预约演示

更新于：2025-10-21

Rexlemestrocel-L

更新于：2025-10-21

概要

概要

基本信息

药物类型

间充质干细胞疗法

别名

Allogeneic mesenchymal precursor cells Mesoblast、Allogeneic STRO3 immunoselected bone marrowderived mesenchymal precursor cells (MPCs) Mesoblast、Mesenchymal stem cell therapy Mesoblast

+ [3]

靶点-

作用方式-

作用机制

细胞替代物

治疗领域

神经系统疾病皮肤和肌肉骨骼疾病其他疾病

在研适应症

椎间盘退化腰痛

非在研适应症

前交叉韧带损伤慢性心力衰竭2型糖尿病+ [9]

原研机构

Institute of Medical & Veterinary Science

在研机构

Mesoblast Ltd.

非在研机构

Teva Pharmaceutical Industries Ltd.

Mesoblast, Inc.

权益机构

Teva Pharmaceutical Industries Ltd.

Mesoblast Ltd.

Cephalon, Inc.

最高研发阶段临床3期

首次获批日期-

最高研发阶段(中国)-

特殊审评孤儿药 (美国)、罕见儿科疾病 (美国)、再生医学先进疗法 (美国)

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关联

项与 Rexlemestrocel-L 相关的临床试验

NCT06325566

/ Recruiting临床3期

A Prospective, Multicenter, Randomized, Double-blind, Controlled Study to Evaluate the Efficacy and Safety of a Single Injection of Rexlemestrocel-L Combined With HA in Subjects With Moderate to Severe Chronic Low Back Pain

The primary purpose of this study is to evaluate the efficacy of rexlemestrocel-L+HA compared to control in reducing low back pain at 12 months post-treatment and safety of a single injection of rexlemestrocel-L+HA injected into a lumbar intervertebral disc compared to control through 12 months post-treatment.

开始日期2024-07-03

申办/合作机构

Mesoblast Ltd.

NCT03079401

/ Unknown status临床1/2期IIT

Mesoblast Stem Cell Therapy for Patients With Single Ventricle and Borderline Left Ventricle

Patients under the age of 5, with a diagnosis of hypoplastic left heart syndrome (HLHS), unbalanced atrioventricular canal (uAVC), or borderline left heart who are undergoing staged LV recruitment following bidirectional Glenn (BDG) or undergoing BDG with plans for LV recruitment will be considered for enrollment in this study. Those patients enrolled in the study will be randomized to either the experimental arm or control arm of the study. Those patients randomized to the experimental arm will receive mesenchymal precursor cells (MPCs) injected directly into the LV endocardium during their LV recruitment or BDG procedure. Those patients randomized to the control arm will receive normal standard of care during their procedure with no injection of MPCs.
It is believed that injection of MPCs will help improve the chances of those patients with single ventricle or borderline left ventricle being converted to biventricular circulation which could improve quality of life and longevity over palliation.

开始日期2017-11-27

申办/合作机构

The Children's Hospital Corp.

NCT02412735

/ Completed临床3期

A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of a Single Injection of Rexlemestrocel-L Alone or Combined With Hyaluronic Acid (HA) in Subjects With Chronic Low Back Pain

This is a prospective, multicenter, randomized, double-blind, placebo-controlled Phase 3 study designed to evaluate the safety and efficacy of Mesoblast's rexlemestrocel-L alone or combined with hyaluronic acid (HA) in participants with chronic low back pain (> 6 months) associated with moderate radiographic degenerative changes of a disc.

开始日期2015-03-06

申办/合作机构

Mesoblast Ltd.

