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TOPIC: Update on IIS around the Globe wih celution

Update on IIS around the Globe wih celution 13 Nov 2017 08:15 #10485

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Nov 13, 2017
Updates on Other Selected Global Investigator Initiated Trials

SAN DIEGO, Nov. 13, 2017 (GLOBE NEWSWIRE) -- Cytori Therapeutics, Inc. (Nasdaq:CYTX) (“Cytori” or “the Company”) today announced a new investigator initiated U.S. clinical trial for hip osteonecrosis. Details of the trial can be assessed at https://clinicaltrials.gov/ct2/show/NCT03269409 .

Cytori Cell Therapy™ technology is approved for use in many countries around the world and has been shown to be safe and clinically useful in many indications. As a result, besides Cytori sponsored clinical trials such as the STAR trial for scleroderma, on a highly selective basis, the Company partners with researchers, academic institutions, and private institutions to support Investigator Initiated Studies (IIS). In these unsolicited, independent clinical or scientific research programs, the sponsor generally provides the majority of the overall trial support while Cytori typically supplies the core cell therapy technology.


  • Recently, the U.S. FDA approved a trial of Cytori Cell Therapy in up to 25 patients with bilateral osteonecrosis of the hip ( /NCT03269409 ). According to Cleveland Clinic, osteonecrosis of the hip is a rare disease that affects ~10,000-20,000 new patients each year in the U.S. With osteonecrosis of the hip, disruption of the blood supply leads to loss of bone-forming cells within the hip resulting in progressive weakening and even death of the bone. Over time this can progress to collapse of the hip bone, debilitating pain, and loss of mobility. Hip decompression involves surgical removal of dead and dying bone to create a space in which new blood vessels and new bone can regenerate with the goal of restoring the structural integrity of the hip. Despite this treatment, many patients go on to require complete hip replacement, often at a relatively young age. This evolved from the combination of Cytori’s U.S. ACT-OA clinical trial ( NCT326961 ) and an earlier trial in Europe which reported evidence of new bone formation in patients receiving Cytori Cell Therapy in both dental surgery and in osteoporotic fracture repair. This U.S. trial will assess the ability of Cytori Cell Therapy to provide benefit in patients with osteonecrosis of the hip. The hope is that improved formation of new bone and blood vessels within the diseased hip will lead to more robust bone regeneration and thereby delay or even eliminate the need for later hip replacement surgery. Cytori is supporting this IIS and believes that the 1st patient may be enrolled by the end of 2017.


  • The SCLERADEC-2 trial in France ( /NCT02558543 ) of Cytori’s Habeo Cell Therapy™ for patients with hand dysfunction due to scleroderma continues to enroll, with 32 patients enrolled out of a target of up to 40. Earlier this year, French regulatory authorities approved a 3rd center (Hôpital Saint-Louis, Paris) to add to the 2 centers (Assistance Publique Hôpitaux de Marseille and CHU de Rouen) currently treating patients. The Marseille investigators anticipate completing enrollment by the end of 2017. This trial has a 6 month follow-up period with the Cochin Hand Function Score at 3 months as the primary endpoint. A novel aspect of SCLERADEC-2 is the inclusion of a crossover design in which, at the end of the trial, patients enrolled in the placebo arm can be treated with banked, cryopreserved Habeo Cell Therapy, harvested at the time of their initial enrollment in the study. This arm will capture exploratory data that may be valuable for implementation of a future repeated treatment model for patients requiring only a single tissue harvest procedure for multiple therapies.


  • In September 2017, investigators from the Department of Urology at Nagoya University in Japan published the protocol for the presently enrolling ADRESU trial ( /NCT02529865 ) of Cytori’s ECCI-50 Cell Therapy in male patients with stress urinary incontinence (SUI) following radical prostatectomy. ADRESU is an open-label, multi-center, single arm trial approved by Japan’s Ministry of Health, Labour and Welfare. This trial is primarily sponsored and funded by the Japanese government, including by a grant provided by Japan’s Agency for Medical Research and Development. The investigators have treated 35 of the targeted 45 patients. The investigators anticipate complete enrollment by the end of 2017 or early 2018. ADRESU is the 1st trial of a regenerative treatment for SUI patients using ECCI-50 Cell Therapy performed under Japan’s Pharmaceutical Affairs Act. Once the trial is completed successfully, Cytori intends to work with the team at Nagoya University to submit the ADRESU data to Japan’s Pharmaceuticals and Medical Devices Agency for approval to market this form of Cytori Cell Therapy for SUI. ADRESU is a follow-up study of the previously published pilot study in this indication by the Nagoya team. This pilot study data was subsequently confirmed and published by an independent team in South Korea, also using ECCI-50 Cell Therapy.

