Category Archives: Stem Cell Clinic


Study points to dangers in unproven stem cell treatments in local clinics – Miami’s Community Newspapers

Three South Florida women suffered serious loss of vision soon after receiving stem cell treatments for age-related macular degeneration (AMD) at a Broward clinic in 2015, according to a study published today recently in the New England Journal of Medicine.

The retinal detachments, bleeding in the eyes and other blinding complications in these three patients raise concerns about stem cell clinics that charge patients for their services and that lack clinical data to support their practices, said Thomas Albini, MD, associate professor of clinical ophthalmology at Bascom Palmer Eye Institute and co-author of the study.

Albini said the three patients ages 72, 78 and 88 were concerned about losing their independence, including the ability to drive, due to AMD, a disorder that involves the gradual loss of the eyes photoreceptor cells and the leading cause of vision loss among elderly patients in the United States.

Patients seeking stem cell treatments for medical problems should only consider a carefully controlled clinical trial at an academic medical center, Albini said. Paying thousands of dollars to a local clinic for an unproven stem cell treatment as these patients did is extremely risky with a low probability of a successful outcome.

Five other Bascom Palmer physicians were co-authors of the study, Vision Loss after Intravitreal Injection of Autologous Stem Cells for AMD, in the journal: Ajay E. Kuriyan, MD; Justin H. Townsend, MD; Marianeli Rodriguez, MD, PhD; Philip J. Rosenfeld, MD, PhD; and Harry W. Flynn Jr., MD. Other co-authors were faculty members from the University of Rochester Medical Center; Dean McGee Eye Institute, University of Oklahoma; Center for Sight, Sarasota, and Byers Eye Institute, Stanford University.

In the study, the Bascom Palmer ophthalmologists discussed how the Broward clinic (its name was not disclosed) first harvested stem cells from the adipose fat tissues of the three patients and then injected the cells into both eyes of each patient.

Within 36 hours of their treatment at the Broward clinic, two of the three patients sought emergency care at Bascom Palmer for serious blinding conditions including ocular hypertension, vitreous hemorrhage, retinal detachment, and/or lens dislocation. Although the patients had suffered only moderate vision loss prior to their treatment, a year later their visual acuities ranged from 20/200 to total blindness.

While numerous stem cell therapies for medical disorders are being investigated at research institutions with appropriate regulatory oversight, many stem cell clinics are treating patients without that oversight and with potentially little concern for patient safety, Albin isaid. In this instance, these patients paid $5,000 each for a procedure that had never been studied in a clinical trial for possible improvement of vision.

Albini said the patients might have developed vision loss from retinal or optic nerve toxicity from the injected stem cells, enzymes or other materials, or from elevated intraocular pressure (IOP), which damages the optic nerve.

Several cellular therapy approaches are now being investigated by U.S. Food and Drug Administration (FDA) registered and Institutional Review Board (IRB) approved clinical trials, according to the study.

As of Nov. 2, 2016, at least 13 trials were registered on ClinicalTrials.gov studying the role of intravitreal injections of various stem cell populations. However, Albini cautioned that not every trial registered on the site has been approved by an IRB or the FDA.

Some clinics are claiming that treatments using the patients own stem cells dont require FDA oversight or clinical trials, even though there is no evidence the treatments are safe or effective, he said. Almost all legitimate research is funded by an institution or company with an established protocol, lots of pre-clinical data and extensive pre-trial and post-trial evaluations.

For information on Bascom Palmer Eye Institute, contact Marla Bercuson at 305-326-6190 or send email to mbercuson@med.miami.edu, or visit http://www.bascompalmer.org.

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Study points to dangers in unproven stem cell treatments in local clinics - Miami's Community Newspapers

Animal Clinic of Council Bluffs and Glenwood Veterinary Clinic Offer Stem Cell Therapy for Pets – P&T Community

Animal Clinic of Council Bluffs and Glenwood Veterinary Clinic Offer Stem Cell Therapy for Pets
P&T Community
COUNCIL BLUFFS, Iowa, March 26, 2017 (GLOBE NEWSWIRE) -- MediVet stem cell therapy, offered at Animal Clinic of Council Bluffs and Glenwood Veterinary Clinic, provides pets and owners with a way to address health concerns in cats and dogs.

