News that revolutionary "bionic vaginas" created from pig intestines and human cells could soon be developed has been revealed this week.
The vaginas would help thousands of women who currently suffer from the Mayer–Rokitansky–Küster-Hauser syndrome (MRKH), where the vagina does not completely develop and other conditions where the vagina is closed or nonexistent.
The research is still in its early stages and needs more funding to continue but is presented as a breakthrough by some and as bogus snake oil by others. The vaginas are actual not "bionic" (bionic usually means the donated body parts are electromechanical) but bioengineered (from artificial tissues).
It also appears that the man behind the whole operation, Dr Alexander Seifalian, is a controversial figure within the scientific community. Seifalian is Director and Professor of Nanotechnology & Regenerative Medicine at NanoRegMed.
In 2016, he was dismissed from his position at University College London as a Professor of Nanotechnology & Regenerative Medicine after he was found guilty of dishonestly taking $24,000 from an overseas student.
Two UCL research misconduct investigations are still ongoing against Seifalian regarding his time as a professor.
In September 2017, UCL published the results of an independent inquiry it conducted on its regenerative medicine staff's relationship to disgraced Italian surgeon Professor Paolo Macchiarini and the Karolinska Institute.
Macchiarini was heavily criticised for implanting artificial tracheae and performing other operations on live patients at the Karolinska University Hospital, were he worked as a surgeon. Six of the eight patients who received artificial tracheae died some time after their operations.
The report was deeply critical of Seifalian. The plastic scaffolds Macchiarini used in his transplants had been supplied by Seifalian and manufactured by a number of UCL's scientists. They included an artificial windpipe, an arterial graft and a synthetic tear duct. However, It was revealed that these grafts had not been cleared to be used on humans and were still at the experimental level.
Professor of transplantation surgery at the University of Edinburgh, Stephen Wigmore, who chaired the UCL inquiry said the results were "quite frightening" and that the patients had been used as "guinea pigs."
Seifalian's lab was not licensed to produce clinical grade devices, and no one asked for special permission to use the experimental grafts on humans. Although Seifalian and the other UCL scientists were not held responsible for the failures of the grafts, they shouldn't have distributed them in the first place.
"It's very serious and it's quite frightening to think that someone could be manufacturing this kind of device without knowing the regulations that govern it," Wigmore said.
Upon publishing the inquiry's results, UCL said in a statement that it deeply regretted "that materials (known as POSS-PCU constructs), that had not undergone rigorous pre-clinical assessment and which were not made to GMP standards, were manufactured and supplied by Professor Alexander Seifalian's research laboratory for direct clinical use."
Seifalian feels he was unfairly singled out in the UCL report: "Many people were involved in the regenerative medicine work with me but I have been dismissed and [they are] using me as a scapegoat for the work carried out," he told the Guardian at the time of the report's publication.