[+1]

100 项与 Rexlemestrocel-L 相关的临床结果

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100 项与 Rexlemestrocel-L 相关的转化医学

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100 项与 Rexlemestrocel-L 相关的专利（医药）

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项与 Rexlemestrocel-L 相关的文献（医药）

2016-10-01·EBioMedicine1区 · 医学

Allogeneic Mesenchymal Precursor Cells (MPC) in Diabetic Nephropathy: A Randomized, Placebo-controlled, Dose Escalation Study

1区 · 医学

ArticleOA

作者: Segal, Karen R ; Fraser, Ian R ; Kerr, Peter G ; Packham, David K

BACKGROUND:

Diabetic nephropathy is the most common cause of end stage renal failure. We assessed the safety, tolerability, and explored therapeutic effects of adult allogeneic bone-marrow derived mesenchymal precursor cells (MPC) in patients with moderate to severe diabetic nephropathy.

METHODS:

Multicenter, randomized, double-blind, dose-escalating, sequential, placebo-controlled trial assessing a single intravenous (IV) infusion of allogeneic MPC (United States adopted name: rexlemestrocel-L) 150×10⁶ (n=10), 300×10⁶ (n=10) or placebo (n=10) in adults with diabetic nephropathy with an estimated glomerular filtration rate (eGFR) 20-50ml/min/1.73m². Thirty patients at three Australian centers were enrolled between July 2013 and June 2014 and randomized 2:1, in two sequential dose cohorts, to receive rexlemestrocel-L or placebo. Study duration was 60weeks. Primary endpoint was safety and tolerability. Primary exploratory efficacy endpoint was change from baseline in eGFR and directly measured GFR by ⁹⁹Tc-DTPA plasma clearance (mGFR) at 12weeks post-infusion. The trial was registered on ClinicalTrials.gov (NCT01843387).

FINDINGS:

All patients completed the study and were included in analyses applied to the intention to treat population. There were no acute adverse events (AEs) associated with infusion and no treatment-related AEs or serious AEs were deemed treatment-related by investigators. No patients developed persistent donor specific anti-HLA antibodies. Relative to placebo, a single IV rexlemestrocel-L infusion showed trends of stabilizing or improving eGFR and mGFR at week 12. The adjusted least squares mean (LSM±SE) differences from placebo in changes from baseline at 12weeks in the rexlemestrocel-L groups were 4.4±2.16 and 1.6±2.15ml/min/1.73m² for eGFR and 4.1±2.75 and 3.9±2.75 for mGFR for the 150×10⁶ and 300×10⁶ cell groups, respectively.

INTERPRETATION:

This study demonstrates the safety of rexlemestrocel-L in diabetic nephropathy with suggestive effects on renal function to be confirmed in larger, appropriately powered trials.

2015-09-01·Diabetes care1区 · 医学

Allogeneic Mesenchymal Precursor Cells in Type 2 Diabetes: A Randomized, Placebo-Controlled, Dose-Escalation Safety and Tolerability Pilot Study

1区 · 医学

Article

作者: Segal, Karen R. ; Fonseca, Vivian A. ; Skyler, Jay S. ; Rosenstock, Julio

OBJECTIVE:

To assess the safety, tolerability, and feasibility of adult allogeneic bone marrow–derived mesenchymal precursor cells (MPCs) in type 2 diabetes inadequately controlled with metformin either alone or with one additional oral antidiabetic agent.

RESEARCH DESIGN AND METHODS:

The study was a dose-escalating randomized placebo-controlled trial assessing one intravenous (IV) infusion of MPCs (rexlemestrocel-L; Mesoblast Inc.) 0.3 × 106/kg (n = 15), 1.0 × 106/kg (n = 15), or 2.0 × 106/kg (n = 15) or placebo (n = 16). Study duration was 12 weeks.

