Recently the question was raised whether anybody ever had encountered a negative scientific -peer reviewed- study involving Cytori´s processing device Celution, which had been-as written- unfavorable i.e. negative in its conclusions.
In order to be able to give a substantiated answer to this question, one really has to know first which scientific- peer reviewed- papers do exist on the subject, so since I have been rather involved with the art of interrogating databases, I did so with the pretty substantial- and complete PubMed database. Off late the DB has been returning more and more publications from Private Investigator clinics and it is very likely that the funnel of these investigations has been growing and growing and beats the quality of Cytori´s past own investigations by many many miles. But also, that funnel will also "spit out" more results in the near future- Cugat -as an example- is expected any day now with his ACL results.
So- it starts to be interesting to put FOCUS on what is being issued in the various scientific journals of the globe, in order to be able to glimps at Cytori´s platform future.
In order to do so- glimpsing on what is ongoing- I did a query on the PubMed database with the search parameter " Celution" at present- end July 2016- 19 positives are returned, which you will find listed below. Going forward the list will stop at 20....but will start with the latest published article and will delete the eldest.
To answer that question- yes, there is one. A study from Finland I believe, where the investigators used "water assisted liposuction" for their scientific comparison with manual extraction of supercharged fat in reconstruction. All I recall is, that I inquired in Finland, why the hell they did this study with this lipo device. The PI answered me that he did the study, since he was a friend of Adam Katz- Co-founder of StemSource. For insiders, this is all explanatory...
The Query Results
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.
BMC Urol. 2017 Sep 25;17(1):89
Authors: Shimizu S, Yamamoto T, Nakayama S, Hirakawa A, Kuwatsuka Y, Funahashi Y, Matsukawa Y, Takanari K, Toriyama K, Kamei Y, Narimoto K, Yamanishi T, Ishizuka O, Mizuno M, Gotoh M
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).
PMID: 28946874 [PubMed - in process]