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Stem cells for diabetic foot ulcers

Discussion in 'Diabetic Foot & Wound Management' started by NewsBot, Apr 21, 2009.

  1. NewsBot

    NewsBot The Admin that posts the news.

    Articles:
    1
    CHALLENGE OF MESENCHYMAL STEM CELLS AGAINST DIABETIC FOOT ULCER.
    Sener LT, Albeniz I.
    Curr Stem Cell Res Ther. 2015 May 18
     
  2. NewsBot

    NewsBot The Admin that posts the news.

    Articles:
    1
    Measurements of CD34+/CD45-dim Stem Cells Predict Healing of Diabetic Neuropathic Wounds
    Stephen R. Thom et al
    Diabetes February 2016 vol. 65 no. 2 486-497
     
  3. NewsBot

    NewsBot The Admin that posts the news.

    Articles:
    1
    Generation of Induced Pluripotent Stem Cells from Diabetic Foot Ulcer Fibroblasts Using a Nonintegrative Sendai Virus.
    Gerami-Naini B et al
    Cell Reprogram. 2016 Jun 21
     
  4. NewsBot

    NewsBot The Admin that posts the news.

    Articles:
    1
    This clinical trial was just registered:
    A Clinical Study Using Adipose-derived Stem Cells for Diabetic Foot
     
  5. NewsBot

    NewsBot The Admin that posts the news.

    Articles:
    1
    This clinical trial was just registered:
    Mesenchymal Stromal Cell Derivatives in the Treatment of Chronic Diabetic Foot Ulcers Type 1 and 2 (MSCDTDFU)
     
  6. NewsBot

    NewsBot The Admin that posts the news.

    Articles:
    1
    Press Release:
    Wound healing : the stem cell dynamics
    28 February 2017 Libre de Bruxelles, Université
    Researchers at the Université libre de Bruxelles, ULB define for the first time the changes in the stem cell dynamics that contribute to wound healing.
     
  7. NewsBot

    NewsBot The Admin that posts the news.

    Articles:
    1
    Mesenchymal Stem Cells Improve Healing of Diabetic Foot Ulcer
    Yue Cao, Xiaokun Gang, Chenglin Sun, and Guixia Wang
    Journal of Diabetes Research; Volume 2017, Article ID 9328347, 10 pages
     
  8. NewsBot

    NewsBot The Admin that posts the news.

    Articles:
    1
    PUBLIC RELEASE: 29-MAY-2017
    Healing wounds with cell therapy
    An experimental treatment in mice allows the reprogramming of blood cells in order to promote the healing process of cutaneous wounds. This approach could prove to be beneficial in healing challenging wounds in diabetics and major-burn victims.

    Montreal, May 29, 2017 - Diabetic patients frequently have lesions on their feet that are very difficult to heal due to poor blood circulation. In cases of serious non-healing infections, a decision to amputate could be made. A new therapeutic approach, presented recently in the Journal of Investigative Dermatology by Canadian researchers affiliated with the University of Montreal Hospital Research Centre (CRCHUM), could prevent these complications by promoting wound healing.

    The solution isn't what you might expect, not just another antibiotic ointment or other prescription medication. It's the approach that's different, a way to heal through personalized medicine. "We discovered a way to modify specific white blood cells - the macrophages - and make them capable of accelerating cutaneous healing," explained nephrologist Jean-François Cailhier, a CRCHUM researcher and professor at the University of Montreal.

    It has long been known that macrophages play a key role in the normal wound healing process. These white cells specialize in major cellular clean-up processes and are essential for tissue repair; they accelerate healing while maintaining a balance between inflammatory and anti-inflammatory reactions (pro-reparation).

    "When a wound doesn't heal, it might be secondary to enhanced inflammation and not enough anti-inflammatory activity," explained Cailhier. "We discovered that macrophage behaviour can be controlled so as to tip the balance toward cell repair by means of a special protein called Milk Fat Globule Epidermal Growth Factor-8, or MFG-E8."

    Cailhier's team first showed that when there is a skin lesion, MFG-E8 calls for an anti-inflammatory and pro-reparatory reaction in the macrophages. Without this protein, the lesions heal much more slowly. Then the researchers developed a treatment by adoptive cell transfer in order to amplify the healing process.

    Adoptive cell transfer consists in treating the patient using his or her own cells, which are harvested, treated, then re-injected in order to exert their action on an organ. This immunotherapeutic strategy is usually used to treat various types of cancer. This is the first time it has been shown to also be useful in reprogramming cells to facilitate healing of the skin.

    "We used stem cells derived from murine bone marrow to obtain macrophages, which we treated ex vivo with the MFG-E8 protein before re-injecting them into the mice, and we quickly noticed an acceleration of healing," said Dr. Patrick Laplante, Cailhier's research assistant and first author of the study.

