Non-obstructive azoospermia is medically unmanageable, so no treatment options are available

Recently, Kallistem, a French biotech company working in the area of male infertility became the first in the world to develop a technology to produce fully-formed human spermatozoa in-vitro. In an email interview, Isabelle Cuoc, CEO of Kallistem tells M Neelam Kachhap about the ground-breaking technology and her plans for taking the technology to market

Recently, Kallistem, a French biotech company working in the area of male infertility became the first in the world to develop a technology to produce fully-formed human spermatozoa in-vitro.  In an email interview, Isabelle Cuoc, CEO of Kallistem tells M Neelam Kachhap about the ground-breaking technology and her plans for taking the technology to market

What is the prevalence of male infertility today?

201507ehm37The average estimate through occidental region is an average of 15 to 17 per cent of couples suffering from infertility with a prevalence of 30 per cent ; within those 15-17 per cent for men, 30 per cent for women and 33 per cent for an indetermined reason (both sexes probably together). For non-obstructive azoospermia, our estimations as of today is a prevalence of 120 000 adults in the world as a minimum. Non-obstructive azoospermia, is medically unmanageable, so no treatment options are available.

What are the available treatment options?

Methods of managing infertility depends of the type of infertility. For example, hormonal dysfunctions are treated with hormonal treatment or an obstructive azoospermia can be managed by surgery. Similarly in some non-obstructive azoospermia cases a biopsy is performed to look for one spermatozoa to perform intracytoplasmic sperm injection (ICSI) the average success rate for this is about 50 per cent. However, for non-obstructive azoospermia without testicular spermatozoa, which appears in 50 per cent of the cases today, there is no treatment. These patients have to look for a sperm donor. The technology developed by Kallistem addresses ‘non obstructive azoospermia’ only if the patient has primitive germ cells in the testes.

Tell us  about your innovation for the treatment of male infertility?

Today, if a patient does not produce mature spermatozoa but has only immature germ cells in his testes for any reason (mainly related to sertoli cells which are the nurses of germ cells), it is not possible to use those cells for ICSI because genetic and epigenetic transformations have not been completely achieved. The solution of Kallistem is to use the biopsy to perform a culture of up to 72 days to allow the full maturation of the spermatozoa in vitro with the same physiological conditions as possible than the one in the body. The innovation lies in the bioreactor which has been designed to perform this culture plus the know how to cultivate the male germ cells.

What is the significance of the ability to make viable sperms in vitro?

The significance is that earlier it was not possible but now we can have viable sperms. However, these sperms can be used for ICSI and not IVF (cannot work as it needs motile spermatozoa) to get babies. But it needs to be accepted by regulatory agencies and governments to make sure that everything is safe for the patient.

Could you talk about the clinical trials for your product/ technology?

Yes, clinical trails are in plans. We plan to do it in 2017. We do not have a precise study plan right now. We are in a process of looking for investors to help us in our endeavour.

Can you share the product development timeline for this technology?

If we succeed with fund raising, we could start clinical studies in 2017 as I told you, and commercialisation from 2020.

Would you tie-up with infertility clinics to bring the technology closer to people?

Yes we would. This is definitely the plan. We are doing our best to get the best development for the patient in term of safety, accessibility and availability as soon as possible.

You have given hope to millions of couples worldwide, India is eagerly awaiting for your technology. How and when can patients in India avail of this medical breakthrough?

Today, it is more an issue of fund raising for us. The scientific team has been working since 20 years on it and is impatient to go through the regulatory process. We still have some development to do but it is development, not research. It’s only a matter of time. So, we cross our fingers.

mneelam.kachhap@expressindia.com

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