A Single Arm, Open Label, Dose-escalation Phase I and Dose-expansion Phase IIa Clinical Study to Evaluate the Feasibility, Safety, and Efficacy of Allogeneic Chimeric Antigen Receptor (CAR) Gamma-Delta T Cells CAR001 in Subjects With Relapsed/Refractory Solid Tumors

This study is composed of phase I and IIa parts. The dose-escalation phase I part aims to find the maximum tolerated dose (MTD) and to identify the safety of CAR001 in subjects with relapsed/refractory solid tumor; the dose-expansion phase IIa part aims to evaluate the potential efficacy of CAR001 in subjects with relapsed/refractory non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), colorectal cancer (CRC) or Glioblastoma multiforme (GBM).

开始日期2024-04-30

申办/合作机构

长圣国际生技股份有限公司

NCT06147986 / Recruiting临床2期

A Phase IIa, Dose-Escalation Followed by Randomized, Open-Label, Parallel-Group Study to Evaluate the Efficacy and Safety of Allogeneic Umbilical Cord Mesenchymal Stem Cells As an Add-On Treatment for Acute ST-elevation Myocardial Infarction (STEMI) Patients

This phase IIa study is to identify the efficacy and safety of IC(intracoronary) and IV(Intravenous) administrations of UMSC01 in patients with STEMI . This product is a new cell therapy product for treating AMI and produced by Ever Supreme Bio Technology Co., Ltd in Taiwan. The previous Phase I, open-label, single arm, single center study was conducted to evaluate the safety and to explore the efficacy of UMSC01 in subjects with STEMI via intracoronary administration followed by intravenous infusion. This first-in-human Phase I study of UMSC01 was completed on August 2nd, 2021. Among 8 subjects enrolled, no subjects experienced treatment-related TEAEs.

开始日期2023-09-24

申办/合作机构

长圣国际生技股份有限公司

NCT05532943 / Recruiting临床1/2期

A Seamless Phase I/IIa Clinical Study to Evaluate the Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells in Patients With Multiple Sclerosis

This study is to identify the safety and efficacy of repeat IV(Intravenous) and IT(Intrathecal) administrations of UMSC01 in patients with MS. While anti-inflammatory drugs are routinely used for the treatment of MS by inhibiting immune responses, their effects on axon remyelination or neuroregeneration are limited. The combined systemic delivery of UCMSCs via intravenous injection and local administration of the cells by IT was to have safety and therapeutic efficacy for patients with MS.

开始日期2023-09-08

申办/合作机构

长圣国际生技股份有限公司

100 项与长圣国际生技股份有限公司相关的临床结果

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0 项与长圣国际生技股份有限公司相关的专利（医药）

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项与长圣国际生技股份有限公司相关的文献（医药）

Frontiers in cardiovascular medicine

First-in-human pilot trial of combined intracoronary and intravenous mesenchymal stem cell therapy in acute myocardial infarction

Article

作者: Lin, Yen-Nien ; Chang, Shih-Sheng ; Cho, Der-Yang ; Chiu, Lu-Ting ; Tseng, Wen-Yih I ; Chang, Kuan-Cheng ; Lu, Chiung-Ray ; Lin, Yu-Kai ; Chen, Chien-Lin ; Hsu, Chin-Ting ; Lin, Cheng-Li ; Tsai, Cheng-Kang ; Hsiao, Lien-Cheng ; Shyu, Woei-Cherng ; Su, Mao-Yuan ; Hu, Kai-Chieh ; Chen, Jan-Yow ; Wu, Mei-Yao ; Tsai, Chang-Hai ; Wang, Yu-Chen ; Li, Keng-Yuan ; Jeng, Long-Bin ; Ho, Ming ; Lu, Shang-Yeh

Background:

Acute ST-elevation myocardial infarction (STEMI) elicits a robust cardiomyocyte death and inflammatory responses despite timely revascularization.

Objectives:

This phase 1, open-label, single-arm, first-in-human study aimed to assess the safety and efficacy of combined intracoronary (IC) and intravenous (IV) transplantation of umbilical cord-derived mesenchymal stem cells (UMSC01) for heart repair in STEMI patients with impaired left ventricular ejection fraction (LVEF 30-49%) following successful reperfusion by percutaneous coronary intervention.

