In August 2015 Cytori Therapeutics announced that it has recently been informed that a company-supported trial in Japan has received approval to begin enrollment from Japan MHLW (Ministry of Health, Labor and Welfare).The ‘ADRESU’ trial is a 1-year open-label, multi-center, single arm trial to evaluate the efficacy and safety of periurethral injection of autologous adipose derived regenerative cells for the treatment of male stress urinary incontinence following prostatectomy for prostate cancer. The goal of the investigator-initiated trial will be to gain product approval for Cytori Cell Therapy technology for this indication.
The Biotechnician-What types of improvements are you hoping to see in this study in urine leakage volume?
John Harris-The primary endpoint for this trial will be the number of patients who experience reduction of urinary leakage volume of at least 50% after 52 weeks after treatment. We are hoping to see similar improvements to that observed in the pilot clinical trial for which results were published by Gotoh et al in the International Journal of Urology (http://onlinelibrary.wiley.com/doi/10.1111/iju.12266/epdf). In that study, the percent change between baseline and 12 months for daily leakage volume in 11 patients were decreased 40.9%.
The Biotechnician-What are some of the risks and uncertainties come with this trial?
John Harris-The risks that accompany this trial would be consistent with those of any clinical trial, with the most significant being that the results could differ from our expectations.
The Biotechnician-Why is Japan a target market for your firm?
John Harris-Japan is one of the largest healthcare markets in the world, and the Japanese government is significantly focused on regenerative medicine. Last year, they released two new laws covering regenerative medicine. Under these new laws, the cell types used in cell therapy and regenerative medicine are classified based on risk for practice of medicine and clinical study in order for physicians to use the cells clinically. Cytori Cell Therapy, which uses the patient’s own cells at the point-of-care, will be considered in the lowest risk category for most cases.
Cytori has been commercially active in the Japanese market since 2008 through our Japanese subsidiary and has had a fulltime office and in-country leadership in Japan since 2005. Over that period of time, Cytori has built a user base of approximately 50 sites including both hospitals and individual clinics.
The Biotechnician-If the Cytori Cell Therapy technology acquires approval in Japan, what are the next steps you will take in Japan? Do you see it being used often by physician's in Japan for who are dealing with Stress Urinary Incontinence?
John Harris-Following assessment of the results of the trial, Cytori and Nagoya University intend to file for medical device approval for the therapy, which in Japan is typically combined with reimbursement. Due to the lack of current effective therapies, once approved and reimbursed, we expect it to be considered as an effective treatment option for men with stress urinary incontinence. Incontinence after prostatic manipulation or surgery is notoriously hard to treat, and physicians currently have little to offer these patients beyond adult diapers and psychological support. This would greatly improve the patient’s quality of life.
The Biotechnician-What other countries in Asia are you seeking to gain product approval?
John Harris-We have recently obtained regulatory clearance in China for the Cytori Cell Therapy. That clearance marked our first access for the Cytori Cell Therapy to the mainland Chinese healthcare market.
The Biotechnician-Deregulation has thrust Japan to the forefront of a global battle for supremacy in regenerative medicine. How do you think this will make Japan into a center of regenmed?
John Harris-Some of the world’s most interesting regenerative medicine research is being done in Japan, such as the Nobel Prize winning iPS work being done in Kyoto. The new regenerative medicine laws were devised to continue to fuel that innovation. These two factors make Japan a very exciting market for regenerative medicine.
The Biotechnician-How has the loosening regulations in Japan's RegenMed space impacted your business?
John Harris-These new regulations made an already significant healthcare market even better. Cytori remains committed to this market and has continued to invest there.
The Biotechnician-What kind of challenges do you see in Japan's RegenMed space?
John Harris-The laws are still very new and their interpretation is still in a nascent stage.