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Animal Clinic of Council Bluffs and Glenwood Veterinary Clinic Offer Stem Cell Therapy for Pets - P&T Community

Sunrise stem cell clinic behind blindness cases is largely … – Concord Register

U.S. Stem Cell Clinic is in the spotlight after three patients reportedly lost their eyesight following procedures here.

The Sunrise facility offers stem cell treatments for a range of diseases and chronic disorders and yet it has no medical facility license.

Heres what you might not know: It doesnt need one.

The facility falls under a regulatory loophole. Regulators with Floridas Agency for Health Care Administration, which licenses health care facilities like hospitals and rehabilitation clinics, say they have no authority over stem cell operations. Neither does the Florida Department of Health, which only has regulatory power over personnel like licensed doctors and nurses working in these facilities.

Both state agencies say that authority lies with the . Yet even here, guidelines for adipose stem cells (harvested from the clients themselves) are unclear.

The FDA could not discuss whether U.S. Stem Cell has faced or could face a potential investigation, spokeswoman Andrea Fischer said. She said the agency is working on guidelines that will clarify how human cells, tissues and products based on them should be regulated. The agency also been posting consumer warnings for years alerting patients to ask if theyre going to be part of an FDA-regulated clinical study.

We really dont know what standards these [clinics] have to conform to, said Dr. Thomas Albini, an associate professor of clinical ophthalmology at the University of Miamis Bascom Palmer Eye Institute. He recently co-authored a report in the New England Journal of Medicine about the U.S. Stem Cell cases.

If someone were licensed, that license would be on the line, he said.

There were no sanctions against the private, for-profit clinic after three women, in their 70s and 80s, lost their sight in 2015 following procedures where they had fat cells liposuctioned out of their belly area and injected into both of their eyes. The women had macular degeneration, a common disorder which eventually leads to blindness. They each paid $5,000 for the procedure.

Two traveled from out of state, and one came from Floridas west coast. At least two went to U.S. Stem Cell because of clinical trials listed on clinicaltrials.gov, a database managed by the National Institutes of Health, said Albini, who along with a Bascom Palmer colleague treated two of the patients shortly after their clinic visits. Their complications included detached retinas, optic nerve damage and eye hemorrhages.

The clinicaltrials.gov posting now says the study was withdrawn prior to enrollment.

On its website, the Sunrise facility says its team of medical researchers and practitioners can draw stem cells from their clients own fat tissue and reinject them into their bodies. There, the cells regenerative power can beat back medical disorders like Parkinsons, congestive heart failure and rheumatoid arthritis, according to the company.

In a written statement, the company, originally called Bioheart, said neither the clinic nor its affiliate, U.S. Stem Cell Inc., is currently treating eye patients.

Since 2001, our clinics have successfully conducted more than 7,000 stem cell procedures with less than 0.01% adverse reactions reported, the statement said. We are unable to comment further on specific cases due to patient confidentiality or legal confidentiality obligations.

The company declined to produce published papers about its research or any trials it had conducted.

Albini questions whether a true trial ever existed. Typically, participants of a clinical trial dont pay for treatment and continue to be monitored through followup appointments. Neither was the case for the three women who went to U.S. Stem Cell Clinic, Albini said.

He also said no legitimate researcher would do an experimental procedure, with no clinical track record, on both of a patients eyes, risking blindness. These people were way out of their league, he said.

Two of the women sued for negligence, failure to warn, and allegations regarding how the product manufactured from their own bodies was defective. Both settled, and their cases were dismissed. Attorneys for U.S. Stem Cell argued that the cases, as filed, involved medical negligence and, as such, needed to be refiled to conform with state law, according to court records.

Attorney Benjamin Bedard, who handled both dismissal filings, could not be reached for comment.

Albini said the FDA had him speak at a workshop in September regarding its concerns about experimental, unlicensed stem cell clinics.

My understanding is its a billion-dollar industry already, he said. We dont have great treatments for people with these conditions. There are people who want tomorrows medicines today and are willing to pay for it.

Staff researcher Barbara Hijek contributed to this report.

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Scientists know how to grow human heart tissue – Institute …

Scientists used stem cells to grow human heart tissue that contracted spontaneously in a petri dish marking progress in the quest to manufacture transplant organs.

