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Claims that torn meniscus can be regenerated based on single case study wither under scrutiny

Stem Cells Shows Promise For Repairing Torn Meniscus

Our Review Summary

This news release describes the results of an experiment using stem cells and other blood components derived from fat tissue to repair a torn meniscus. The release relies on general statements regarding the degree of benefits or harms to the patient and ignores the issue of costs entirely.  It doesn’t adequately explain the research. It suggests that the approach described is readily available, although it is not.

Both the release and the published report are based on a single patient case, not a clinical trial (or even a case series).  As such, the data supporting the release are very limited.

 

Why This Matters

Injuries to the meniscus are common among Americans and the routine approach to fixing them involves surgery.  If a new method could avoid an invasive approach, that would be a boon to public health. But this new approach requires sophisticated cellular separation techniques which are not cheap.  And touting the results of one experiment on a single patient followed for barely a year is clearly premature.

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

There is no mention of the cost of this proposed procedure to the patient, nor is there any indication that such a procedure might be covered by medical insurance, since this is a very early experimental approach. The procedure involves outpatient liposuction to obtain a small quantity of the patient’s fat tissue, and various complicated separation procedures to obtain the cell mixture ultimately used in the treatment. The cost for each of those procedures should be well-known and the release could have offered a comparison with the typical cost of the current approach to treating meniscus injuries.

Does the news release adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

The news release doesn’t give any data on how large/small are the potential benefits. It only offers general statements such as, “the patient reported a reduction in pain and an improvement in knee function.” The release notes that two images were taken, the latter which shows the absence of a tear while the former shows the tear present. The release also offers, “The arthroscopic images showing resolution were also consistent with quality of life improvements for the patient, including a reduction in pain and resumption of normal activities. The patient experienced very little downtime and was able to resume normal activities in less than 1 week.”  As noted above, this report is of a single patient case — there was no clinical trial involved.

Does the news release adequately explain/quantify the harms of the intervention?

Not Satisfactory

While the release’s statements (mentioned above) refer to positive outcomes and mention no adverse effects, readers can’t draw any conclusions about the safety of the procedure, given it’s a single case study and a short-term follow-up.

Does the news release seem to grasp the quality of the evidence?

Not Satisfactory

The news release is based on a single patient’s experience – pretty low on the quality of evidence scale.  At best, it might be an indicator that a new approach might be useful, but no conclusions about importance should be drawn by readers based on a single patient’s experience.

Does the news release commit disease-mongering?

Satisfactory

No disease mongering apparent here. The release provides some context regarding the incidence of torn meniscus.

Does the news release identify funding sources & disclose conflicts of interest?

Not Applicable

While it isn’t explicitly stated, readers probably assume that this research was funded by US Stem Cell, Inc. The lead investigator is identified as the company’s chief science officer, so her potential conflict is clear.  There is no additional information offered on the remaining two investigators.

Does the news release compare the new approach with existing alternatives?

Satisfactory

The release adequately covers this category by offering the following statement:  “Approximately 850,000 patients each year are surgically treated — often arthroscopically — for meniscal injuries.”

Does the news release establish the availability of the treatment/test/product/procedure?

Not Satisfactory

The release never emphasizes the early stage nature of this work.  Knowledgeable readers might know that news of a single case study may be just the beginning of a long-term research effort, but nothing in the release expresses that to readers who may be less knowledgeable.

Does the news release establish the true novelty of the approach?

Not Satisfactory

Certainly, a non-surgical method of repairing injuries to the meniscus — if it were readily available to patients — would warrant news coverage.  In this case, however, this release is woefully premature.

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Not Satisfactory

The quote from the lead investigator suggests the procedure is more advanced than it is:  “Use of one’s own healing cells to help repair damaged tissue rather than having to cut open or manipulate the damaged area to try to reduce pain and restore function is the most elegant form of regenerative medicine we have today (emphasis added).”  According to the NIH, “Animal and small pilot human studies are currently paving the way for large scale clinical trials to treat many intractable diseases.”

Total Score: 2 of 9 Satisfactory

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