RESULTS:

Subjects (21 women, 40 men) with a mean ± SD baseline HbA1c 8.3 ± 1.0% (67 ± 10.9 mmol/mol), BMI 33.5 ± 5.5 kg/m2, and diabetes duration 10.1 ± 6.0 years were enrolled at 18 U.S. sites. No acute adverse events (AEs) were associated with infusion. No serious AEs, serious hypoglycemia AEs, or discontinuations due to AEs over 12 weeks were found. No subjects developed donor-specific anti-HLA antibodies or became sensitized. The safety profile was comparable among treatment groups. Compared with placebo, a single IV infusion of rexlemestrocel-L reduced HbA1c at all time points after week 1. The adjusted least squares mean ± SE dose-related differences in HbA1c from placebo in the rexlemestrocel-L groups ranged from −0.1 ± 0.2% (−1.1 ± 2.2 mmol/mol) to −0.4 ± 0.2% (4.4 ± 2.2 mmol/mol) at 8 weeks and from 0.0 ± 0.25% to −0.3 ± 0.25% (−3.3 ± −2.7 mmol/mol) at 12 weeks (P < 0.05 for 2.0 × 106/kg dose at 8 weeks). The clinical target HbA1c <7% (53 mmol/mol) was achieved by 33% (5 of 15) of the subjects who received the 2.0 × 106/kg dose vs. 0% of those who received placebo (P < 0.05).

CONCLUSIONS:

This short-term study demonstrates the safety and feasibility of up to 246 million MPCs in subjects with type 2 diabetes.

EUROPEAN JOURNAL OF HEART FAILURE

Mesenchymal precursor cells reduce mortality and major morbidity in ischaemic heart failure with inflammation: DREAM‐HF

Article

作者: Rose, Eric ; James, Christopher W. ; Perin, Emerson C. ; Greenberg, Barry ; Rutman, Olga ; Itescu, Silviu ; Henry, Timothy D. ; Hayes, Jack ; Skali, Hicham ; Borow, Kenneth M. ; Jenkins, Margaret

Aims:

Progressive heart failure with reduced ejection fraction (HFrEF) is adversely affected by alterations in the myocardial balance between bone marrow‐derived pro‐inflammatory cardiac macrophages and embryo‐derived reparative cardiac resident macrophages. Mesenchymal precursor cells (MPCs) may restore this balance and improve clinical outcomes when inflammation is present. The purpose was to (i) identify risk factors for cardiovascular death (CVD) in control patients with HFrEF in the DREAM‐HF trial, and (ii) determine if MPCs improve major clinical outcomes (CVD, myocardial infarction [MI], stroke) in high‐risk patients with ischaemic HFrEF and inflammation.

Methods and results:

Cause‐specific regression analyses were used to identify CVD risk factors in DREAM‐HF control patients. Aalen–Johansen cumulative incidence curves were used to examine CVD, 2‐point major adverse cardiovascular events (MACE) (MI or stroke), and 3‐point MACE (CVD or MI or stroke) by treatment group in ischaemic vs non‐ischaemic HFrEF and in patients with or without baseline inflammation. In control DREAM‐HF patients, factors portending the greatest risk for CVD were inflammation (baseline plasma high‐sensitivity C‐reactive protein ≥2 mg/L; p = 0.003) and ischaemic HFrEF aetiology (p = 0.097), with increased CVD risk of 61% and 38%, respectively. Over 30‐month mean follow‐up, MPCs reduced 2‐point and 3‐point MACE by 88% (p = 0.005) and 52% (p = 0.018), respectively, in patients with ischaemic HFrEF and inflammation compared to controls.

Conclusion:

Ischaemic aetiology and inflammation were identified as major risk factors for MACE in control DREAM‐HF patients. A single intramyocardial MPC administration produced the most significant, sustained reduction in 2‐point and 3‐point MACE in patients with ischaemic HFrEF and inflammation.

106

项与 Rexlemestrocel-L 相关的新闻（医药）

2025-10-03

·GlobeNewswire-Health Care

Ryoncil® Receives J-Code From Medicare & Medicaid Services (CMS) Facilitating Reimbursement and Broader Patient Access