A team from the University of Pittsburgh, Pennsylvania, used induced pluripotent stem (iPS) cells generated from human skin cells to create precursor heart cells called MCPs. iPS cells are mature human cells reprogrammed into a versatile, primitive state from which they can be prompted to develop into any kind of cell of the body. The primitive heart cells created in this way were attached to a mouse heart scaffold from which the researchers had removed all mouse heart cells, they wrote in the journal Nature Communications.

The scaffold is a network of non-living tissue composed of proteins and carbohydrates to which cells adhere and grow on. Placed on the 3D scaffold, the precursor cells grew and developed into heart muscle, and after 20 days of blood supply the reconstructed mouse organ began contracting again at the rate of 40 to 50 beats per minute, said a University of Pittsburgh statement.

It is still far from making a whole human heart, added senior researcher Lei Yang. Ways have to be found to make the heart contract strongly enough to pump blood effectively and to rebuild the hearts electrical conduction system. However, we provide a novel resource of cells iPS cell-derived MCPs for future heart tissue engineering, Yang told AFP by email. We hope our study would be used in the future to replace a piece of tissue damaged by a heart attack, or perhaps an entire organ, in patients with heart disease.

According to the World Health Organisation, an estimated 17 million people die of cardiovascular ailments every year, most of them from heart disease. Due to a shortage of donor organs, end-stage heart failure is irreversible, said the study. More than half of patients with heart disease do not benefit from drugs. Heart tissue engineering holds a great promise based on the reconstruction of patient-specific cardiac muscle, the researchers wrote.

Last month, scientists in Japan said they had grown functional human liver tissue from stem cells in a similar process. Creating lab-grown tissue to replenish organs damaged by accident or disease is a Holy Grail for the pioneering field of stem cell research. Until a few years ago, when iPS cells were created, the only way to obtain stem cells was to harvest them from human embryos. This was controversial because it required the destruction of the embryo, a process to which religious conservatives and others object.

Source: http://news.sudanvisiondaily.com

As the Chief Doctor of the Institute of Cell Therapy, Y.V.Gladkikh, MD, PhD, Dr. med. sc. commented: In addition to laboratory success in obtaining the functional cardiac tissue, currently there is evidence of successful implantations of heart valves and blood vessels fragments, grown from stem cells, to patients. And in 2012, the Ministry of Health of Ukraine officially approved method of treatment of critical limbs ischemia with the use of cell preparation Angiostem, developed by the biotechnological laboratory of the Institute of Cell Therapy.

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Scientists know how to grow human heart tissue - Institute ...

Sunrise stem cell clinic behind blindness cases is largely unregulated – Sun Sentinel

U.S. Stem Cell Clinic is in the spotlight after three patients reportedly lost their eyesight following procedures here.

The Sunrise facility offers stem cell treatments for a range of diseases and chronic disorders and yet it has no medical facility license.

Heres what you might not know: It doesnt need one.

The facility falls under a regulatory loophole. Regulators with Floridas Agency for Health Care Administration, which licenses health care facilities like hospitals and rehabilitation clinics, say they have no authority over stem cell operations. Neither does the Florida Department of Health, which only has regulatory power over personnel like licensed doctors and nurses working in these facilities.

Both state agencies say that authority lies with the U.S. Food and Drug Administration. Yet even here, guidelines for adipose stem cells (harvested from the clients themselves) are unclear.

The FDA could not discuss whether U.S. Stem Cell has faced or could face a potential investigation, spokeswoman Andrea Fischer said. She said the agency is working on guidelines that will clarify how human cells, tissues and products based on them should be regulated. The agency also been posting consumer warnings for years alerting patients to ask if theyre going to be part of an FDA-regulated clinical study.

We really dont know what standards these [clinics] have to conform to, said Dr. Thomas Albini, an associate professor of clinical ophthalmology at the University of Miamis Bascom Palmer Eye Institute. He recently co-authored a report in the New England Journal of Medicine about the U.S. Stem Cell cases.

If someone were licensed, that license would be on the line, he said.

There were no sanctions against the private, for-profit clinic after three women, in their 70s and 80s, lost their sight in 2015 following procedures where they had fat cells liposuctioned out of their belly area and injected into both of their eyes. The women had macular degeneration, a common disorder which eventually leads to blindness. They each paid $5,000 for the procedure.

