Last week, Cytori Therapeutics made news when they announced they had suddenly halted their ATHENA and ATHENA II clinical trials. The company announced the news in a press release, following what it described as “safety review of reported cerebrovascular events.” The company reported that certain patients had observed complications with blood flow to the brain following administration of the therapy. The company claimed:
“Symptoms occurred in three patients, of which two patients’ symptoms fully resolved within a short period of time and the third patient has had substantial resolution of symptoms.”
While it is promising that two of the three patients recovered quickly, the concern is significant enough to put a dent in the proceedings (Cytori’s shares fell by more than 13% following the announcement).
The trials aim to investigate the safety and feasibility of adipose-derived stem cells for the treatment of chronic myocardial ischemia. Speaking to Forbes, Timothy Henry, the co-principal investigator of the trials, claimed that the complications were from the “use of electroanatomical mapping,” which facilitates the intervention and expressed hope for the studies to resume once issues are resolved.
Elsewhere, Bioheart announced that it had successfully completed a combination stem cell treatment using AdipoCell and MyoCell on a patient with congestive heart failure. AdipoCell are Bioheart’s proprietary adipose-derived stem cells, and the news comes on the heels of the successful clinical results on AdipoCell the company reported earlier this year.
These are two examples of the more high-profile trials approved by the FDA that have recently made headlines.
Clearly, isolating stem cells from fat is a growing industry that is expanding in multiple areas: the market for medical devices devoted to the isolation of stem cells from adipose tissue is serious business, with over a dozen companies developing products to enable more efficient isolation of such cells.
On the therapy side, the tide may be turning: Just like the two examples mentioned above indicate, treatments involving the use of adipose-derived stem cells are also growing – however, many of them are still controversial. There have been reported to be over 100 clinics currently administering stem cell treatments around the USA. Many of them, under the umbrella of the Cell Surgical Network, have attracted a lot of interest recently when their practices were brought into question. The specifics were discussed at length elsewhere, but the Network made news recently when Nature Medicine reported on the scientific community’s efforts to pressure the FDA’s Center for Biologics Evaluation and Research to investigate whether the CSN was violating federal regulations governing the administration of stem cell–based products.
Whatever the legalities end up being, we are at an intriguing point for the field of adipose-derived stem cells: both legally as well as from a scientific perspective, the tide is moving forward rapidly.
For more on these cells, we devoted a blog entry on the isolation of stem cells from adipose tissue, wherein we also introduced Matrixyme, Akron’s entry into the adipose tissue derived-stem cell arena. More to follow…