NEW YORK, Oct. 02, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that a specific Healthcare Common Procedure Coding System (HCPCS) J-Code assigned to Ryoncil® (remestemcel-L-rknd) by United States Medicare & Medicaid Services (CMS) became active for billing and reimbursement on October 1, 2025.1 Formal recognition by CMS is a significant milestone for Ryoncil® as the product becomes easier to bill and pay for. The new permanent J-Code, J3402, provides a standardized, clear, permanent, and specific billing pathway for Ryoncil® by Medicaid, facilitating reimbursement and broader patient access for this important therapy. Additionally, commercial payers look to the permanent J-code to update their coverage systems. Ryoncil® is the first mesenchymal stromal cell (MSC) product approved by the U.S. Food and Drug Administration (FDA) for any indication, and the only product approved for children under age 12 with steroid-refractory acute graft-versus-host disease (SR-aGvHD).2 Mesoblast Chief Executive Dr. Silviu Itescu said: “A permanent J-Code is a critical element for successful commercialization of rare disease products, ensuring more efficient billing and enabling timely access to Ryoncil® for children with life-threatening SR-aGvHD.” Healthcare providers can begin using J3402 for claims submitted on or after October 1, 2025. For detailed coding and billing guidance, providers are encouraged to consult ryoncil.com.3 About Mesoblast Mesoblast (the Company) is a world leader in developing allogeneic (off-the-shelf) cellular medicines for the treatment of severe and life-threatening inflammatory conditions. The therapies from the Company’s proprietary mesenchymal lineage cell therapy technology platform respond to severe inflammation by releasing anti-inflammatory factors that counter and modulate multiple effector arms of the immune system, resulting in significant reduction of the damaging inflammatory process. Mesoblast’s Ryoncil® (remestemcel-L-rknd) for the treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients 2 months and older is the first FDA-approved mesenchymal stromal cell (MSC) therapy. Please see the full Prescribing Information at www.ryoncil.com. Mesoblast is committed to developing additional cell therapies for distinct indications based on its remestemcel-L and rexlemestrocel-L allogeneic stromal cell technology platforms. Ryoncil® is being developed for additional inflammatory diseases including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease. Rexlemestrocel-L is being developed for heart failure and chronic low back pain. The Company has established commercial partnerships in Japan, Europe and China. About Mesoblast intellectual property: Mesoblast has a strong and extensive global intellectual property portfolio, with over 1,000 granted patents or patent applications covering mesenchymal stromal cell compositions of matter, methods of manufacturing and indications. These granted patents and patent applications are expected to provide commercial protection extending through to at least 2041 in major markets. About Mesoblast manufacturing: The Company’s proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide. Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter: @Mesoblast References / Footnotes https://www.cms.gov/files/document/r13425cp.pdfPlease see the full Prescribing Information at www.ryoncil.com.Coding and coverage decisions are made by payers, and coverage cannot be guaranteed. Forward-Looking StatementsThis press release includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward-looking statements include, but are not limited to, statements about: the initiation, timing, progress and results of Mesoblast’s preclinical and clinical studies, and Mesoblast’s research and development programs; Mesoblast’s ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; Mesoblast’s ability to advance its manufacturing capabilities; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities, if any; the commercialization of Mesoblast’s RYONCIL for pediatric SR-aGVHD and any other product candidates, if approved; regulatory or public perceptions and market acceptance surrounding the use of stem-cell based therapies; the potential for Mesoblast’s product candidates, if any are approved, to be withdrawn from the market due to patient adverse events or deaths; the potential benefits of strategic collaboration agreements and Mesoblast’s ability to enter into and maintain established strategic collaborations; Mesoblast’s ability to establish and maintain intellectual property on its product candidates and Mesoblast’s ability to successfully defend these in cases of alleged infringement; the scope of protection Mesoblast is able to establish and maintain for intellectual property rights covering its product candidates and technology; estimates of Mesoblast’s expenses, future revenues, capital requirements and its needs for additional financing; Mesoblast’s financial performance; developments relating to Mesoblast’s competitors and industry; and the pricing and reimbursement of Mesoblast’s product candidates, if approved. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblast’s actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise. Release authorized by the Chief Executive. For more information, please contact: Corporate Communications / Investors Paul Hughes T: +61 3 9639 6036 Media – Global Allison Worldwide Emma Neal T: +1 603 545 4843 E: emma.neal@allisonworldwide.com Media – Australia BlueDot Media Steve Dabkowski T: +61 419 880 486 E: steve@bluedot.net.au

