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Adult Stem Cell News and Developments other than Cytori
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TOPIC: Ingeneron News

Ingeneron News 19 Sep 2017 07:26 #10052

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I find that this company, is the antithesis of Cytori. Exact same technology but got there without the bloated payroll and $300MM down the tubes. Still moving forward. No numbers though because they are backed by German private investors.

HOUSTON, Texas & MUNICH--(BUSINESS WIRE)--InGeneron, Inc., a regenerative medicine and biotechnology company, today announced the publication of results from an investigator initiated case series in chronic leg wounds in the Journal of the European Academy of Dermatology and Venereology. In the case series, InGeneron’s proprietary adipose-derived regenerative cell (ADRC) technology was used for the treatment of chronic venous leg ulcers and mixed arterial-venous ulcers, the most common types of chronic leg wounds in the Western world, especially among elderly patients. Both conditions are associated with severe pain impairing quality of life and complex as well as time-consuming treatment regimes. The case series was conducted in collaboration with the Department of Dermatology at the University Hospital rechts der Isar Munich, led by Principal Investigator Alexander Konstantinow, MD, Dipl. Chem., and was published in the Journal of the European Academy of Dermatology and Venereology, one of the leading journals in its field. The publication titled “Therapy of ulcus cruris of venous and mixed venous arterial origin with autologous, adult native progenitor cells from subcutaneous adipose tissue: a prospective clinical pilot study” can be accessed through this link.

“Chronic leg wounds are associated with a complicated disease progression and severe pain, impairing quality of life. Current treatment options are complex, time consuming and require high medical expenses. New therapeutic interventions that improve outcomes in these patients could have an important therapeutic impact,” said Alexander Konstantinow, MD, Dipl. Chem., senior physician at the Department of Dermatology and Allergology at Technical University Munich, Germany, and the primary investigator of the study. “The results that we have achieved in this case series are remarkable because we have been able to restore wound healing capabilities and decrease pain in multimorbid patients with large venous and mixed arterial-venous ulcers with an one-time minimally invasive application, while demonstrating a very good safety and tolerability profile. InGeneron’s point-of-care system has the potential to benefit a large number of patients with wound healing disorders of vascular origin, while being more cost effective compared to currently available standards of care.”

The case series comprised 16 multimorbid leg ulcer patients (12 male, 4 female) ranging in age from 52 to 84 years who were treated with autologous ADRCs prepared at point-of-care with InGeneron’s Transpose® RT system. 7 patients were presenting with venous leg ulcers, 9 with mixed arterial-venous ulcers. Within 10 to 25 weeks, 11 out of the 16 patients showed complete wound closure. All 7 venous leg ulcers patients showed complete epithelialization. Moreover, the group of venous ulcer patients reported significant pain decrease by more than 90 percent 14 days post treatment. After 9 to 44 months of follow-up across all patients, no severe side effects were observed, demonstrating good overall safety and tolerability of the therapy in this patient population.

“This case series marks the next step in our journey to establish clinical evidence of how adipose-derived regenerative cells impact inflammation and pain as well as support healing in chronic wounds,” said Ron Stubbers, President of InGeneron. “These encouraging results highlight the potential of our regenerative cell therapy approach in wound healing.”

Based on the results of the investigator initiated study InGeneron plans to initiate a FDA feasibility study in the US in the near-term. The prospective, randomized, single-site study will investigate the safety and tolerability of InGeneron’s point-of-care regenerative cell therapy in venous leg ulcer patients. More information about the study can be found on www.clinicaltrials.gov or via this link.

