The article is a "call to awareness for patients, physicians and regulatory agencies of the risks of this kind of minimally regulated, patient-funded research," said Jeffrey Goldberg, MD, PhD, professor and chair of ophthalmology at the Stanford University School of Medicine and co-author of the paper.
Now, the patients are likely to remain blind, said co-author Thomas Albini, MD, an associate professor of clinical ophthalmology at the University of Miami, where two of the patients were subsequently treated for complications from the stem cell treatments.
The fat tissue was processed with enzymes, with the goal of obtaining stem cells.
The "trial" lacked nearly all of the components of a properly designed clinical trial, including a hypothesis based on laboratory experiments, assignment of a control group and treatment group, collection of data, masking of clinical and patient groups, and plans for follow-up, Goldberg and Albini said.
The authors acknowledged that it is difficult for patients to know whether a clinical trial, or a stem cell therapy, is legitimate.