细胞疗法上市批准免疫疗法临床研究

2025-09-26

·GlobeNewswire-Health Care

Mesoblast Cell Therapy Products are Designated U.S. Origin and Not Subject to Tariffs

NEW YORK, Sept. 26, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today reiterated that its allogeneic cell therapy products are manufactured from U.S. donors in the U.S. and designated as U.S. origin products not subject to tariffs on imported branded or patented pharmaceutical products. Ryoncil® (remestemcel-L) is the only allogeneic mesenchymal stromal cell therapy approved by U.S. Food and Drug Administration (FDA) for any indication. As documented in the Company’s Biologic License Application (BLA), Ryoncil® is designated a ‘U.S. Country of Origin’ product in line with U.S. FDA and Customs regulatory guidance. Ryoncil® is approved for treatment of pediatric patients 2 months and older, including adolescents and teenagers, with steroid-refractory acute graft versus host disease (SR-aGvHD), a condition with high mortality rates. Mesoblast continues to ensure that all its products, whether for SR-aGvHD, chronic heart failure, chronic back pain, or other inflammatory indications, are manufactured from U.S. donors at U.S. sites. About Mesoblast Mesoblast (the Company) is a world leader in developing allogeneic (off-the-shelf) cellular medicines for the treatment of severe and life-threatening inflammatory conditions. The therapies from the Company’s proprietary mesenchymal lineage cell therapy technology platform respond to severe inflammation by releasing anti-inflammatory factors that counter and modulate multiple effector arms of the immune system, resulting in significant reduction of the damaging inflammatory process. Mesoblast’s Ryoncil® (remestemcel-L-rknd) for the treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients 2 months and older is the first FDA-approved mesenchymal stromal cell (MSC) therapy. Please see the full Prescribing Information at www.ryoncil.com. Mesoblast is committed to developing additional cell therapies for distinct indications based on its remestemcel-L and rexlemestrocel-L allogeneic stromal cell technology platforms. Ryoncil® is being developed for additional inflammatory diseases including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease. Rexlemestrocel-L is being developed for heart failure and chronic low back pain. The Company has established commercial partnerships in Japan, Europe and China. About Mesoblast intellectual property: Mesoblast has a strong and extensive global intellectual property portfolio, with over 1,000 granted patents or patent applications covering mesenchymal stromal cell compositions of matter, methods of manufacturing and indications. These granted patents and patent applications are expected to provide commercial protection extending through to at least 2041 in major markets. About Mesoblast manufacturing: The Company’s proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide. Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter: @Mesoblast Forward-Looking StatementsThis press release includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward-looking statements include, but are not limited to, statements about: the initiation, timing, progress and results of Mesoblast’s preclinical and clinical studies, and Mesoblast’s research and development programs; Mesoblast’s ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; Mesoblast’s ability to advance its manufacturing capabilities; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities, if any; the commercialization of Mesoblast’s Ryoncil® for pediatric SR-aGVHD and any other product candidates, if approved; regulatory or public perceptions and market acceptance surrounding the use of stem-cell based therapies; the potential for Mesoblast’s product candidates, if any are approved, to be withdrawn from the market due to patient adverse events or deaths; the potential benefits of strategic collaboration agreements and Mesoblast’s ability to enter into and maintain established strategic collaborations; Mesoblast’s ability to establish and maintain intellectual property on its product candidates and Mesoblast’s ability to successfully defend these in cases of alleged infringement; the scope of protection Mesoblast is able to establish and maintain for intellectual property rights covering its product candidates and technology; estimates of Mesoblast’s expenses, future revenues, capital requirements and its needs for additional financing; Mesoblast’s financial performance; developments relating to Mesoblast’s competitors and industry; and the pricing and reimbursement of Mesoblast’s product candidates, if approved. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblast’s actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise. Release authorized by the Chief Executive. For more information, please contact: Corporate Communications / Investors Paul Hughes T: +61 3 9639 6036 Media – Global Allison Worldwide Emma Neal T: +1 603 545 4843 E: emma.neal@allisonworldwide.com Media – Australia BlueDot Media Steve Dabkowski T: +61 419 880 486 E: steve@bluedot.net.au