  • In addition to the aforementioned investigator initiated trials, many other investigators are currently conducting research with the Cytori Cell Therapy platform for a broad range of clinical indications:

    Country Clinical Indication

    Denmark Erectile Dysfunction (NCT02240823)
    Denmark Lymphedema (NCT02592213)
    France Crohn’s Disease ( https://www.clinicaltrials.gov/ct2/show/NCT02520843?term=fistula+adipose&rank=18NCT02520843 )
    France Diabetic Foot Ulcer ( https://clinicaltrials.gov/ct2/show/NCT02866565 )
    France Vocal Cord Scarring (NCT02622464)
    Japan Atherosclerosis Obliterans, Buerger’s Disease, Collagen Disease ( UMIN00001010143UMIN000010143 )
    Japan Heart Failure (UMIN000009066)
    Japan Intra Cerebral Hemorrhage
    Japan Liver Cirrhosis (UMIN000022601)
    Japan Stroke
    Poland Acute Myocardial Infarction (see posts below)
    Poland Amyotrophic Lateral Sclerosis ( https://clinicaltrials.gov/ct2/show/NCT03296501 )
    Poland Breast Reconstruction
    Poland Burn
    Poland Diabetic Foot Ulcer
    Russia Anterior Cruciate Ligament Partial Rupture (NCT02469792)
    Russia Erectile Dysfunction (NCT02472431)
    Russia Glaucoma (NCT02144103)
    Russia Knee Osteoarthritis (NCT02219113)
    Spain Meniscus Repair
    In summary, these investigator initiated trials, typically performed at leading institutions in the U.S., Japan, and Europe, provide useful preliminary safety and efficacy data into novel therapeutic approaches for Cytori Cell Therapy. In fact, Cytori’s Habeo therapy was developed initially through an investigator initiated clinical trial. For more information about these trials, please visit Cytori’s website at cytori.com/researchers. Furthermore, the results from some of these trials are listed on Cytori’s website at cytori.com/our-technology/#publications.

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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:

    Update on IIS around the Globe wih celution 13 Nov 2017 08:29 #10486

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    Aside from the new trial for the Hip, it's amazing how many other investigators around the world are currently conducting research with the Cytori Cell Therapy platform (20 listed)!!

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    Update on IIS around the Globe wih celution 13 Nov 2017 08:59 #10488

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    This Polish study sounds quite interesting:

    Use of medical lasers and stem cells in the extreme form of ischemic heart disease - FAT-TLMR



    The project is funded by the National Science Center.

    Program: OPUS

    Total project amount: 1 035 456,00 PLN, including:

    grant amount: 1 035 456,00 PLN

    own contribution: 0,00 PLN

    Project implementation: 07.12.2012 - 06.12.2017

    Short description of the project:

    The purpose of the study will be to demonstrate that the administration of stem cells from adipose tissue in an annualized study will improve regional cardiac contractility in patients with end-stage coronary heart disease ineligible for conventional cardiac revascularisation. Evaluation of the mechanism of stem cell differentiation, myocardial infarction, and local inflammatory effects will be extremely valuable information for the development of medical knowledge of stem cells. The effectiveness of therapy is crucial for patients with dissimilar CAD and provides them with a chance for better and longer lives without the symptoms of angina pectoris. 40 Patients with terminal ischemic heart disease (CHNS) will be included in the study. There is no possibility of complete and immediate cardiac revascularisation (percutaneous PCI or coronary artery bypass grafting), and despite optimum medical therapy, patients still have stenocardial ailments (CCS III or IV). The study will evaluate the efficacy and safety of the use of medical lasers and stem cells in the treatment of ischemic heart disease.

    The results of the project are planned to evaluate the mechanism of differentiation of stem cells, given to the myocardium. The effectiveness of therapy is crucial for patients with disseminated coronary disease and can give patients a better and longer life without symptoms of angina pectoris. In addition, the project can contribute to reducing the financial burden on healthcare by reducing the number of hospitalizations.

    Project Manager: Prof. dr hab. Jerzy Sadowski, MD
    Attachments:

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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:

    Update on IIS around the Globe wih celution 13 Nov 2017 09:16 #10490

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    The timing of the release may very likely stimulate further interest in the RO - in any event, I am in - maybe the only one on this MB!

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    Update on IIS around the Globe wih celution 13 Nov 2017 09:42 #10491

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    rodney.strongg wrote: The timing of the release may very likely stimulate further interest in the RO - in any event, I am in - maybe the only one on this MB!


    As I stated in my post RS, can’t see the advantage of the RO when you could take the 1K and purchase 2,500 shares at today’s market. Perhaps you could provide me with a little education but common sense tells me to not put anymore into this until they start producing more than press releases.

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    Update on IIS around the Globe wih celution 13 Nov 2017 12:05 #10493

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    B-7, see my earlier post replying to you under a different category.

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    Update on IIS around the Globe wih celution 13 Nov 2017 14:19 #10495

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    The timing of the release may very likely stimulate further interest in the RO - in any event, I am in - maybe the only one on this MB!




    Certainly that is the motivation by Cytori to put out this press release. They need cash and at least we know now that they convinced one shareholder. Somebody is excited!!

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    Update on IIS around the Globe wih celution 13 Nov 2017 14:53 #10496

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    Truth is that I was going to do it before today's release!

