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Peer Reviewed Publications 18 Nov 2017 13:51 #10587

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Surely it must have come as some surprise to "old-timers", that Cytori i.e. Hedrick suddenly changed course in his disclosure strategy from where he started 3,5 years ago- that was at the beginning of his tenure, sole focus on corporate i.e Cytori controlled clinical trials and only add to those when financing of "new" applications on the corporate level was assured.

We can conclude now that he f*cked up on the two major clinics OA-ACT and STAR,which he initiated in his reign, although all is not lost as most of us agree upon. But, what John and I have always demanded (in vain) he is suddenly executing - putting focus on the IIS developments, which to me are as good as any, to land a partner for further development.

Last weeks announcement on the ONGOING investigator trials sparked a lot of hope with me, since simply there are quite a few clinics ongoing which could be the start of something beautiful, see my post HERE , however most likely will not relieve us of the biggest pain - cash requirements to run the business in the short to immediate term.

A slide that I have shown many times, was taken from presentations in the pre-Hedrick, i.e. Calhoun days- mainly in 2013 - which you see below. (there were other too showing more) Of course a lot of those have been completed, but also quite a few have been reported upon by investigators and as we now know- as of late 2017 - there are about 21 left in process.



A disclosure change of heart (i.e. strategy) for the better in my view.
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Peer Reviewed Publications 18 Nov 2017 13:57 #10588

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From those completed trials and IIS studies a gigantic pile of peer reviewed papers are left as "inheritance". Will they ever have a chance to be further developed? I sincerely hope so, but that obviously depends.....

Here is the list which you can find at : http://www.cytori.com/our-technology/ It is pretty gigantic and you better go there, since all entries have links, which you can click. I copied it only to here to give an impression.....:grin:

