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For those requiring transplants or amputations, obtaining biological replacements has become as simple as visiting a local stem cell clinic. These businesses offer the convenience and speed of a pharmacy with the prices much lower than a traditional health care facility, and this has spawned rapid growth throughout the biomedical industry. But with the falling costs and rising popularity comes a dangerous side effect; one some people have described as a nightmare.

Three months ago, Mariah Keen, 34, lost sight in her left eye following a snowmobiling accident. The damaged tissue was surgically removed and a cluster of stem cells—taken from her own bone marrow—was implanted at the terminal end of the optic nerve. Except for the initial stem cell extraction, the entire procedure took only an hour

But after five weeks, the eye failed to take shape. Instead, the socket had filled with a tumor-like mass. When Keen returned to the clinic, Pine View Biotechnologies in Missoula, AR, they confirmed her worst fears: the stem cells had formed into the wrong organ. Instead of an eye, Mariah Keen was growing a third lung.
“The clinic confirmed her worst fears: the stem cells had formed into the wrong organ.”
“It was pretty much the worst case scenario. They said it was going to be a straightforward operation, but now I’ve got this,” she said, referring the shroud she now wears on the left side of her head. Due to the proto-bronchial tube fusing to the optical nerve, Keen said the doctors were hesitant to remove the offending material, citing possible damage to the nerve which could lead to permanent blindness. The cover prevents outside contact with the lung tissue, now protruding from the socket, which could lead to severe hemorrhaging if punctured.

A spokesperson for Pine View declined to comment, saying they could not discuss treatments currently underway.

Stem cell expert and patient’s rights activist Dr. Abraham Phillips said the situation has become more common as the treatments begin to be administered by less experienced personnel.

“In some cases, the slurry used to coax stem cells into one organ vice another can differ by a single type of molecule,” Phillips said. “Even contamination from outside air can set off a series reactions which could cause the cells to fail to develop the proper morphology, even if the correct type of tissue is present.”

While Mariah Keen’s case is extreme, she can be considered fortunate in some respects, as her condition may be corrected with a minimum of invasive surgery. Others are not so lucky.

Paul Coronado, 25, was born with proximal femoral focal deficiency, a birth defect causing his right femur to be shorter than his fully grown left. In the past, corrective action would consist of a cumbersome heel lift, or painful operations to lengthen the bone. Today, the shorter leg is lengthened with an infusion of bone stem cells—a simple and relatively painless procedure with the highest success rate of all available stem cell treatments.

But even the safest procedures have a degree of risk.

“At first everything was fine,” says Coronado. “They did all the medical stuff, and I was pretty excited when my leg started to grow. But then it kept growing, and [the doctors] didn’t know what was wrong. They couldn’t get it to stop.”

Coronado’s right leg is now a full thirteen inches longer than his left—a much greater span than the two and a half inch difference prior to treatment. Coronado sued the Zia-Feng Group, whose office in Tampa, FL performed the procedure. During the proceedings it was revealed that the cells donated by Coronado’s brother were inadvertently switched with those from another patient, Ryan Myers. Myers stands 6′7″ to Coronado’s 5′2″, accounting for the difference in leg length. The mistake was due to the two men sharing a social security number which varies by only a single digit.

Doctor Shen Xi, an employee of the Zia-Feng Group who assisted with Coronado’s treatment, said, “Mistakes were made. Zia-Feng puts forth every effort to ensure the integrity of its programs, and all errors are regretted.” He would not comment on the actions needed to correct the error. Again, we spoke with Dr. Phillips.

“In Paul’s case, since the leg is, technically, completely healthy, it introduces a number of complications. Do we destroy healthy tissue and try again? If the leg is amputated and regrown fully, that could take the better part of a decade, and it is extremely risky. The current femur could be reshaped, but this involves an operation which the original stem cell treatment was designed to eliminate in the first place. Unfortunately, he does not have many options.”

Another with few options is Salvador Montalva, 52, living in Santiago, Chili. He was diagnosed with Zollinger-Ellison syndrome after complaining of persistent stomach ulcers. The associated pancreatic tumor was benign, but the decision was made to grow Montalva a replacement pancreases and remove the diseased organ.