    Added Dr. Cailhier, "the MFG-E8 protein, by acting directly upon macrophages, can generate cells that will orchestrate accelerated cutaneous healing."

    The beauty of this therapy is that the patient (in this case the mouse) is not exposed to the protein itself. Indeed, as Dr. Cailhier explained, "if we were to inject the MFG-E8 protein directly into the body there could be effects, distant from the wound, upon all the cells that are sensitive to MFG-E8, which could lead to excess repair of the skin causing aberrant scars named keloids. The major advantage [of this treatment] is that we only administer reprogrammed cells, and we find that they are capable of creating the environment needed to accelerate scar formation. We have indeed discovered the unbelievable potential of the macrophage to make healing possible by simple ex vivo treatment."

    What now remains to be done is to test this personalized treatment using human cells. Thereafter, the goal will be to develop a program of human cell therapy for diabetic patients and for victims of severe burns. It will take several years of research before this stage can be reached.

    This advanced personalized treatment could also make all the difference in treating cases of challenging wounds. According to the World Health Organization, diabetes affects 8.5% of the global population, and amputation rates of the lower extremities are 10 to 20 times higher in diabetics. "If, with this treatment, we can succeed in closing wounds and promoting healing of diabetic ulcers, we might be able to avoid amputations," Dr. Cailhier said.

    "Serious burn victims could also benefit," he added. "By accelerating and streamlining the healing of burns, we may be able to reduce the infections and keloids that unfortunately develop much too often in such patients." Cancer patients requiring extensive reconstruction surgery could also benefit, he said.

    ###

    About this study

    The study "MFG-E8 reprogramming of macrophages promotes wound healing by increased bFGF production and fibroblast functions" was published on May 16 in the Journal of Investigative Dermatology. Jean-François Cailhier, a nephrologist and researcher at the University of Montreal Hospital Research Centre (CRCHUM), holds the Claude Bertrand Chair in Neurosurgery of the University of Montreal, and is a professor at the University of Montreal and member of the Institut du cancer de Montréal. The other authors are: Patrick Laplante, Frédéric Brillant-Marquis, Marie-Joëlle Brissette, Benjamin Joannette-Pilon, Romain Cayrol and Victor Kofta. This study was funded by the Institut du cancer de Montréal (ICM). For additional information, we invite you to read the study: DOI: http://dx.doi.org/10.1016/j.jid.2017.04.030

    Source: University of Montreal Hospital Research Centre (CRCHUM)
     
  9. NewsBot

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    Articles:
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  10. NewsBot

    NewsBot The Admin that posts the news.

    Articles:
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    Press Release:
    VM BioPharma Announces First Patient Dosed in Phase 3 Study of Gene Therapy Candidate VM202 for Non-Healing Diabetic Foot Ulcers
    First Pivotal Gene Therapy Trial to Target Underlying Peripheral Artery Disease in Non-Healing Diabetic Foot Ulcers


    ATLANTA, Aug. 3, 2017 /PRNewswire/ -- VM BioPharma, the United States division of ViroMed Co., Ltd. in Seoul, Korea (KOSDAQ: 084990), today announced the first patient was dosed in the recently initiated Phase 3 clinical study evaluating VM202, a proprietary, DNA-based biopharmaceutical product, in patients with non-healing diabetic foot ulcers (NHU) and concomitant peripheral artery disease (PAD).

    This is the first pivotal gene therapy trial specifically targeting diabetic foot ulcers with underlying involvement of peripheral arteries. Foot ulcers are a significant complication of diabetes in which neuropathy, PAD and mechanical changes in the bony architecture of the foot result in skin and soft tissue breakdown. Results of a Phase 2 trial published in the journal Gene Therapy demonstrated that VM202 injections have the potential to treat foot ulcers in patients with critical limb ischemia, with complete wound closure occurring in 52 and 62 percent of treated patients.

    "We are truly excited at launching this pivotal clinical trial using VM202 for diabetic foot ulcers. This is a unique and promising approach to addressing non-healing wounds, and a positive outcome could be revolutionary in a population with limited or no options for improving their chance of complete ulcer healing," said Dr. David Armstrong, DPM, MD, PhD, distinguished outreach professor of surgery at the University of Arizona and director of the Southwestern Academic Limb Salvage Alliance (SALSA), who is serving as co-principal investigator of the Phase 3 study. "These wounds impose an enormous burden of care to patients, caretakers, and providers; 25 percent may progress to gangrene or amputation, and the five-year mortality rate equals that of many cancers."

    Dr. Emerson Perin, MD, PhD, Director of Clinical Research at the Texas Heart Institute and co-principal investigator of this trial, expressed that, "there have been a lot of ups and downs in developing potential therapeutic applications of growth factors. However, VM202 produced consistently positive results in our Phase 1 and 2 trials, and I am delighted to continue its clinical development into Phase 3."