Two traveled from out of state, and one came from Floridas west coast. At least two went to U.S. Stem Cell because of clinical trials listed on clinicaltrials.gov, a database managed by the National Institutes of Health, said Albini, who along with a Bascom Palmer colleague treated two of the patients shortly after their clinic visits. Their complications included detached retinas, optic nerve damage and eye hemorrhages.

The clinicaltrials.gov posting now says the study was withdrawn prior to enrollment.

On its website, the Sunrise facility says its team of medical researchers and practitioners can draw stem cells from their clients own fat tissue and reinject them into their bodies. There, the cells regenerative power can beat back medical disorders like Parkinsons, congestive heart failure and rheumatoid arthritis, according to the company.

In a written statement, the company, originally called Bioheart, said neither the clinic nor its affiliate, U.S. Stem Cell Inc., is currently treating eye patients.

Since 2001, our clinics have successfully conducted more than 7,000 stem cell procedures with less than 0.01% adverse reactions reported, the statement said. We are unable to comment further on specific cases due to patient confidentiality or legal confidentiality obligations.

The company declined to produce published papers about its research or any trials it had conducted.

Albini questions whether a true trial ever existed. Typically, participants of a clinical trial dont pay for treatment and continue to be monitored through followup appointments. Neither was the case for the three women who went to U.S. Stem Cell Clinic, Albini said.

He also said no legitimate researcher would do an experimental procedure, with no clinical track record, on both of a patients eyes, risking blindness. These people were way out of their league, he said.

Two of the women sued for negligence, failure to warn, and allegations regarding how the product manufactured from their own bodies was defective. Both settled, and their cases were dismissed. Attorneys for U.S. Stem Cell argued that the cases, as filed, involved medical negligence and, as such, needed to be refiled to conform with state law, according to court records.

Attorney Benjamin Bedard, who handled both dismissal filings, could not be reached for comment.

Albini said the FDA had him speak at a workshop in September regarding its concerns about experimental, unlicensed stem cell clinics.

My understanding is its a billion-dollar industry already, he said. We dont have great treatments for people with these conditions. There are people who want tomorrows medicines today and are willing to pay for it.

Staff researcher Barbara Hijek contributed to this report.

dlade@sunsentinel.com or 954-356-4295

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Sunrise stem cell clinic behind blindness cases is largely unregulated - Sun Sentinel

Abstracts: Stem Cells, Selfies, Whales, and More – Undark – Undark Magazine

Unregulated, for-profit stem cell clinics might be the next snake oil salesmen. Three women went blind following injections of stem cells extracted from liposuction treatments in a clinic in Florida. Though they paid for the treatment, they were led to believe that they were participating in a government-approved clinical trial. (New York Times)

Scientists used to think of groups of 10 to 20 humpback whales as large, but groups of up to 200 have been spotted off the coast of South Africa.

Visual by iStock.com/YinYang

Its better to have cystic fibrosis in Canada. More efficient lung transplant allocation, high-fat diets, and ultimately more comprehensive insurance increases the average life expectancy of Canadians living with the genetic disorder. (STAT)

Trumps first budget proposal would include a nearly 20 percent cut to the NIH budget and eliminate the Fogarty International Center, an organization dedicated to building partnerships with health researchers scientists in other countries. (Washington Post)

Humpback whales are also organizing at unprecedented rates. Researchers report huge pods of the usually solitary whales congregating around South Africa at a time of the year when the whales are usually feeding in Antarctica. (Popular Science)

Despite typhoons, rooftop farming and self-grown organic foods are taking off in Hong Kong. (The New Yorker)

A study in the New England Journal of Medicine demonstrates that patient-specific, induced pluripotent stem cells are safe for transplant into eyes, but are still far from effective or affordable. (Science)

NASA released satellite images detailing green slush ice around the Granite Harbor in Antarctica. The presence of so much phytoplankton in an icy region has worrisome implications for algal blooms in the spring. (The Huffington Post)

Startups and health care providers are increasingly looking for ways to standardize the selfie. By providing patients with a color card to include in photos of their urine sample, pregnancy pre-eclampsia and chronic kidney conditions are caught earlier. (The Economist)

In an effort to curb prescription opioid abuse, Endo Pharmaceuticals reformulated Opana into crush-resistance capsules. The new capsules are much easier to dissolve, leading to a rise in injection and subsequent HIV and Hepatitis C outbreaks. An FDA advisory panel concluded risks outweighed the benefits of prescribing Opana. (NPR)

