Some stem cell clinics pose threat to patients seeking AMD treatment

Patients and physicians should be aware of warning signs for potentially dangerous clinics.

Patients interested in stem cell therapy for ophthalmic issues should take precautions to find clinics that are licensed, are associated with an academic center, have a history of running clinical trials and do not require patients to pay out of pocket.

Three patients with bilateral vision loss after bilateral intravitreal injection of stem cells for age-related macular degeneration at the same stem cell clinic reported to Bascom Palmer Eye Institute and Dean McGee Eye Institute with serious complications after their procedures, Ajay E. Kuriyan, MD, MS, told Ocular Surgery News.

“All of the patients underwent intravitreal injections of 0.1 cc of autologous adipose tissue-derived stem cells. They paid $5,000 for the procedure and signed a consent form for the procedure, but it was not a study consent form. They were all referred to the clinicaltrials.gov site, almost as an advertisement about this injection site,” Kuriyan said in a presentation at the American Society of Retina Specialists annual meeting in San Francisco.

Legally blind

The clinic did not have a licensed ophthalmologist on site, and the stem cell injections were administered by a nurse practitioner. The first patient was a 72-year-old woman with a history of dry AMD and a visual acuity of 20/60 in the right eye and 20/40 in the left eye before the procedure. She presented to Bascom Palmer 3 days after the procedure with decreased vision, pain, vomiting and nausea, Kuriyan said.

Upon examination, the patient had an IOP of 66 mm Hg in the right eye and 59 mm Hg in the left eye. She underwent a bilateral pars plana vitrectomy and pars plana lensectomy on the same day. Her IOP improved, but her visual acuity progressed to no light perception in both eyes after a few weeks, according to Kuriyan.

A year after the procedure, the 72-year-old woman and two other patients who received treatment at the clinic are now legally blind and will likely not get better, Kuriyan said.

Potential causes may be contamination of the material injected into the eye with toxic substances or the use of trypsin or collagenase during stem cell isolation. It is also possible there may be growth factors and cytokines in the material injected into the eye driving undifferentiated stem cells to myofibroblasts, resulting in traction on the surface of the retina, he said.

Warning signs

Kuriyan said patients and physicians should be aware of several warning signs for potentially dangerous clinics offering these treatments, including whether the facility is a standalone clinic that is not affiliated with an academic institution or the facility does not have a history of conducting clinical trials.

“That is a big warning sign for these stem cell studies. The other big warning sign is when patients are asked to pay,” Kuriyan said. In some trials, patients are legitimately asked to pay for a portion of the care; if that portion is considered a standard of care, then insurance generally pays for that part.

“It is the out-of-pocket expense that is a warning sign for patients,” he said.

Potential benefits

These few cases should not dissuade patients or physicians about the potential benefits of stem cell procedures.

“Stem cell treatments for ophthalmic disorders have great potential, and we don’t think these outcomes should dampen our enthusiasm for stem cell research. However, the isolation and delivery methods for these stem cells need to be carefully scrutinized to minimize patient risk. Both patients and physicians need to be aware of these potentially devastating outcomes, and we need to help educate our patients that even if a study is approved by the IRB or is on clinicaltrials.gov, it does not mean it is a good idea to get this procedure performed,” Kuriyan said. – by Robert Linnehan

Disclosure: Kuriyan reports no relevant financial disclosures.

Patients interested in stem cell therapy for ophthalmic issues should take precautions to find clinics that are licensed, are associated with an academic center, have a history of running clinical trials and do not require patients to pay out of pocket.

Three patients with bilateral vision loss after bilateral intravitreal injection of stem cells for age-related macular degeneration at the same stem cell clinic reported to Bascom Palmer Eye Institute and Dean McGee Eye Institute with serious complications after their procedures, Ajay E. Kuriyan, MD, MS, told Ocular Surgery News.

“All of the patients underwent intravitreal injections of 0.1 cc of autologous adipose tissue-derived stem cells. They paid $5,000 for the procedure and signed a consent form for the procedure, but it was not a study consent form. They were all referred to the clinicaltrials.gov site, almost as an advertisement about this injection site,” Kuriyan said in a presentation at the American Society of Retina Specialists annual meeting in San Francisco.

Legally blind

The clinic did not have a licensed ophthalmologist on site, and the stem cell injections were administered by a nurse practitioner. The first patient was a 72-year-old woman with a history of dry AMD and a visual acuity of 20/60 in the right eye and 20/40 in the left eye before the procedure. She presented to Bascom Palmer 3 days after the procedure with decreased vision, pain, vomiting and nausea, Kuriyan said.

Upon examination, the patient had an IOP of 66 mm Hg in the right eye and 59 mm Hg in the left eye. She underwent a bilateral pars plana vitrectomy and pars plana lensectomy on the same day. Her IOP improved, but her visual acuity progressed to no light perception in both eyes after a few weeks, according to Kuriyan.

A year after the procedure, the 72-year-old woman and two other patients who received treatment at the clinic are now legally blind and will likely not get better, Kuriyan said.

Potential causes may be contamination of the material injected into the eye with toxic substances or the use of trypsin or collagenase during stem cell isolation. It is also possible there may be growth factors and cytokines in the material injected into the eye driving undifferentiated stem cells to myofibroblasts, resulting in traction on the surface of the retina, he said.

Warning signs

Kuriyan said patients and physicians should be aware of several warning signs for potentially dangerous clinics offering these treatments, including whether the facility is a standalone clinic that is not affiliated with an academic institution or the facility does not have a history of conducting clinical trials.

“That is a big warning sign for these stem cell studies. The other big warning sign is when patients are asked to pay,” Kuriyan said. In some trials, patients are legitimately asked to pay for a portion of the care; if that portion is considered a standard of care, then insurance generally pays for that part.

“It is the out-of-pocket expense that is a warning sign for patients,” he said.

Potential benefits

These few cases should not dissuade patients or physicians about the potential benefits of stem cell procedures.

“Stem cell treatments for ophthalmic disorders have great potential, and we don’t think these outcomes should dampen our enthusiasm for stem cell research. However, the isolation and delivery methods for these stem cells need to be carefully scrutinized to minimize patient risk. Both patients and physicians need to be aware of these potentially devastating outcomes, and we need to help educate our patients that even if a study is approved by the IRB or is on clinicaltrials.gov, it does not mean it is a good idea to get this procedure performed,” Kuriyan said. – by Robert Linnehan

Disclosure: Kuriyan reports no relevant financial disclosures.