Cytori’s technologies and investigational products have been evaluated in both pre-clinical and clinical research studies and cited in peer-reviewed publications.
Akita S et al. “Autologous adipose-derived regenerative cells are effective for chronic intractable radiation injuries.” Radiation Protection Dosimetry, 151:4; 656-660; 2012.
Akita S et al. “Noncultured Autologous Adipose-Derived Stem Cells Therapy for Chronic Radiation Injury.” Stem Cells International, 2010.
Andjelkov K et al. “A novel method for treatment of chronic anal fissure: adipose-derived regenerative cells – a pilot study.” Colorectal Disease, 19:6; 570-575; 2017.
Andjelkov K et al. “Posterior Fourchette Fissure Resolution After Injection of Autologous Adipose-Derived Regenerative Cells.” Obstetrics & Gynecology, 129:3; 497-499; 2017.
Aronowitz J et al. “Adipose Stromal Vascular Fraction Isolation: a Head-to-Head Comparison of Four Commercial Cell Separation Systems.” Plastic and Reconstructive Surgery, 132:6; 932e–939e; 2013.
Boissier R et al. “Histological and Urodynamic Effects of Autologous Stromal Vascular Fraction Extracted from Fat Tissue with Minimal Ex Vivo Manipulation in a Porcine Model of Intrinsic Sphincter Deficiency.” The Journal of Urology, 196:3; 934-942; 2016.
Borowski D et al. “Adipose Tissue-Derived Regenerative Cell-Enhanced Lipofilling for Treatment of Cryptoglandular Fistulae-in-Ano: The ALFA Technique.” Surgical Innovation, 22:6; 593-600; 2015.
Borowski D et al. “Autologous Adipose-Tissue Derived Regenerative Cells for the Treatment of Complex Cryptoglandular Fistula-in-Ano: A Report of Three Cases.” BMJ Case Reports; 2012.
Calabrase C et al. “Breast Reconstruction after Nipple/Areola- Sparing Mastectomy Using Cell-Enhanced Fat Grafting.” ecancer, 3:116; 2009.
Calcagni M et al. “The novel treatment of SVF-enriched fat grafting for painful end-neuromas of superficial radial nerve.” Microsurgery, 1-6; 2016.
Cervelli V et al. “Application of Enhanced Stromal Vascular Fraction and Fat Grafting Mixed with PRP in Post–Traumatic Lower Extremity Ulcers.” Stem Cell Research, 6:2; 103-111; 2011.
Choi J et al. “Adipose-Derived Regenerative Cell Injection Therapy for Postprostatectomy Incontinence: A Phase I Clinical Study.” Yonsei Medical Journal, 57:5; 1152-1158; 2016.
Daumas A et al. “Long-term follow-up after autologous adipose-derived stromal vascular fraction injection into fingers in systemic sclerosis patients.” Current Research in Translational Medicine, in press 2016.
Domenis R et al. “Adipose tissue derived stem cells: in vitro and in vivo analysis of a standard and three commercially available cell-assisted lipotransfer techniques.“ Stem Cell Research & Therapy, 6:2; 2015.
Feng Z et al. “Fresh and cryopreserved, uncultured adipose tissue-derived stem and regenerative cells ameliorate ischemia–reperfusion-induced acute kidney injury.” Nephrology Dialysis Transplantation, 25:12; 3874-3884; 2010.
Foll D et al. “Successful closure of persistent oro-cutaneous fistulas by injection of autologous adipose-derived stem cells: a case report.” German Plastic, Reconstructive and Aesthetic Surgery, 3:5; 2013.
Fraser J et al. “The Celution System: Automated Processing of Adipose-Derived Regenerative Cells in a Functionally Closed System.” Advances in Wound Care, 3:1; 38-45; 2014.
Gentile P et al. “A Comparative Translational Study: The Combined Use of Enhanced Stromal Vascular Fraction and Platelet-Rich Plasma Improves Fat Grafting Maintenance in Breast Reconstruction.” Stem Cells Translational Medicine, 1:4; 341–351; 2012.
Gentile P et al. “Breast Reconstruction with Enhanced Stromal Vascular Fraction Fat Grafting: What Is the Best Method?” Plastic and Reconstructive Surgery Global Open, 3:6; 2015.
Gentile P et al. “Adipose-derived stromal vascular fraction cells and platelet-rich plasma: basic and clinical evaluation for cell-based therapies in patients with scars on the face.” The Journal of Craniofacial Surgery, 25:1; 267-272; 2014.
Gotoh M et al. “Regenerative treatment of male stress urinary incontinence by periurethral injection of autologous adipose-derived regenerative cells: 1-year outcomes in 11 patients.” International Journal of Urology, 21; 294-300; 2014.
Granel B et al. “Safety, tolerability and potential efficacy of injection of autologous adipose-derived stromal vascular fraction in the fingers of patients with systemic sclerosis: an open-label phase I trial.” Annals of the Rheumatic Diseases, 2014.
Guillaume-Jugnot P et al. “Autologous adipose-derived stromal vascular fraction in patients with systemic sclerosis: 12-month follow-up.” Rheumatology, 55:2; 301-306; 2016.
Haahr M K et al. “Safety and Potential Effect of a Single Intracavernous Injection of Autologous Adipose-Derived Regenerative Cells in Patients with Erectile Dysfunction Following Radical Prostatectomy: An Open-Label Phase I Clinical Trial”. EBioMedicine, 5; 204-210; 2016.
Haahr M K et al. “Safety and Potential Effect of a Single Intracavernous Injection of Autologous Adipose-Derived Regenerative Cells in Patients with Erectile Dysfunction Following Radical Prostatectomy: A 12-Month Follow-Up.” The Journal of Urology, 197:4; e542; 2017.
Henry T et al. “The Athena Trials: Autologous Adipose-Derived Regenerative Cells for Refractory Chronic Myocardial Ischemia with Left Ventricular Dysfunction.” Catheterization and Cardiovascular Interventions, 2016.