细胞疗法上市批准免疫疗法临床研究

2025-09-15

·GlobeNewswire-Health Care

Successful Commercial Launch of Ryoncil® Highlighted at Global Healthcare Conferences

NEW YORK, Sept. 14, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, announced that the successful commercial launch of Ryoncil® (remestemcel-L-rknd), the only mesenchymal stromal cell (MSC) product approved by the United States Food and Drug Administration (FDA), was highlighted this past week in presentations at the Morgan Stanley and Cantor Fitzgerald Annual Global Healthcare Conferences held in New York. Mesoblast Chief Executive Silviu Itescu reiterated the strong first quarter launch of Ryoncil® and product sales in the treatment of children with steroid-refractory acute graft versus host disease (SR-aGvHD) as recently reported in the Company’s full year earnings and discussed the continued drive to onboard new sites and increase product usage. Dr. Itescu additionally highlighted plans for expanding Ryoncil® into additional indications including adult SR-aGvHD and inflammatory bowel disease (IBD), as well as key Phase 3 milestones for its second-generation product Rexlemestrocel-L. About Mesoblast Mesoblast (the Company) is a world leader in developing allogeneic (off-the-shelf) cellular medicines for the treatment of severe and life-threatening inflammatory conditions. The therapies from the Company’s proprietary mesenchymal lineage cell therapy technology platform respond to severe inflammation by releasing anti-inflammatory factors that counter and modulate multiple effector arms of the immune system, resulting in significant reduction of the damaging inflammatory process. Mesoblast’s Ryoncil® (remestemcel-L-rknd) for the treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients 2 months and older is the first FDA-approved mesenchymal stromal cell (MSC) therapy. Please see the full Prescribing Information at www.ryoncil.com. Mesoblast is committed to developing additional cell therapies for distinct indications based on its remestemcel-L and rexlemestrocel-L allogeneic stromal cell technology platforms. Ryoncil® is being developed for additional inflammatory diseases including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease. Rexlemestrocel-L is being developed for heart failure and chronic low back pain. The Company has established commercial partnerships in Japan, Europe and China. About Mesoblast intellectual property: Mesoblast has a strong and extensive global intellectual property portfolio, with over 1,000 granted patents or patent applications covering mesenchymal stromal cell compositions of matter, methods of manufacturing and indications. These granted patents and patent applications are expected to provide commercial protection extending through to at least 2041 in major markets. About Mesoblast manufacturing: The Company’s proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide. Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter: @Mesoblast Forward-Looking StatementsThis press release includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward-looking statements include, but are not limited to, statements about: the initiation, timing, progress and results of Mesoblast’s preclinical and clinical studies, and Mesoblast’s research and development programs; Mesoblast’s ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; Mesoblast’s ability to advance its manufacturing capabilities; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities, if any; the commercialization of Mesoblast’s Ryoncil® for pediatric SR-aGVHD and any other product candidates, if approved; regulatory or public perceptions and market acceptance surrounding the use of stem-cell based therapies; the potential for Mesoblast’s product candidates, if any are approved, to be withdrawn from the market due to patient adverse events or deaths; the potential benefits of strategic collaboration agreements and Mesoblast’s ability to enter into and maintain established strategic collaborations; Mesoblast’s ability to establish and maintain intellectual property on its product candidates and Mesoblast’s ability to successfully defend these in cases of alleged infringement; the scope of protection Mesoblast is able to establish and maintain for intellectual property rights covering its product candidates and technology; estimates of Mesoblast’s expenses, future revenues, capital requirements and its needs for additional financing; Mesoblast’s financial performance; developments relating to Mesoblast’s competitors and industry; and the pricing and reimbursement of Mesoblast’s product candidates, if approved. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblast’s actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise. Release authorized by the Chief Executive. For more information, please contact: Corporate Communications / InvestorsPaul HughesT: +61 3 9639 6036 Media – Global Allison WorldwideEmma NealT: +1 603 545 4843E: emma.neal@allisonworldwide.com Media – AustraliaBlueDot MediaSteve DabkowskiT: +61 419 880 486E: steve@bluedot.net.au

