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TOPIC: ANDRESU protocol published in Urology Journal

ANDRESU protocol published in Urology Journal 28 Sep 2017 06:26 #10095

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In scientific circles in Japan this gets quite a lot of attention- and since the study is not designed by Cytori, it is likely to be successful in view of similar studies already completed and reported upon.

The text-

Design of a single-arm clinical trial of regenerative therapy by periurethral injection of adipose-derived regenerative cells for male stress urinary incontinence in Japan: the ADRESU study protocol.

Shimizu S1, Yamamoto T2, Nakayama S3,4, Hirakawa A3,5, Kuwatsuka Y3, Funahashi Y2, Matsukawa Y2, Takanari K6, Toriyama K6,7, Kamei Y6, Narimoto K8, Yamanishi T9, Ishizuka O10, Mizuno M3, Gotoh M11.
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Abstract
BACKGROUND:
Male stress urinary incontinence is a prevalent condition after radical prostatectomy. While the standard recommendation for the management of urine leakage is pelvic floor muscle training, its efficacy is still unsatisfactory. Therefore, we have focused on regenerative therapy, which consists of administering a periurethral injection of autologous regenerative cells from adipose tissue, separated using the Celution® system. Based on an interim data analysis of our exploratory study, we confirmed the efficacy and acceptable safety profile of this treatment. Accordingly, we began discussions with Japanese regulatory authorities regarding the development of this therapy in Japan. The Ministry of Health, Labour and Welfare suggested that we implement a clinical trial of a new medical device based on the Pharmaceutical Affaires Act in Japan. Next, we discussed the design of this investigator-initiated clinical trial (the ADRESU study) aimed at evaluating the efficacy and safety of this therapy, in a consultation meeting with the Pharmaceuticals and Medical Device Agency.
METHODS:
The ADRESU study is an open-label, multi-center, single-arm study involving a total of 45 male stress urinary incontinence patients with mild-to-moderate urine leakage persisting more than 1 year after prostatectomy, in spite of behavioral and pharmacological therapies. The primary endpoint is the rate of patients at 52 weeks with improvement of urine leakage volume defined as a reduction from baseline greater than 50% by 24-h pad test. Our specific hypothesis is that the primary endpoint result will be higher than a pre-specified threshold of 10%.
DISCUSSION:
The ADRESU study is the first clinical trial of regenerative treatment for stress urinary incontinence by adipose-derived regenerative cells using the Celution® system based on the Japanese Pharmaceutical Affaires Act. We will evaluate the efficacy and safety in this trial to provide an adequate basis for marketing approval with the final objective of making this novel therapy widely available for Japanese patients.
TRIAL REGISTRATION:
This trial was registered at the University Hospital Medical information Network Clinical Trial Registry (UMIN-CTR Unique ID: UMIN000017901 ; Registered July 1, 2015) and at ClinicalTrials.gov (ClinicalTrials.gov Identifier: NCT02529865 ; Registered August 18, 2015).

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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

ANDRESU protocol published in Urology Journal 28 Sep 2017 06:32 #10096

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It is well-known that there was already a feasibility study on 11 patients which was published as a peer reviewed scientific paper- which I already shared- but for those who do not know- here it is again-

File Attachment:

File Name: 2014NagoyaUIResults.pdf
File Size: 2,265 KB


But that is not all- by coincidence I also found a Korean published study from 2016- also done with Celution and with promising results on male stress urinary incontinence patients after prostatectamy

File Attachment:

File Name: 2016-KoreanUIstudy.pdf
File Size: 869 KB
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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:
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