Herold C et al. “Supplementation of fat grafts with adipose-derived regenerative cells in reconstructive surgery.” German Plastic, Reconstructive and Aesthetic Surgery, 2; 2012.
Houtgraaf J et al. “First Experience in Humans Using Adipose Tissue-Derived Regenerative Cells in the Treatment of Patients With ST-Segment Elevation Myocardial Infarction.” Journal of the American College of Cardiology, 59:5; 539-540; 2012.
Iddins CJ et al. “Case Report: Industrial X-Ray Injury Treated With Non-Cultured Autologous Adipose-Derived Stromal Vascular Fraction (SVF).” Health Physics, 111:2; 112-116; 2016.
Ito S et al. “Long-term outcome of adipose-derived regenerative cell-enriched autologous fat transplantation for reconstruction after breast-conserving surgery for Japanese women with breast cancer.” Surgery Today, 1-12; 2017.
Kakudo N et al. “Adipose-derived regenerative cell (ADRC)-enriched fat grafting: optimal cell concentration and effects on grafted fat characteristics.” Journal of Translational Medicine, 11:254; 1-9; 2013.
Kamakura T and Ito K. “Autologous Cell-Enriched Fat Grafting for Breast Augmentation.” Aesthetic Plastic Surgery, 35:6; 1022–1030; 2011.
Karaaltin M et al. “Adipose Derived Regenerative Cell Therapy for Treating a Diabetic Wound: A Case Report.” Wounds, 24:1; e1-5; 2012.
Magalon G et al. “Regenerative Approach to Scleroderma with Fat Grafting.” Clinics in Plastic Surgery, 42:3; 353-364; 2015.
Marino G et al. “Therapy with autologous adipose-derived regenerative cells for the care of chronic ulcer of lower limbs in patients with peripheral arterial disease.” Journal of Surgical Research, 185:1; 36-44; 2013.
Mizushima T et al. “A clinical trial of autologous adipose-derived regenerative cell transplantation for a postoperative enterocutaneous fistula.” Surgery Today, 46:7; 835-842; 2016.
Peltoniemi H et al. “Stem cell enrichment does not warrant a higher graft survival in lipofilling of the breast: a prospective comparative study.” Journal of Plastic, Reconstructive & Aesthetic Surgery, 66:11; 1494-1503; 2013.
Perez-Cano R et al. “Prospective Trial of Adipose-Derived Regenerative Cell (ADRC)-Enriched Fat Grafting for Partial Mastectomy Defects: The RESTORE-2 Trial.” European Journal of Surgical Oncology, 38:5; 382-389; 2012.
Perez-Meza D et al. “Hair follicle growth by stromal vascular fraction-enhance adipose transplantation in baldness.” Stem Cells and Cloning: Advances and Applications, 10; 1-10; 2017.
Perin E et al. “Adipose-derived regenerative cells in patients with ischemic cardiomyopathy: The PRECISE Trial.” American Heart Journal, 168:1; 88-95; 2014.
Prins H-J et al. “Bone Regeneration Using the Freshly Isolated Autologous Stromal Vascular Fraction of Adipose Tissue in Combination With Calcium Phosphate Ceramics.” Stem Cells Translational Medicine, 2016.
Sakai Y et al. “Phase I clinical study of liver regenerative therapy for cirrhosis by intrahepatic arterial infusion of freshly isolated autologous adipose tissue-derived stromal/stem (regenerative) cell.” Regenerative Therapy, 6; 52-64; 2017.
Saxer F et al. “Implantation of Stromal Vascular Fraction Progenitors At Bone Fracture Sites: From A Rat Model To A First-In-Man Study.” Stem Cells, 34:12; 2956-2966; 2016.
Shimizu S et al. “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.” BMC Urology, 17:89; 2017.
Smyshlyaev I et al. “Safety and Effectiveness of Intraarticular Administration of Adipose-Derived Stromal Vascular Fraction for Treatment of Knee Articular Cartilage Degenerative Damage: Preliminary Results of a Clinical Trial.” Traumatology and Orthopedics of Russia, 23:3; 17-31; 2017.
Sugimachi K et al. “Novel breast reconstruction procedure- Attempts of breast regeneration using stem cells after breast cancer mastectomy.” Japan Journal of Cosmetic Surgery, 30(3); 151-160; 2008.
Tiryaki T et al. “Staged Stem Cell-enriched Tissue (SET) Injections for Soft Tissue Augmentation in Hostile Recipient Areas: A Preliminary Report.” International Society of Aesthetic Plastic Surgery, 35:6; 965-971; 2011.
Toyserkani N et al. “Treatment of Breast Cancer-Related Lymphedema with Adipose-Derived Regenerative Cells and Fat Grafts: A Feasibility and Safety Study.” Stem Cells Translational Medicine, 2017.
Toyserkani N et al. “Cell-Assisted Lipotransfer Using Autologous Adipose-Derived Stromal Cells for Alleviation of Breast Cancer-Related Lymphedema.” Stem Cells Translational Medicine, 5:7; 857-859; 2016.
Tsekouras A et al. “Adipose-derived stem cells for breast reconstruction after breast surgery – preliminary results.” Case Reports in Plastic Surgery & Hand Surgery, 4:1; 35-41; 2017.
Yamamoto T et al. “Periurethral injection of autologous adipose-derived regenerative cells for the treatment of male stress urinary incontinence: Report of three initial cases.” International Journal of Urology, 19:7; 652-659; 2012.
Yokota N et al. “Clinical results following intra-articular injection of adipose-derived stromal vascular fraction cells in patients with osteoarthritis of the knee.” Regenerative Therapy, 6; 108-112; 2017.
Yoshimoto H et al. “Efficacy of patients’ own adipose-derived regenerative cells for chronic intractable radiation injuries.” Journal of Wound Technology, 10; 22-25; 2010.
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Peer Reviewed Publications 19 Nov 2017 20:19 #10590

