This clinical study is designed to investigate the safety and potential ability of relocated autologous SVF (stromal vascular fraction) to restore erectile function in men with ED (erectile dysfunction).

开始日期2022-04-01

申办/合作机构

Tissue Genesis LLC

NCT02234778 / Unknown statusN/A

Evaluation of the Use of the Tissue Genesis® Icellator Cell Isolation System™ for Autologous Adipose-Derived Stromal Vascular Fraction Cells to Treat Critical Limb Ischemia

The purpose of this study is to determine the safety and effectiveness of the Tissue Genesis® Icellator Cell Isolation System™ in Critical Limb Ischemia. The Icellator System™ device removes certain cells from the adipose (fat) tissue which will be used to treat patients with blockages in the arteries of their lower legs that may require a future amputation, which is caused by severe peripheral artery disease (PAD). The purpose of this study is to determine if treatment with cells that have been removed from the Icellator System™ device will reduce the number of major amputations and deaths in a six month time period.

开始日期2014-08-01

申办/合作机构

Tissue Genesis LLC

[+1]

NCT01601353 / Unknown statusN/A

Evaluate the Use of Liposuction and Cell Separation Devices for Autologous Fat (Adipose) Derived Cells to Treat the Symptoms of Erectile Dysfunction

The purpose of this study is to evaluate the safety and efficacy of adipose derived cells for the treatment of erectile dysfunction symptoms.

开始日期2012-05-01

申办/合作机构

Tissue Genesis LLC

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0 项与 Tissue Genesis LLC 相关的专利（医药）

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项与 Tissue Genesis LLC 相关的文献（医药）

2020-04-01·Stem cells and development3区 · 医学

Safety of Human Adipose Stromal Vascular Fraction Cells Isolated with a Closed System Device in an Immunocompetent Murine Pressure Ulcer Model

3区 · 医学

Article

作者: Vanek, Mikaela ; Walendzik, Katarzyna ; Gimble, Jeffrey M. ; Katz, Adam J. ; Bukowska, Joanna ; Mehrara, Babak ; Alarcon Uquillas, Andrea ; Frazier, Trivia ; Bunnell, Bruce A. ; Wu, Xiying ; Gawronska-Kozak, Barbara ; Kosnik, Paul ; Gaupp, Dina

Pressure ulcers (PUs) result in part due to ischemia-reperfusion injury to the skin and present frequently in elderly or quadriplegic patients with reduced mobility. Despite the high economic and societal cost of this condition, PU therapy relies primarily on preventive strategies and invasive surgical intervention. A growing body of clinical literature suggests that localized injection of adipose-derived cells can accelerate and enhance the closure of PUs. The current study systematically evaluated the safety of human adipose stromal vascular fraction (SVF) cells isolated using a closed system device when injected into a murine PU injury model. The human SVF cells were characterized by colony-forming unit-fibroblast and differentiation assays before use. Young (2 months) immunocompetent C57BL/6 mice subjected to a magnet-induced ischemia-reperfusion injury were injected subcutaneously with human SVF cells at increasing doses (0.25-2 million cells). The size of the PU was monitored over a 20-day period. Both female and male mice tolerated the concentration-dependent injection of the SVF cells without complications. While male mice trended toward more rapid wound closure rates in response to lower SVF cell concentrations (0.25-0.5 million cells), female mice responded favorably to higher SVF cell concentrations (1-2 million cells); however, outcomes did not reach statistical significance in either sex. Overall, the study demonstrates that human SVF cells prepared with a closed system device designed for use at point of care can be safely administered for PU therapy in an immunocompetent host animal model.

2020-04-01·Stem cells and development3区 · 医学

Safety and Efficacy of Human Adipose-Derived Stromal/Stem Cell Therapy in an Immunocompetent Murine Pressure Ulcer Model

3区 · 医学

Article

作者: Vanek, Mikaela ; Walendzik, Katarzyna ; Gimble, Jeffrey M. ; Katz, Adam J. ; Bukowska, Joanna ; Mehrara, Babak ; Alarcon Uquillas, Andrea ; Frazier, Trivia ; Bunnell, Bruce A. ; Gawronska-Kozak, Barbara ; Kosnik, Paul ; Wu, Xiying ; Gaupp, Dina

