9 Things to Know About Stem Cell Treatments

✓Supports this

“A legitimate trial has to be approved by an independent research ethics committee and meet the requirements of the medicines regulator before it can start.”

Lists oversight by an independent medical ethics committee, and conformity to regulatory requirements including registration on a recognised trial registry, among the features that separate a responsible clinical trial from a treatment being sold. Stated as a general rule, not a national one.

✓Supports this

“Clinics selling unproven treatments tend to market straight to patients online and to lean on patient testimonials in place of evidence.”

Names this as the clearest way to tell a responsible trial from a clinic selling treatment. Specialists mostly see people by referral, while clinics selling stem cell treatments market directly to patients on the internet and on Facebook, and it explains why a testimonial can be sincere and still be misleading.

Clinics peddling unproven stem cell “treatments” frequently overstate the benefits of their offerings and use patient testimonials to support their claims.

7. Patient testimonials and other marketing provided by clinics may be misleading.

✓Supports this

“In a properly run clinical trial the participant is not charged for the treatment being tested or for the monitoring that goes with it.”

Lists this among the features that mark out a responsibly conducted clinical trial from an experimental treatment being sold, alongside ethics committee oversight and registration on a recognised trial registry.

The cost of the new treatment and monitoring is not covered by the participant.

8. An experimental treatment offered for sale is not the same as a clinical trial.

✓Supports this

“Stem cell treatments sold by private clinics are largely unapproved and unproven, the costs can be very large, and they carry real risks of harm.”

Covers all four parts. Beyond a short list of accepted uses, everything else is highly experimental; the society warns against treatments offered without regulatory approval or outside a registered trial; out of pocket costs can be enormous and are usually not covered; and complications can create new health problems or make the condition harder to manage.

All other applications of stem cells are yet to be proven in clinical trials and should be considered highly experimental.

1. Currently, very few stem cell treatments have been proven safe and effective.

✓Supports this

“One person's account of getting better after a treatment cannot show that the treatment was the reason.”

Explains why a sincere account can still be wrong. Someone may feel better straight after a treatment for reasons that have nothing to do with it, including belief that it will work, other things being done at the same time, lifestyle changes and the natural ups and downs of the condition, which is why a designed trial is needed to tell.

These testimonials can be intentionally or unintentionally misleading.

7. Patient testimonials and other marketing provided by clinics may be misleading

✓Supports this

“How a treatment reaches you, and who stands to make money from it, is one of the clearer ways to tell careful research from a sales pitch: clinics selling unproven treatments tend to market straight to patients.”

Says the way a treatment is marketed is one of the clearest differences between doctors running responsible trials and clinics selling something. Specialists mostly see people by referral, while clinics selling treatments advertise straight to patients and tend to overstate what they offer.

Most specialized doctors receive patient referrals, while clinics selling stem cell treatments tend to market directly to patients, often through persuasive language on the Internet, Facebook and in newspaper advertisements.

7. Patient testimonials and other marketing provided by clinics may be misleading

✓Supports this

“A laboratory finding or a small early study sits near the start of a long process, and is a long way from a treatment shown to work.”

Describes the route from science to medicine as lengthy and multi-step, with laboratory work, then animal work, then people, and says findings can fall down at any of those steps. It also says the current uses of stem cells are sometimes exaggerated by the media.

This process by which science becomes medicine is often long, but it is designed to minimize patient harm and to maximize the likelihood of effectiveness.

9. The process by which science becomes medicine is designed to minimize harm and maximize effectiveness

✓Supports this

“In a responsibly run trial the participant does not pay for the experimental treatment or the monitoring that goes with it.”

Lists the features of a responsibly run trial, which include independent ethics committee oversight, registration on a recognised trial registry, comparison against a control group, and no charge to the participant for the treatment or the monitoring.

The cost of the new treatment and monitoring is not covered by the participant.

8. An experimental treatment offered for sale is not the same as a clinical trial

✓Supports this

“Outside a short list of long-established uses, stem cell treatments are still experimental, and in the United States no stem cell product is approved for ALS/MND.”

Says the list of diseases stem cell treatments have been shown to help is still very short, covering blood and immune disorders treated by bone marrow transplant and some bone, skin and corneal grafts, and that everything else should be treated as highly experimental.

All other applications of stem cells are yet to be proven in clinical trials and should be considered highly experimental.

1. Currently, very few stem cell treatments have been proven safe and effective

✓Supports this

“Taking an unproven treatment can cause new health problems, cost a great deal, and make you ineligible for trials later.”

Sets out the same things that can be lost: complications creating new health problems or making symptoms harder to manage, becoming ineligible for future trials, and out-of-pocket costs that can be enormous and are usually not reimbursed. It is written about stem cell clinics, though the trial-eligibility point is stated for any unproven or experimental treatment.

Receipt of one unproven or experimental treatment may make you ineligible for future clinical trials or treatment options.

2. There is something to lose when you try an unproven stem cell "treatment"

✓Supports this

“Many ideas that look promising early on do not survive later testing, and that is a normal part of how treatments are developed.”

Describes the same pattern on the route from laboratory work to medicine. Something that looked promising in the laboratory may fail in animals, something that worked in animals may fail in people, and something that helps symptoms may still carry risks that rule it out.

During this process, scientists may discover that an approach that seemed promising in the lab, does not work in animals, or that an approach that worked in animals, does not work in humans.

9. The process by which science becomes medicine is designed to minimize harm and maximize effectiveness

iAdds context

“Unproven treatments sold to people with a serious condition are not all harmless. Complications can create new health problems or make symptoms harder to manage, and the costs can be very large.”

Sets out what can be lost by trying an unproven treatment: complications that create new health problems or make symptoms harder to manage, becoming ineligible for future trials, and out-of-pocket costs that can be enormous. It is written about unproven stem cell treatments rather than unproven ALS/MND treatments in general, and it never mentions ALS/MND.

Complications may create new short- and long-term health problems, and/or may make your condition or symptoms more difficult to manage.

2. There is something to lose when you try an unproven stem cell "treatment"