    VM202 is a plasmid DNA that contains the human hepatocyte growth factor (HGF) gene, which in vivo produces two isoforms of HGF proteins that are naturally found in the human body. HGF is a growth factor that induces angiogenesis and acts as a neurotrophic factor to the peripheral nervous system. After VM202 is injected into a patient's muscle, it is taken up by cells which produce HGF protein. When released from skeletal muscle cells, HGF may induce new blood vessel formation locally by activating various signaling pathways. In this way, VM202 is believed to provide clinical benefit to patients with diabetic NHU.

    "This milestone marks the start of the second Phase 3 study for VM202, the first being a pivotal trial for painful diabetic peripheral neuropathy," said Dr. Sunyoung Kim, chief scientific officer of ViroMed Co., Ltd. "There have been numerous efforts to treat foot ulcers, mostly involving complex wound dressings; VM202 stands to alter the lower leg's ischemic environment, one of the critical causes of this condition, and these pivotal data will help us better understand the potential of this novel approach that could improve the quality of life for the millions of patients who suffer from this debilitating condition."

    Study Design:
    The Phase 3, double-blind, randomized, placebo-controlled, multicenter study is designed to assess the safety and efficacy of VM202 in 300 adult patients with a diabetic foot ulcer and concomitant PAD. Patients will be randomized in a 2:1 ratio to either VM202 (n=200) or placebo (n=100) and will receive ongoing wound care for the duration of the trial. The primary clinical efficacy outcome will be the proportion of subjects with confirmed target wound closure by the 4-month follow-up. Secondary endpoints will include changes in ankle-brachial index and toe-brachial index. For more information on this study, please visit ClinicalTrials.gov and reference Identifier NCT02563522.

    About Diabetic Non-Healing Foot Ulcers (NHU):
    Diabetic foot ulcers initially form when trauma, pressure loading, and/or neuropathy result in skin and soft tissue breakdown. Non-healing foot ulcers occur when wounds fail to heal despite appropriate care. The majority (approximately 90 percent) of NHU occur in patients with diabetes, 10 – 50 percent of whom have concomitant peripheral arterial disease (PAD).1-7 Foot ulcers may be difficult to heal, since the underlying metabolic derangements of diabetes, neuropathy and PAD are not reversed with standard wound care measures. The lifetime risk of developing non-healing foot ulcers for individuals with diabetes is 15 – 25 percent and doubles with concomitant PAD; recurrence rates within five years are 50 – 70 percent.2,3,4,8-11

    Current standard of care includes debridement of the wound, management of any infection, revascularization procedures when indicated, mechanical offloading of the ulcer, blood glucose control, and foot care education. These strategies result in healing approximately 50 percent of ulcers, while 25 percent of open wounds progress to gangrene or require amputation.

    About VM202:
    VM202 is a proprietary gene therapy from ViroMed targeting four different indications. When injected into patients, VM202 produces hepatocyte growth factor (HGF) protein, which induces angiogenesis and acts as a neurotrophic factor, leading to the formation of new microvasculature and inducing regeneration of nerve cells. The results from a Phase 2 study in critical limb ischemia showed that the two VM202 treatment groups had statistically significant complete wound closure and wound improvement rates over placebo at the 12-month follow-up (Gene Therapy 2016, 23: 306-12).

    VM202 also completed a successful Phase 2 study for painful diabetic peripheral neuropathy(Annals of Clinical and Translational Neurology 2015, Volume 2, Issue 5, 465–478), leading to an ongoing Phase 3 study (NCT02427464); and has successfully completed a phase 1/2 study for amyotrophic lateral sclerosis (ALS) in the U.S. A Phase 2 trial is also launching in Korea for the indication of coronary artery disease.

    About VM BioPharma and ViroMed Co., Ltd:
    VM BioPharma is the U.S. division of ViroMed Co., Ltd., an R&D focused biopharmaceutical company founded in 1996 and based in Seoul, Korea. ViroMed is developing new and innovative biopharmaceuticals for the treatment of currently untreatable diseases. The company is actively focusing development on the proprietary plasmid DNA-based drug VM202 in cardiovascular and neurological diseases at various clinical stages in the U.S., Korea, and China.

    ViroMed has assembled a diverse yet technologically- and conceptually-linked pipeline. Other research areas include antibody-based cancer therapeutics, immune disorders, recombinant protein-based thrombocytopenia treatment, and CAR-T technology. With a proven track record of clinical efficacy and quality molecular biological research, ViroMed aims to become the trailblazer in the field of gene therapy.
     
  11. NewsBot

    NewsBot The Admin that posts the news.

    Articles:
    1
    Meta-analysis on the treatment of diabetic foot ulcers with autologous stem cells.
    Guo J et al
    Stem Cell Res Ther. 2017 Oct 16;8(1):228. doi: 10.1186/s13287-017-0683-2.
     
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