Pressure injuries/ulcers are frequent complications in elderly, paraplegic, and quadriplegic patients, which account for considerable cost to the international health care economy and remain refractory to current treatment options. Autologous or allogeneic adult stromal/stem cells represent an alternative therapeutic approach. The current study extends prior findings by exploring the safety and efficacy of human adipose-derived stromal/stem cell (ASC) therapy in an established immunocompetent murine skin pressure ulcer model where dermal fibroblast cells (DFCs) served as a control. Human adipose tissue was processed using a closed system device designed for point-of-care use in the operating room and on file with the Food and Drug Administration. Cell characterization was performed using colony-forming unit-fibroblast, differentiation, and immunophenotypic assays in vitro. Wound healing was assessed over a 20-day period based on photomicrographs, histology, and immunohistochemistry. The isolated human ASCs displayed significantly greater colony formation relative to DFCs while both populations exhibited comparable immunophenotype and differentiation potential. Both fresh and cryopreserved human ASCs significantly accelerated and enhanced wound healing in young (2 month) mice of both sexes relative to DFC controls based on tissue architecture and CD68⁺ cell infiltration. In contrast, while injection of either fresh or cryopreserved human ASCs was safe in older mice, the fresh ASCs significantly enhanced wound closure relative to the cryopreserved ASCs. Overall, these findings support the safety and efficacy of human ASCs isolated using a closed system device designed for clinical procedures in the future treatment of pressure injuries.

2016-04-01·International orthopaedics2区 · 医学

Stromal vascular stem cell treatment decreases muscle fibrosis following chronic rotator cuff tear

2区 · 医学

Article

作者: Roche, Stuart M ; Kosnik, Paul E ; Momoh, Adeyiza O ; Bedi, Asheesh ; Flood, Michael D ; Mendias, Christopher L ; Sugg, Kristoffer B ; Gumucio, Jonathan P

PURPOSE:

Rotator cuff injuries are associated with atrophy and fat infiltration into the muscle, commonly referred to as "fatty degeneration." As the poor function of chronically torn muscles may limit recovery after surgical repair, there is considerable interest in finding therapies to enhance muscle regeneration. Stromal vascular fraction stem cells (SVFCs) can improve muscle regeneration in other chronic injury states, and our objective was to evaluate the ability of SVFCs to reduce fibrosis and fat accumulation, and enhance muscle fibre specific force production after chronic rotator cuff tear.

METHODS:

Chronic supraspinatus tears were induced in adult immunodeficient rats, and repaired one month following tear. Rats received vehicle control, or injections of 3 × 10(5) or 3 × 10(6) human SVFCs into supraspinatus muscles.

RESULTS:

Two weeks following repair, we detected donor human DNA and protein in SVFC treated muscles. There was a 40 % reduction in fibrosis in the treated groups compared to controls (p = 0.03 for 3 × 10(5), p = 0.04 for 3 × 10(6)), and no differences between groups for lipid content or force production were observed.

CONCLUSIONS:

As there has been much interest in the use of stem cell-based therapies in musculoskeletal regenerative medicine, the reduction in fibrosis and trend towards an improvement in single fiber contractility suggest that SVFCs may be beneficial to enhance the treatment and recovery of patients with chronic rotator cuff tears.

项与 Tissue Genesis LLC 相关的新闻（医药）

2021-04-28

·GlobeNewswire

MiMedx Welcomes Dirk Stevens, Ph.D., as Senior Vice President, Quality Assurance and Regulatory Affairs