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    Update on IIS around the Globe wih celution 14 Nov 2017 06:32 #10501

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    fas wrote: This Polish study sounds quite interesting:

    Use of medical lasers and stem cells in the extreme form of ischemic heart disease - FAT-TLMR



    Project implementation: 07.12.2012 - 06.12.2017

    Short description of the project:

    The purpose of the study will be to demonstrate that the administration of stem cells from adipose tissue in an annualized study will improve regional cardiac contractility in patients with end-stage coronary heart disease ineligible for conventional cardiac revascularisation. Evaluation of the mechanism of stem cell differentiation, myocardial infarction, and local inflammatory effects will be extremely valuable information for the development of medical knowledge of stem cells. The effectiveness of therapy is crucial for patients with dissimilar CAD and provides them with a chance for better and longer lives without the symptoms of angina pectoris. 40 Patients with terminal ischemic heart disease (CHNS) will be included in the study. There is no possibility of complete and immediate cardiac revascularisation (percutaneous PCI or coronary artery bypass grafting), and despite optimum medical therapy, patients still have stenocardial ailments (CCS III or IV). The study will evaluate the efficacy and safety of the use of medical lasers and stem cells in the treatment of ischemic heart disease.

    The results of the project are planned to evaluate the mechanism of differentiation of stem cells, given to the myocardium. The effectiveness of therapy is crucial for patients with disseminated coronary disease and can give patients a better and longer life without symptoms of angina pectoris. In addition, the project can contribute to reducing the financial burden on healthcare by reducing the number of hospitalizations.

    Project Manager: Prof. dr hab. Jerzy Sadowski, MD


    Cytori lists this study (which should be virtually completed) as Infarction clinic and not a chronic clinic. I assume the laser therapy is used to substitute either CABG (bypass surgery) or percutaneous intervention (catheter). This is also done in the Western regions of the world in case of rather small inflicted coronary vessels. The other possibility relates to irradiation, which is known to proliferate endothelial cells.

    Anyway- we might hear more on this at a later stage. I am kind of excited about this, since I always saw MI as the primary application for ADRC´s i.e. perfectly suited for it in respect of its mechanisms for therapeutic healing and I always have been more than annoyed by the fact that Cytori never has given us efficacy data on ADVANCE.

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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:

    Update on IIS around the Globe wih celution 14 Nov 2017 06:51 #10502

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    The other Polish clinic on ALS or Lou Gehrig´s disease is also quite exciting- the rest of the linked clinics we already were aware of. Remains to say- approximately 30 other IIS studies have been completed in the meantime- approx. 5- 6 papers exists with peer reviewed results and Cytori themselves stated in January 2017, they would start a "bone repair" trial. That - until they acquired Azaya and the money issues became even more apparent.

    Anyway- from the linked filing at clinicaltrials.gov-

    Amyotrophic Lateral Sclerosis (ALS) is an incurable disease of unknown etiology that in a short time leads to significant impairment of motor functions and death. The frequency of ALS is 4-8/100 000. Mostly it affects people between 40 and 70 years old, but it can occur at a younger age. Since the symptom onset is most frequently in the fifth or sixth decade, ALS is a huge economic burden for the society. There are many studies conducted to treat the disease and prevent it, but currently the medicine offers only one drug that can slow the appearance of disease symptoms but could not stop the progression. Yet, improvements in medical management, including nutrition and breathing, regularly increase patient survival - 50% of affected patients live at least 3 or more years after diagnosis; 20% live 5 years or more; and up to 10% will survive more than 10 years. The stem-cell-based therapies could be therefore a new waited strategy for ALS clinical treatment.
    Since the clinical course of ALS may vary substantially between patients, we are planning to qualify them with a primarily established clinical course based on a detailed anamnesis and clinical assessment. The goal of our nonrandomized, open label study is to investigate the safety and efficacy of autologous adipose derived mesenchymal regenerative cells (ADRC) transplantation into the individuals with diagnosed amyotrophic lateral sclerosis. In order to select a group of 30 ALS patients for the ADRC treatment, approximately 50 ALS patients will be examined. All patients enrolled will have a documented at least 3-months clinical and electrophisiological observation of ALS disease course prior to study enrollment. Each patient will recive 3 injections of ADRC every 3 months: an intraspinal injection followed by 2 subsequent intrathecal infusions. Safety, adverse events and efficacy will be confirmed by clinical, elecrophisiological ( EMG, MUNIX), neuroimmaging and spirometry together with functional (ALSFRS-R) and objective motor assesment (MRC and dynamometer).

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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:

    Update on IIS around the Globe wih celution 14 Nov 2017 06:58 #10503

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    Fas
    Agree acute vs chronic likely the best use of Cytori's tech in cardiac.
    Its just sooo far away.

    I was hoping for more of a discussion than a simple press release with these studies.
    Oh well.

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    Update on IIS around the Globe wih celution 08 Feb 2018 11:50 #11182

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    Seems the list of IIS studies have been taken off the Cytori Homepage again. At least it is still here, since I copied it. I will keep an eye on developments, but sofar- I must admit- progress seems to be rather slow.

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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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