细胞疗法上市批准临床3期免疫疗法临床结果

100 项与 Rexlemestrocel-L 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
椎间盘退化	临床3期	美国	Mesoblast Ltd.	2015-03-06
椎间盘退化	临床3期	澳大利亚	Mesoblast Ltd.	2015-03-06
腰痛	临床3期	美国	Mesoblast Ltd.	2015-03-06
腰痛	临床3期	澳大利亚	Mesoblast Ltd.	2015-03-06
慢性心力衰竭	临床3期	美国	Mesoblast, Inc.	2014-02-14
慢性心力衰竭	临床3期	加拿大	Mesoblast, Inc.	2014-02-14
心脏衰竭	临床3期	美国	Teva Pharmaceutical Industries Ltd.	2014-01-21
糖尿病肾病	临床2期	澳大利亚	Mesoblast Ltd.	2013-07-01
类风湿关节炎	临床2期	美国	Mesoblast Ltd.	2013-04-26
2型糖尿病	临床2期	美国	Mesoblast Ltd.	2012-04-01

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


Literature 人工标引	N/A	心脏衰竭	-	Mesenchymal precursor cells	網選製艱蓋窪觸遞觸醖(範壓願網夢憲構繭鹽襯): Difference (%) = -88, P-Value = 0.005 更多	积极	2024-11-26
				Comparator
NCT03079401 (Literature) 人工标引	临床1/2期	左心发育不全综合征	19	rexlemestrocel-L	醖醖憲鏇顧艱衊觸膚廠(築鑰膚餘鬱鬱醖製願壓) = Baseline PRA levels were high, with no difference between the groups at 12 months. 網網觸餘餘顧鑰鬱願築 (簾製襯築願膚鏇選鹽觸 )	积极	2023-10-01
				No Intervention
NCT02032004 (DREAM HF-1, GlobeNewswire) 人工标引	临床3期	心脏衰竭	565	Rexlemestrocel-L	繭憲積網鑰壓糧淵鑰淵(積遞鹽範餘鏇窪網膚窪): HR = 1.17 (95% CI, 0.81 ~ 1.69), P-Value = 0.406 更多	不佳	2023-02-27
				Sham Comparator
NCT02412735 (MSB-DR003, CTgov)	临床3期	椎间盘退化 \| 腰痛	404	Rexlemestrocel-L (Rexlemestrocel-L)	繭積憲構願襯鏇築網壓(鹽願齋襯蓋鑰衊鹽糧齋) = 築鹽簾積觸積膚積觸壓膚願蓋膚願鏇餘範窪鑰 (範襯範襯夢鹽範廠獵艱, 0.038) 更多	-	2022-01-18
				HA+Rexlemestrocel-L (Rexlemestrocel-L + HA)	繭積憲構願襯鏇築網壓(鹽願齋襯蓋鑰衊鹽糧齋) = 艱夢蓋淵選窪積繭襯製膚願蓋膚願鏇餘範窪鑰 (範襯範襯夢鹽範廠獵艱, 0.043) 更多
NCT02032004 (DREAM-HF, GlobeNewswire) 人工标引	临床3期	心脏衰竭	537	rexlemestrocel-L	遞衊夢糧壓選遞鏇齋鑰(遞艱選製選選觸醖淵繭) = 鑰艱鏇鏇鹽襯範艱窪衊窪廠壓鏇夢範鏇遞積餘 (願鏇築顧齋鏇壓廠選餘 ) 更多	积极	2020-12-14
				Sham	-