OvaScience’s mitochondrial egg booster product may face FDA delay.

September 11, 2013Carole 2 Comments »

Some of you may have been following my posts on rejuvenating older eggs:

Can ovarian stem cell technology replenish ovarian reserve?

Rejuvenating gonads with stem cells

In these posts, I mention the product Augment, which is being developed by the company OvaScience, as a means to boost egg quality in older women.  The idea behind Augment is that by injecting eggs with extra mitochondria  (previously derived from the patient’s own egg stem cells) the eggs will have more mitochondria to work with and become energized.

This concept is based on pioneering studies by Jon Tilly, PhD that suggested that in some mammals (mice, and  probably women) the ovary may not actually contain all the eggs it will ever have. Instead, like men, who continually produce sperm from sperm stem cells, women may have a tiny number of these gemete-producing stem cells too. We aren’t really sure what female stem cells are doing there in the ovary- at best, they are weakly active. However, Tilly’s data in mice (and apparently now also in studies using stem cells from women) suggest that it  is possible to selectively pluck the stem cells out of the ovary, grow more of them in the lab, then harvest the mitochondria from stem cells for injection into the older woman’s eggs after retrieval in an IVF cycle- at the same time as sperm injection (ICSI).

Mitochondria are the powerhouses of the cell, the source of energy for cells to do their work. The idea is that older eggs may be energetically exhausted and a boost of extra mitochondria (delivered at the time of ICSI in an IVF cycle) may just give them the boost necessary to become fertilized and make a healthy implantation-ready embryo. This depleted- mitochondria theory is also used to explain why older women get pregnant so easily with donor eggs from much younger women. OvaScience is working to translate this basic research into a clinical application ( the mitochondrial product derived from ovarian stem cells is called Augment) to be used with patients.

From time to time, I have had patients inquire about participating in the US clinical studies on Augment. It was unclear whether OvaScience was already actively enrolling patients. Now it looks like US patients may have to wait a while longer if they are interested in enrolling in a clinical trial to test Augment.  US clinical trials on Augment , have been put on hold while OvaScience addresses FDA concerns that Augment should be classified as a drug rather than a  human cell and tissue product (HCT/P). It appears that OvaScience will increase their efforts to enroll patients in clinical  study sites outside of the US as they sort out these concerns.

The FDA moves in mysterious ways –it’s hard to see how a product consisting of cell organelles (mitochondria) is more like a drug,  than it is like a cell and tissue product. Here’s an article that describes the FDA concerns and OvsSciences response to it. But depending on how the FDA classifies Augment, the road to market may be much longer than the optimistic 2014 originally predicted. Getting a drug to market is a much more regulated and lengthy process than what currently applies to the use of HCT/Ps in IVF. You can read the press release from OvaScience here.

I have been hoping for huge leaps forward in the IVF field. Some advances are real game changers for patients. ICSI was one. Extended culture was one. Embryo biopsy and PGD testing is another. I think something like Augment- if it can safely deliver on its promises- could be one of those game changers for older patients. Stay tuned.

(Disclaimer: I have no financial relationship with OvaScience.)

© 2013, Carole. All rights reserved.

2 Responses to this entry

Join the discussion