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Sadly, so many of these are years old with no real pick up by anyone.
Why do these trials just lie there after their phase 1 readouts ?
So now we have to guess if any of these 2016 and 2017 papers trigger something positive or most collect dust like the others.
Too bad Hedrick didn't want to elaborate on any of these.
Where is the hinted liver trial ?

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Peer Reviewed Publications 20 Nov 2017 02:31 #10591

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Hi Hedge, with regard to your question as to why so many interesting phase I trials do not progress to phase II, it's quite simple, because they are undertaken by INDEPENDENT INVESTIGATORS. Their resources are limited and they are undertaking these trials as researchers doing cutting edge RESEARCH. They have no skin in the game, apart from academic kudos via publishing and tenure. It is the owners of the technology who stand to benefit from the further development process, provided they fund the additional research.

It is management that makes the sound :bash: (or otherwise) decisions of allocating shareholder's resources to successfully cross the finish line. It is this failure of MANAGEMENT that has allowed SO MUCH promising research to go unutillised. However let's no forget that scleroderma was originally an IIS.

We have had a number of trials succesfully treating fistula but all of them have been phase I. So many INDEPENDENT small trials with such positive results are NOT random.

IMO we have a superior product in terms of efficacy yet Tigenix has a market cap of $310M while we are at $13M . This disparity is primarily a reflection of management, not autologous ADRC efficacy. Admitedly as an autologous product requiring a lipo this may not be as attractive to patients but for anyone who has sufferred from an acute chronic fistula a lipo would be a walk in the park. Here are a couple of ''recent'' trials whose data should unequivocally justify a phase II/III trial.

onlinelibrary.wiley.com/doi/10.1111/codi.13555/abstract

www.ncbi.nlm.nih.gov/pubmed/26342817

Whether they move to phase II/III in he near future is purely dependent on management decisions. I wholeheartedly believe that the marginal cost of autologous ADRC can compete with allogeneic when one factors in relative efficacy. What will determine whether this happens or not is just a function of GREED and PRIDE (misplaced stubbornness) on the part of management.:puke:

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Peer Reviewed Publications 20 Nov 2017 03:44 #10592

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myownhedgefund wrote: Where is the hinted liver trial ?


Obviously that liver trial is on the ONGOING list - link HERE

8 patients- started in 2016 and to be finished in 2020.

But we already found the paper - (not on the foregoing list) - also produced by the Kaneko group at Kanazawa which (supposedly) followed the patients only for a few weeks. Why than that triggers this trial is somewhat curious....:whistle: :grin:

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Peer Reviewed Publications 20 Nov 2017 05:04 #10593

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Thanks Fas, I did see that.
I was hoping for something more than a small phase 1 w/o a control. Something that moved the needle beyond what Astellas was working on years ago.
I can only blame myself for allowing such a glimmer of hope.

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Peer Reviewed Publications 20 Nov 2017 07:00 #10594

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myownhedgefund wrote: Thanks Fas, I did see that.
I was hoping for something more than a small phase 1 w/o a control. Something that moved the needle beyond what Astellas was working on years ago.
I can only blame myself for allowing such a glimmer of hope.


The Polish studies, which I posted in the other topic about ongoing clinics were 40 patients and with a seldom used treatment method i.e. lasers for MI. When you - as you have indicated quite often- share the potential usefulness of ADRC´s in Acute MI, than one could reasonably assume, that with APOLLO and ADVANCE also available as clinical data and knowing the limited requirements of EMA i.e the AMTP regulatory pathway, significant value could be hidden in the IIS treasure.

Something I have always said and at one point in time considered suing Cytori about, which as we all know doesnt make sense if you own the stock yourself.

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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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