Accomplished Regulatory Leader Joins MiMedx Management Team MARIETTA, Ga., April 28, 2021 (GLOBE NEWSWIRE) -- MiMedx Group, Inc. (Nasdaq: MDXG) (“MiMedx” or “the Company”), an industry leader in utilizing amniotic tissue as a platform for regenerative medicine, today announced the addition of Dirk Stevens, Ph.D., as Senior Vice President, Quality Assurance and Regulatory Affairs, effective May 3, 2021. Dr. Stevens, who brings more than 35 years of strategic leadership experience in quality management and regulatory compliance across multiple medical device and pharmaceutical companies, joins MiMedx from Smith & Nephew, plc, where he was accountable for regulatory submissions, compliance, and Commercial Quality Assurance. Timothy R. Wright, MiMedx Chief Executive Officer, commented, “Over the past two years, we have assembled a capable and cohesive leadership team with domain and subject-matter expertise, and the addition of Dr. Stevens exemplifies our ongoing commitment to advancing the quality standards for both science and manufacturing in our industry. His extensive operational insight, relevant experience in regulatory review and submission processes, and proficiency in quality systems assurance will be instrumental as we continue to advance our late-stage pipeline under Current Good Manufacturing Practice (CGMP) standards. Each employee at MiMedx is laser-focused on ensuring that our products can safely, effectively, and efficiently reach the patients who need them. We are thrilled to welcome Dr. Stevens to the MiMedx team.” Dr. Stevens remarked, “MiMedx is at the forefront of amniotic tissue biologics at a time when the industry is at an inflection point. I’m eager to be part of this moment and look forward to furthering the organization’s efforts to bring transformative treatment options to the people who need them the most.” About Dirk Stevens, Ph.D. Dirk Stevens, Ph.D. served as Vice President, Global Regulatory Affairs at Smith & Nephew, plc, since April 2019. During his time at Smith & Nephew, Dr. Stevens developed the company’s organizational regulatory strategy, and worked closely with Wound Management Regulatory on Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). Prior to that, Dr. Stevens led Quality Systems and Regulatory Affairs for Fresenius Medical Care, beginning in May 2014. In both roles, he was responsible for developing strategic processes for deliverables management and measurement within regulatory affairs systems. Dr. Stevens has served as a quality and regulatory leader in the Medical Device and Pharmaceutical industries, holding jobs of increasing responsibility at companies such as Johnson & Johnson, Baxter Healthcare, and Covidien. In addition, he was an officer in the U.S. Army, spending 5 years in active military service and another 10 years as a Reservist. Dr. Stevens earned his associate of arts, engineering at New Mexico Military Institute before going on to receive his bachelor of science in civil engineering at the United States Military Academy, West Point, NY. He continued his education at Keller Graduate School of Management, where he received his master’s degree in business administration before earning his Ph.D. at Walden University. Important Information The Company intends to file a definitive proxy statement and associated WHITE proxy card in connection with the solicitation of proxies for the 2021 Annual Meeting with the Securities and Exchange Commission (the “SEC”). Details concerning the nominees of the Company’s board of directors for election at the 2021 Annual Meeting will be included in the proxy statement. BEFORE MAKING ANY VOTING DECISION, SHAREHOLDERS OF THE COMPANY ARE URGED TO READ ALL RELEVANT DOCUMENTS FILED WITH OR FURNISHED TO THE SEC, INCLUDING THE COMPANY’S DEFINITIVE PROXY STATEMENT AND ANY SUPPLEMENTS THERETO, BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION. Investors and shareholders will be able to obtain a copy of the definitive proxy statement and other documents filed by the Company free of charge from the SEC’s website at . The Company’s shareholders will also be able to obtain, without charge, a copy of the definitive proxy statement and other relevant filed documents from the “SEC Filings” section of the Company’s website at . Participants in the Solicitation The Company, its directors, its director nominees and certain of its executive officers are participants in the solicitation of proxies from shareholders in respect of the 2021 Annual Meeting. Information regarding the names of the Company’s directors and executive officers and certain other individuals and their respective interests in the Company by security holdings or otherwise is set forth in the Annual Report on Form 10-K of the Company for the fiscal year ended December 31, 2020, filed with the SEC on March 8, 2021, and the Company’s definitive proxy statement for the 2020 annual meeting of the Company’s shareholders, filed with the SEC on October 15, 2020. To the extent holdings of such participants in the Company’s securities have changed since the amounts described in the proxy statement for the 2020 annual meeting of the Company’s shareholders, such changes have been reflected on Initial Statements of Beneficial Ownership on Form 3 or Statements of Change in Ownership on Form 4 filed with the SEC. Additional information regarding the interests of these participants in any proxy solicitation and a description of their direct and indirect interests, by security holdings or otherwise, will also be included in the Company’s proxy statement and other relevant materials to be filed with the SEC, if and when they become available. Details regarding the nominees of the Company’s Board of Directors for election at the 2021 Annual Meeting will be included in the Company’s proxy statement, when available. About MiMedx MiMedx is an industry leader in utilizing amniotic tissue as a platform for regenerative medicine, developing and distributing placental tissue allografts with patent-protected, proprietary processes for multiple sectors of healthcare. As a pioneer in placental biologics, we have both a core business, focused on addressing the needs of patients with acute and chronic non-healing wounds, and a promising late-stage pipeline targeted at decreasing pain and improving function for patients with degenerative musculoskeletal conditions. We derive our products from human placental tissues and process these tissues using our proprietary methods, including the PURION® process. We employ Current Good Tissue Practices, Current Good Manufacturing Practices, and terminal sterilization to produce our allografts. MiMedx has supplied over two million allografts, through both direct and consignment shipments. For additional information, please visit . Contact: InvestorsJack Howarth404-360-5681investorrelations@mimedx.com

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