And finally, a look at how the chemistry of how lithium-ion batteries turn into skin-searing firebombs. (Wired)

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Abstracts: Stem Cells, Selfies, Whales, and More - Undark - Undark Magazine

US Stem Cell Inc (OTCMKTS:USRM) Still Looks Like A Winner … – Insider Financial

At the beginning of March, we highlighted US Stem Cell Inc (OTCMKTS:USRM) as being one to watch. The company is a stem cell player in the US, and we argued that its PPS was not accurately reflecting its potential. We linked to this presentation, given by CEO Kristin Comella, and recommended watching as a very concise, but relevant, primer on the companys operations.

Our concern, and the primary risk we associated with the company at this stage, was rooted in opacity surrounding the companys lead quants. Revenue figures were unclear at that point, as was cash holding and burn, and this made it difficult to justify anything more than a punt exposure from a risk reward perspective.

Well, since our coverage, two things have happened. The first, serves to alleviate much of the opacity, and in doing so, mitigates a substantial portion of the risk side of the equation. The second is what markets seem to be paying attention to, and has induced the opposite impact to that which we mightve expected if just the first event hit press.

Heres a look at both factors, and how they play into the companys attraction as a long term exposure going forward.

So, first, the good news.

On March 15, US Stem Cell put out financial results detailing full year 2016, and offered some perspective against the counterpart figures from the same period a year earlier. Based on the numbers, revenues increased from $2.2 million in 2015 to $3.03 million in 2016 a 38% climb. Current liabilities decreased from $8 million to $6 million between end 2015 and end 2016, a 24% decline. Operating expenses decreased, despite a top line increase, by 16.5%. Net loss came in at $1.15 million for 2016, versus $2.6 million a year earlier. Additionally, the company ended the year cash positive, at $108.5K, versus cash negative a year earlier, at $844K.

So, things are moving in the right direction, and weve now got some solid indication of what the company generates annually numbers on which we can start to base some sort of valuation. Things look good, right?

Not so fast.

Heres the second of our developments, and it comes in the form of an article seemingly borne out of the AP, but that is currently doing the rounds across all the major business and healthcare news networks, detailing the blinding of three women on the back of treatment at a stem cell clinic in Florida.

The exact details are unclear, but these women are reported to have been left either blind or partially blind on the back of retinal detachment post therapy and and heres the important part the treatment center they attended is a US Stem Cell center.

Right off the bat, this doesnt look great. In our eyes, however, this is nothing more than a hit piece. The company has conducted more than 7,000 stem cell procedures with less than 0.01% adverse reactions reported. Sure, the piece states this fact, but it does so after basically accusing Comella and her team of blinding three women through unapproved stem cell procedures.

Anyway, whatever the underlying truth (and motive) of the piece, its this, as opposed to the numbers and the companys 99.9% safety record that markets are focusing on. We see this as an opportunity one to get in at a discount ahead of US Stem Cells fortunes reversing and the company revaluing to reflect its true potential as both a company, and a player in the stem cell sector in the US.

With buyout rumors also floating around, and the companys lead clinical asset and technology MyoCell on the verge of FDA fast track designation approval in the US, theres plenty of potential catalysts near term to get this thing moving towards said revaluation.

We will be updating our subscribers as soon as we know more. For the latest updates on USRM, sign up below!

Disclosure: We have no position in USRM and have not been compensated for this article.

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US Stem Cell Inc (OTCMKTS:USRM) Still Looks Like A Winner ... - Insider Financial

At 6th Annual Clinical Trial Supply New England 2017 Conference in Boston Asymmetrex Introduces A First Specific … – Benzinga

On March 8-9 in Boston, stem cell medicine biotechnology start-up Asymmetrex led attendees at the 6th Annual Clinical Trials Supply New England 2017 conference in discussions about the need for quality controls for the supply of tissue stem cells used for treatments in either FDA-approved clinical trials or unregulated private stem cell clinics. Though these two stem cell treatment settings are often contrasted regarding their safety and effectiveness, Asymmetrex stressed that patient care and research progress is compromised in both because of the lack of essential quality control tests for the number and quality of transplanted tissue stem cells.