According to Dr. Eduardo Aylwin of the Sigma Institute, the procedure was performed correctly through all steps. Like many stem cell operations, the cells were harvested from Montalva’s own bone marrow. It has previously been thought that these cells could only differentiate into certain structures, lacking the ability to grow into more than a single type of organ at one time. Salvador Montalva proved to be the exception to this hypothesis.

“As soon as the structure was large enough to be studied with any certainty, we could immediately tell that it was not forming properly,” explains Dr. Aylwin. “We informed the patient right away, and he agreed to closer monitoring. After a few weeks, he began complaining of a pain in his side. After a series of tests and x-rays, we finally discovered the problem. Mr. Montalva’s stem cell infusion had developed into a fetus.”

Other experts are hesitant to call the growth a fetus, likening it to a highly ordered tumor, or in some cases, a parasite. However, the resemblance is unmistakable. Doctor Aylwin elaborated, “it has a heart and clearly differentiates into a head and torso, and limbs.” It is, of course, only a copy of Montalva’s own self—containing only his DNA—and it is not clear that the fetus would ever be able to survive outside Montalva’s body.

“It does not have an umbilical cord, but seems to receive nutrients from a network of blood vessels connecting through its left side,” said Dr. Aylwin. “It is unlikely that this could be separated from its host and maintain viability.”

Despite this medical prognosis, Montalva has been unable to have the growth removed. Chili has a strict anti-abortion policy, prohibiting the procedure for any reason. Seeking approval through Chili’s medical ethics committee, the physicians at the Sigma Institute were dismayed to hear the ruling: any attempt to remove the growth—the fetus, as it was referred to in their report—would be considered illegal, and prosecuted as such. Montalva’s attempts to lobby for an exception to be made in his case have proven unsuccessful.

The chair of the Organization for Unborn Rights, Andrea Ruiz, said, “we can’t be sure if this is a fetus or not. If it is—as it certainly appears to be—than killing it would be criminal. Why should this unborn child be punished as a result of the human race playing God?”

Montalva has been in contact with a number of supporting groups internationally, in an attempt to get him the needed medical procedure in a country where abortion is legal. However, he has been threatened with legal action upon his return.

“There is always an exception, always,” Montalva said. “I just never thought it would be me. Even so, I find it incredible that people cannot understand that this is clearly different from the norm.” When asked about his personal views regarding abortion before or after the event, he declined to comment.

In all these instances—and many more like them—the issue of who pays is always one of the first breeched, and one of the last settled. In some cases, such as Salvador Montalva’s, the relationship between doctor and patient remains amicable, even when the clinic is contractually abrogated from paying. However, this is often not the case, as some clinics, particularly those in the United States, are permitted to operate without the standard gamut of malpractice insurance required by a full fledged medical institution.
“That a clinic performing such a delicate medical act can get away with such gross negligence is, frankly, shameful.”
A number of bills have been introduced in congress, but none have yet passed. The struggle over the clinic’s right to operate under current case law often conflicts with a patient’s perceived right, and the fact that such patients often do not legal have rights, except in arbitration, complicates the matter further. A number of lawsuits have been brought against no fewer than eighteen different clinics in the United States. All but one—Paul Coronado’s—were thrown out due to arbitration clauses in the patient’s contract.

Doctor Philips is on record as saying, “That a clinic performing such a delicate medical act can get away with such gross negligence is, frankly, shameful. A patient’s bill of rights cannot come soon enough.” Even so, previous bills have been deadlocked and even filibustered in congress, and it does not look likely that any progress will be made until after the next election.

In the meantime, Doctor Phillips continues to fight for those who’ve been physically and emotionally scarred by stem cell malpractice. He has maintained that the amount of mental hardship that comes from having one’s body deformed by a botched medical procedure is something of which we’re only just beginning to see the ramifications.

“Certainly there were horror stories from years past about patients having the wrong leg amputated, or the wrong lung removed, or what have you. But we’re only now finding out the full trauma induced by having parts grow where they shouldn’t. It’s unsettling like nothing we’ve ever experienced before.”