Patel on the company website or elsewhere. It's not that unusual for CEOs in the biotech world to be business people rather than scientists or physicians.

What about Srivastava? He was a visiting researcher at the Burnham institutefrom 2009-2012. He also apparently did a brief stint as a researcher at the Salk prior to going to the Burnham. This is all per the LA Times.

More concerns from LA Times

Speaking of which, Michael Hiltzikover at the LA Times also reported several concerns about Giostar and its leadership. From the piece:"Now let's turn to Srivastava's credentials, which are the bedrock of Giostar's assertion of stem-cell treatment leadership. Patel acknowledged in an email that some of Srivastava's descriptions of his prior academic appointments have been exaggerated. They include his claims on the company website to have been an associate professor in the department of cellular and molecular biology at UCLA's medical school, an associate professor at UC Irvine medical school, and an assistant professor at UC San Diego medical school."

Hiltzik goes on to note other misstatements from Giostar in the past.

"Giostar has touted its relationship with prominent experts in stem-cell science in California and abroad. Among them are Evan Snyder, director of the Center for Stem Cells and Regenerative Medicine at the Sanford Burnham Prebys Medical Discovery Institute in La Jolla, and Ewa Carrier, an expert in blood and marrow transplantation formerly at UC San Diego. Both have been listed on Giostar's website as members of its scientific and medical advisory board.

But both say they have no connection to Giostar and should never have been listed as board members."

I see that as a big problem.

In a later LA Times article, Hiltzik also dinged the firm related to clinical trial claims and the compassionate use/expanded access program. From Hiltzik, "there doesn't seem to be such a thing as a clinical trial conducted subject to the expanded access program."

Giostar Lawsuit Complaint

My research found another reason for concern. A California customer filed suit against Giostar in 2020. The Giostar lawsuit, Mendez v. Global Institute of Stem Cell Therapy and Research USA et al., makes several allegations. Mendez is reportedly a cancer survivor. From the Classaction.org item discussing the legal complaint:

"According to the 42-page lawsuit, however, the plaintiff, who was 29 when she was diagnosed with the treatable form of cancer, took a preventable turn for the worse after the defendants administered stem cell treatment without first requiring the woman to undergo chemotherapy or radiation to kill the cancer cells, or properly matching injected cells with cells in the plaintiff's body. The plaintiff claims that following treatment with the defendants, her cancer progressed from Stage II to Stage IV within months, leading a medical expert to inform the woman "it was unlikely she would survive for more than a year."

Doing a Pacer court search, the case still seems to be pending. It was reassigned a couple of times to different judges. I'm not 100% sure though.

Overall take-home

Giostar is unlikely to live up to its claims about stem cell treatments.

There are also going to be risks.

Overall, in my view, the costs and risks aren't worth it given the red flags and lack of data on the cells actually working.

References

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