Boston, MA (PRWEB) March 14, 2017

At the 6th Annual Clinical Trials Supply New England 2017 conference, held in Boston from March 8-9, James Sherley, M.D., Ph.D., director of Asymmetrex, led discussions that evaluated the quality of U.S. supplies of stem cells used in clinical trials compared to private stem cell clinics. Private stem cell clinics have been criticized for not employing research standards that are necessary to establish the therapeutic effectiveness of treatments with statistical confidence. In part because of this difference in practice, they are also often accused of making unproven claims about the effectiveness of their therapies.

Sherley presented comparisons of key operational elements to argue that, given good intent in both settings, the two different settings of stem cell treatments had both distinct and shared shortcomings. He noted, however, that the most significant shortcoming, which stem cell clinical trials and private stem cell clinics share, was perennially overlooked.

Based on the number of reported stem cell clinical trials and private stem cell clinics, Sherley estimated that close to a quarter-million patients in the U.S. now receive stem cell treatments each year. Though many of these occur within FDA-approved clinical trials, their number is dwarfed nearly 10 times by the number of treatments that occur in private stem cell clinics. It shocked the audience of clinical trial suppliers to learn that there was no stem cell quality control test performed for any of these many treatments.

Even for approved stem cell medicine treatments like bone marrow transplantation and umbilical cord blood transplant, there is no stem cell-specific quality control test available. Counts of total cells are made, but these do not adequately predict stem cell number or function. Biomarkers designated for tissue stem cells are also expressed by stem cells' more abundant non-stem cell products. So, the biomarkers lack sufficient specificity to be used to count and monitor tissue stem cell function.

Without a quality control test for tissue stem cell number, stem cell treatments in all settings proceed without knowing the dose of treating tissue stem cells. This previously unavoidable therapeutic blind spot creates an instant treatment risk. It also precludes effective analyses to optimize treatment procedures, to compare different treatments, or to relate treatment outcomes to tissue stem cell dose. Without knowing stem cell dose, the interpretation of any stem cell treatment in terms of stem cells as the responsible agents is compromised.

In this context, Sherley announced briefly to attendees that Asymmetrex's new AlphaSTEM Test for counting adult tissue stem cells and providing data on their viability and tissue cell renewal function represented the needed first quality control test for tissue stem cell treatments, whether in clinical trials, in private stem cell clinics, or approved therapies. In particular, he indicated that both stem cell treatment patients and progress in stem cell medicine would benefit from existing clinical trial supply companies developing into future private stem cell clinic supply companies to insure the quality of stem cell treatment preparations. Sherley said that, of course, their partnership with Asymmetrex to implement its new stem cell-specific quality control test was an all around best solution for accelerating progress in stem cell transplantation medicine.

About Asymmetrex

Asymmetrex, LLC is a Massachusetts life sciences company with a focus on developing technologies to advance stem cell medicine. Asymmetrex's founder and director, James L. Sherley, M.D., Ph.D. is an internationally recognized expert on the unique properties of adult tissue stem cells. The company's patent portfolio contains biotechnologies that solve the two main technical problems production and quantification that have stood in the way of successful commercialization of human adult tissue stem cells for regenerative medicine and drug development. In addition, the portfolio includes novel technologies for isolating cancer stem cells and producing induced pluripotent stem cells for disease research purposes. Currently, Asymmetrex's focus is employing its technological advantages to develop and market facile methods for monitoring adult stem cell number and function in stem cell transplantation treatments and in pre-clinical assays for drug safety.

For the original version on PRWeb visit: http://www.prweb.com/releases/2017/03/prweb14146903.htm

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At 6th Annual Clinical Trial Supply New England 2017 Conference in Boston Asymmetrex Introduces A First Specific ... - Benzinga

Stem-Cell Clinic’s Treatments Left Three Patients Blind, Doctors Say – Wall Street Journal (subscription)

Stem-Cell Clinic's Treatments Left Three Patients Blind, Doctors Say
Wall Street Journal (subscription)
Three patients who underwent what they believed were stem-cell treatments for macular degeneration lost their vision as a result of the procedures at a Florida clinic, according to doctors who treated the patients afterward. The cases underscore the ...

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Stem-Cell Clinic's Treatments Left Three Patients Blind, Doctors Say - Wall Street Journal (subscription)