About InGeneron

InGeneron is elevating the field of regenerative medicine by translating robust science into proven patient benefit. Our purpose is to set new therapeutic standards by enabling physicians to use the patients’ own regenerative cells at point of care. With the initial focus on key orthopedic and wound healing indications, we will make regenerative cell therapies broadly accessible across multiple medical fields. www.ingeneron.com

Contacts
InGeneron
Ron Stubbers
President
+1 713 440 9900
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Media Inquiries
Stephanie May
MacDougall Biomedical Communications
+ 49 89 2420 9344 or +49 175 571 1562
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Ingeneron News 19 Sep 2017 08:48 #10053

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Early but pretty good response numbers.
Chronic wounds a large market and will be hard to break into at first with so much already on the market but if this does ultimately pass to approvals they will get their piece. This is where I always felt Cytori's use in burns would be best and likely mostly used...the chronic hard to heal stuff.

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Ingeneron News 19 Sep 2017 08:58 #10054

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Perhaps not a complete antithesis as they too shift and search for management but maybe they will do it early enough and then indeed unlike Cytori before the company is run into the ground.
Ingeneron earlier this year :

***Houston, TX, USA, February 14, 2017 – InGeneron, Inc., a regenerative medicine and cell therapy company, today announced changes in its leadership team. Michael Coleman, PhD, has stepped down as President and CEO and will join InGeneron’s Scientific Advisory Board. Ron Stubbers, MBA, formerly InGeneron’s Vice President of Operations, has been appointed President. The company has started the search process for candidates to replace Dr. Coleman as CEO. The company also announced the appointment of Glenn Winnier, PhD, as Chief Scientific Officer.
“InGeneron has reached an important stage of its development and the timing is right to bring in new management as well as to benefit from a smooth transition with Ron’s leadership as President. We are also pleased to welcome Glenn, who brings extensive clinical experience, which is the primary focus for the company moving forward,” stated Eckhart Alt, MD, PhD, Chairman of the InGeneron Board of Directors. “Michael successfully led the evolution of InGeneron. We thank him for his contributions and are happy to continue our collaboration as he will join the Scientific Advisory Board.”
“It is exciting to accept the position of President as we advance our clinical trial development plans in wound healing and orthopedic indications. My goal is to ensure effective operational support for establishing the therapeutic value of our approach and I believe 2017 will be transformative for the company,” added Mr. Stubbers.
Joining the company as new CSO, Dr. Winnier has over 18 years of experience in scientific leadership and a proven track record in the design of studies which have led to the successful commercialization of novel therapeutics. Glenn Winnier holds a PhD in cell biology from Vanderbilt University. He joins InGeneron from Memorial Hermann Healthcare System in Houston where he was Director of Clinical Research Operations at the Clinical Innovation and Research Institute.***

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Ingeneron News 21 Sep 2017 05:11 #10064

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Wall Street Titan wrote: I find that this company, is the antithesis of Cytori. Exact same technology but got there without the bloated payroll and $300MM down the tubes. Still moving forward. No numbers though because they are backed by German private investors.


I find it very difficult to assess where they are going and what their goals are. They are certainly not anywhere near to where Cytori is- i.e. they have no clinical data which underlie zje scrutiny of the FDA at least.

To explain- I know Ingeneron for ages. The Company was founded by Professor Eckhart Alt, who did the cardiac pig studies at Tulane for Cytori. Since Tulane used to be a primary centre for ADRC research in those days- 2006/7 he stuck with the tech and after doing some other stuff started up Ingeneron in Houston.

You will find 4 entries at clinicaltrial.gov for Ingeneron as sponsor for clinical trials in the US- 3 orthopedic ones- which were collaborations with clinics but without FDA involvement.

The last one-similar stuff as reported above (München is Alt´s home- university) they started recently in the US on a small scale- but again without FDA involvement.

Maybe they are gambling on more liberal regulatory rules in Texas or wanted to pick along some grains when Cytori would be successful which we now know- is a long way off if ever. I do not know- but presently my assessment is that they are going nowhere just like BioHeart. I mean before being allowed to start an FDA supported trial, you have to produce pre-clinical data and scientific studies. Example- Cytori had quite a lot of human data on burn - and radiation wound healing from the Akita and other IIS studies. Still for the BARDA contract they had to go back to piggies to prove the tech on animals and some other stuff. That took 4 years and small Companies cannot afford them obviously.

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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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