Concerns over stem cell clinics allegedly causing loss of sight or other vision problems have been increasing in 2016. If this is in fact happening, the extra sad part of this is that will some clinics have claimed that they are doing the opposite: enhancing vision in patients.

What are the worries?

Earlier this year a publicly-traded stem cellular business in Florida called U. S. Stem Cellular, Inc. was sued   together with other defendants by a former customer Elizabeth Noble, alleging damage done via an experimental stem cell “ treatment” for vision. That case appears settled.

SEC filings by U. S i9000. Stem Cell also disclosed  another suit against all of them involving a different plaintiff, Patsy Bade. Note that U. S i9000. Stem Cell Inc. used to be called Bioheart, Inc., includes a subsidiary called U. S. Stem Cell Clinic LLC, and that Kristin Comella is a leader of U. S i9000. Stem Cell.

From the SEC Filing simply by U. S. Stem Cell:

“ On September 17, 2015, a product liability lawsuit had been filed in Broward County, specifically Patsy Bade sixth is v. Bioheart, Inc. US Stem Cell Clinics LLC, Aleiandro Perez, ARNP, and Shareen Greenbaum, M. D., and November 30, 2015, a product liability lawsuit was submitted in Broward County, specifically Elizabeth Noble v. Bioheart, Inc. US Stem Cell Clinics LLC, Aleiandro Perez, ARNP, and Shareen Greenbaum, M. D. During the 6 months ended June 30, 2016, both matters settled from the Company’ s insurance policy with no additional cost to the Business. ”

I’ ve been asking yourself about the  circumstances of  Bade’ s suit, which usually like the Noble case was mentioned as being  within Broward County, but the Bade case didn’ t show on their county court website. As a result, I did other research because time permitted. hollywood-eye-institute

court search in the adjacent Miami-Dade Region using the search term “ Bioheart”, again the old name associated with U. S. Stem Cell, Inc., revealed that Bade had filed a lawsuit in that county against some of the exact same parties involved in the Noble case.

Bade provides apparently settled with US Stem Cell, Inc., but the best way as I could tell as a non-attorney she has not so much settled with  Dr . Shareen Greenbaum and her office the Hollywood Eye Institute.

Exactly what did Bade claim had happened?

She  alleged that a stem cell treatment she obtained caused her to go blind, an allegation that  continues to be unconfirmed to my knowledge. This case raises pressing queries though. I recommend reading the   amended problem document   if you want to at least try to learn more. It  is publicly available on the court site and I have got posted it here.   U. S. Stem Cellular, Inc. and its leader Kristin Comella are mentioned thoroughly in the amended complaint.

Comella made the public comment  at the second FDA stem cell conference in September on the FDA stem cell draft guidances, speaking  about the beneficial use of originate cells and for less government oversight of stem tissue:

“ The government should not regulate the body. I’ m Kristin Comella, and I will always stand up designed for patient rights, ” said Kristin Comella, chief technology officer for Florida-based U. S. Stem Cell, one more prominent stem cell treatment provider. ”

The amended complaint in the Bade suit listings many allegations including some listed below verbatim, but they are certainly not verified  so be cautious in interpretation:

  • “ U. S. Stem Cell, Inc. was  working a business for profit, under the guise of a clinical analysis trial. ”
  • “ Ms. Comella is not really a physician, and, at all times relevant to this  lawsuit, she failed to have any degree in medicine or cell the field of biology.   Nonetheless, Ms. Comella touted herself as an professional in adipose stem cell  research and actively took part in U. S. Stem Cell, lnc. ’ s i9000 stem cell  procedures. ”
  • “ Mister. Perez, who was  supposedly trained as a doctor within Cuba, was routinely introduced as a  physician in order to prospective U. S. Stem Cell Clinic patients. ”
  • “ Dr . Greenbaum had little or no encounter in conducting  medical research or clinical trials together no experience with stem cells.   Ms. Comella understood this, but advised that experience was not necessary. ”
  • “ Defendant Dr . Greenbaum Begins Performing Originate Cell Therapy  Surgeries and Realizes the Clinical Test to be a Scam. ”
  • “ Dr .   Greenbaum did nothing to communicate her concerns concerning the clinical  trial, nor did she do anything to deter Ms. Bade from going forward with  this procedure. ”
  • “ Following the surgery, Ms. Bade’ s eyesight worsened drastically  and she is now legally blind. ”

What’ s actually going on right here?