Methods:

Consenting patients received the first dose of UMSC01 through IC injection 4-5 days after STEMI followed by the second dose of UMSC01 via IV infusion 2 days later. The primary endpoint was occurrence of any treatment-related adverse events and the secondary endpoint was changes of serum biomarkers and heart function by cardiac magnetic resonance imaging during a 12-month follow-up period.

Results:

Eight patients gave informed consents, of whom six completed the study. None of the subjects experienced treatment-related serious adverse events or major adverse cardiovascular events during IC or IV infusion of UMSC01 and during the follow-up period. The NT-proBNP level decreased (1362 ± 1801 vs. 109 ± 115 pg/mL, p = 0.0313), the LVEF increased (52.67 ± 12.75% vs. 62.47 ± 17.35%, p = 0.0246), and the wall motion score decreased (26.33 ± 5.57 vs. 22.33 ± 5.85, p = 0.0180) at the 12-month follow-up compared to the baseline values. The serial changes of LVEF were 0.67 ± 3.98, 8.09 ± 6.18, 9.04 ± 10.91, and 9.80 ± 7.56 at 1, 3, 6, and 12 months, respectively as compared to the baseline.

Conclusion:

This pilot study shows that combined IC and IV transplantation of UMSC01 in STEMI patients with impaired LVEF appears to be safe, feasible, and potentially beneficial in improving heart function. Further phase 2 studies are required to explore the effectiveness of dual-route transplantation of UMSC01 in STEMI patients.

项与长圣国际生技股份有限公司相关的新闻（医药）

2024-01-10

·PRNewswire

Global Cord Blood and Tissue Banking Industry Gains Traction Amidst Surging M&A Activity and Technological Advances