Things are not yet entirely crystal clear.

The amended complaint is all we have to embark on so far though as the people involved in the case aren’ to opening up about it. The  main attorney listed in that record as representing Bade, Andrew Yaffa, said that he has been unable to comment, and my emails (one 2 weeks ago based on the FDA meeting and another 2 weeks back based on the Bade case) to Comella with a few queries have not been answered. If anyone else  knows of comparable cases or more facts on these cases, the community might benefit from knowing about them.

Comella did earlier  give an interview to NPR exactly where she reportedly acknowledged two negative eye outcomes plus said U. S. Stem Cell was no longer performing vision treatments:

Comella acknowledges that 2 of her clinic’ s patients suffered detached retinas after getting stem cells injected into their eyes. Because of this, the clinic has stopped treating eye conditions. Yet otherwise, Comella says, the clinic has had no severe problems. It offers stem cell treatments for a host associated with conditions including diabetes, spinal cord injuries and congestive center failure. ”

I’ lmost all leave it for readers to go through the amended problem document and draw their own conclusions, but the claims shown there in my opinion raise serious questions and the stem cellular community needs to learn more about this situation to better understand what happened plus help patients avoid negative outcomes in the future.

Other cases of alleged blindness or eyesight problems caused by clinics

With Respectable also alleging a similar outcome as Bade, and Dr . Thomas Albini’ s presentation at the first of two recent FDA conferences on stem cells   mentioning three ladies blinded by a business in Florida, it is reasonable in order to ask, “ were Bade and Noble two from the three women that Dr . Albini was alluding in order to? ”   I emailed Dr . Albini about a couple weeks ago asking for clarity, but he has not replied up to now so I’ m not sure. Unless I missed this, Albini did not mention the business(es) involved by title in his talk at the FDA meeting.

Also i got to wondering about the identity of the third woman who had been also allegedly blinded according to Albini and where the lady got stem cells. I couldn’ t find details on that situation. In addition , it was reported that a guy at the second FDA stem cell meeting had an indication alleging that  he had been blinded by a stem cellular clinic involved in the SCOTS study, a different clinical experiment making use of stem cells for vision loss.   This is a recent update I did on the SCOTS test and the patient’ s allegations.

Dr . Albini and colleagues further published a case survey paper in June on a man exactly who had retinal detachment apparently caused by a stem cell hair transplant, but it’ s not clear  what the circumstances had been of that case or if there are any link  to people cases mentioned earlier in this post.

What goes on next?

We shouldn’ t allow this concerning situation with clinics detract from the thorough and exciting research ongoing in bona fide FDA-approved come cell clinical trials for vision loss, but all of us also cannot ignore the potentially extremely serious alleged difficulties with vision in the stem cell clinic arena either. The particular FDA already should be actively  looking into these situations plus importantly let the public know quickly what is going on, but it’ s unclear whether they  are doing or will do anything at all. Importantly,   in the interview I did with Comella a year ago here  she said that the FOOD AND DRUG ADMINISTRATION had visited her company in December 2014, but evidently did not take any action.

Stay tuned to get more developments in this area.

Note:   neither  U. S. Stem Cell, Inc.   and  U. S. Stem Cell Clinic   nor the individuals/other businesses mentioned in the suit or in the amended complaint in the settled case are already found liable for anything that was alleged, the allegations stay unconfirmed,   and part of this case is to our knowledge still pending.

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