DUBLIN, Jan. 10, 2024 /PRNewswire/ -- The "Global Cord Blood & Tissue Banking Industry Report - Market Size, Segmentation, & Forecasts, 2024" report has been added to ResearchAndMarkets.com's offering. Industry Analysis Unveils Consolidation Dynamics and Regional Market Expansion The global cord blood and tissue banking industry is undergoing a period of significant transformation characterized by robust merger and acquisition activities, technological innovation, and market expansion. A new research publication delves into the intricacies of this dynamic market, offering in-depth insights into current trends, future projections, and strategic developments through 2030. Amidst the spotlight on the healthcare sector for tailored and advanced therapeutic solutions, cord blood and tissue banking has emerged as a pivotal component. Cord blood, known for its potent hematopoietic stem cells, has a track record of over 40,000 transplants worldwide, heralding a new era in treatment options for a myriad of diseases. This comprehensive analysis not only highlights the milestones achieved in cord blood and tissue transplants but also sheds light on the storage capabilities of both public and private banks worldwide. Strategic Developments and Market Segmentation Public and private cord blood banks' cryopreservation units Global utilization of cord blood cells in regenerative medicine Emerging technologies enhancing public banks' financial sustainability Expansion services in the realm of cord blood banking Highlighting the geographical market expanse, the report underscores India's and China's dominant positions, collectively housing over a third of the world's population. Such demographics present vast opportunities for cord blood and tissue banking services. LifeCell International's commanding presence in India, managing over 320,000 stem cell units, exemplifies the regional market's potential. The U.S landscape has not been left behind in the wave of industry consolidation, with major players like CooperSurgical and Cryoholdco cementing their status through strategic acquisitions. With a focus on enhancing comprehensive cord blood banking services, the industry is witnessing expanded offerings that include reproductive services, genetic testing, and cell therapy product development. Furthermore, the report identifies the burgeoning market segments within the cord blood and tissue banking sphere, from storage market revenues and the therapeutic use of cord blood in transplantation medicine to the cutting-edge arena of regenerative medicine applications. Celebrating Scientific Progress and Market Evolution In a market ripe with scientific innovation, such as the groundbreaking FDA approval of Omisirge for recuperating cancer patients' white blood cells, the industry's potential is unmistakable. Moreover, the diverse application in clinical trials, with over 1,200 studies, illustrates the industry's pivotal role in advancing healthcare. The strategic report is an indispensable resource for stakeholders looking to navigate the complexities of the cord blood and tissue banking industry. It stands as a testament to the ongoing metamorphosis of this niche yet essential healthcare service, offering a horizon of opportunities for market participants and recipients alike. Advocating for informed decision-making and strategic positioning within the healthcare sector, this publication is an authoritative guide that equips entities with the knowledge to leverage the unfolding trends and optimize their operational footprint in the cord blood and tissue banking markets. As the industry continues to evolve, the insights from this report pave the way for informed dialogue, strategic planning, and competitive positioning within the global cord blood and tissue banking landscape. The report presents findings on the following topics: Number of cord blood and tissue units cryopreserved in public and private cord blood banks worldwide Number of hematopoietic stem cell transplants (HSCTs) performed globally using cord blood cells Utilization of cord blood cells in regenerative medicine clinical trials The decline of the utilization of cord blood cells in HSCT since 2005 Emerging technologies that will influence the financial sustainability of public cord blood banks The future scope for companion products derived from cord blood The changing landscape of the cord blood and tissue banking market Expansion and extension of services by cord blood banks Types of cord blood banks Economic model of public cord blood banks Cost analysis for public cord blood banks Economic model of private cord blood banks Cost analysis for private cord blood banks Profit margins for private cord blood banks Pricing for processing and storage in private banks Rate per cord blood unit in the U.S. and Europe Indications for the use of cord blood-derived HSCs within transplantation medicine Diseases targeted by cord blood-derived MSCs in regenerative medicine Cord blood processing technologies Number of clinical trials, number of published scientific papers, and amount of NIH funding for cord blood research Number and types of patents for cord blood, cord tissue, and placental products Transplantation data from different cord blood registries Companies Mentioned AllCells AlphaCord Americord Registry, Inc. Angiocrine Bioscience Anja Health Personalized Cord Blood Banking Anthony Nolan Baylx, Inc. Be The Match Biocell Center BioEden BioIntegrate, LLC Bloodworks Northwest California Umbilical Cord Collection Program Carolinas Cord Blood Bank (CCBB) Celaid Therapeutics Celebration Stem Cell Centre (CSCC) Cell Care Cellenkos, Inc. Cells4Life Group LLP CellSave Arabia Celularity, Inc. Center for International Blood and Marrow Transplant Research (CIBMTR) CHOC Blood Bank Cleveland Cord Blood Center ClinImmune Cell and Gene Therapy CooperSurgical Cord Blood Bank of Arkansas (CBBA) Cord Blood Center Group Cord Blood Registry (owned by CooperSurgical) Cord for Life CordLife Group, Ltd. CordVida Crioestaminal Cryo-Cell International, Inc. CryoCyte, LLC Cryoholdco Cryolife Cryopoint Cryoviva Biotech Pvt., Ltd. DentCell DKMS gGMBH Duke University School of Medicine European Society for Blood and Bone Marrow Transplantation (EBMT) Ever Supreme Bio Technology, Co., Ltd. ExCellThera FamiCord Group Fate Therapeutics, Inc. Future Health Gamida Cell GeneCell Global Cord Blood Corporation (GCBC) Glycostem Therapeutics Hawaii Cord Blood Bank HealthBaby HealthBanks Biotech Company Ltd. HealthBanksUSA HEMAFUND Hemogenyx Pharmaceuticals IMMUNIQUE Insception LifeBank JP McCarthy Cord Stem Cell Bank Kangstem Biotech, Co., Ltd. Life Line Stem Cell LifebankUSA LifeCell International Pvt. Ltd. LifeSouth Cord Blood Bank Magenta Therapeutics Maze Cord Blood MD Anderson Cord Blood Bank Medipost, Co., Ltd. Mesoblast, Ltd. MiracleCord, Inc. Mononuclear Therapeutics, Ltd. New England Cord Blood Bank, Inc. New York Blood Center OrganaBio PacifiCord PBKM FamiCord Plasticell Ltd. ReeLabs Pvt. Ltd. Restem, LLC San Diego Cord Blood Bank Saneron CCEL Therapeutics, Inc. Sanpower Group SmartCells SSM Cardinal Glennon Children's Medical Center Stem Cell Cryobank, Inc. Stembanc, Inc. StemCyte, Inc. Throne Biotechnologies, Inc. Transcell Biolife Upstate Cord Blood Bank VCANBIO Cell & Gene Engineering Corporation Versity, Inc. ViaCord Vita 34 AG Vitalant Clinical Services World Marrow Donor Association (WMDA) Worldwide Network for Blood & Marrow Transplantation (WBMT) For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

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