Delving into the Latest Updates on Amimestrocel with Synapse

Overview

Basic Info

Drug Type

Mesenchymal stem cell therapy

Synonyms

Human cord derived MSC cell(Platinum Life Excellence Biotech), 人脐带间充质干细胞（铂生卓越生物科技）

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Target-

Mechanism

Stem cell replacements

Therapeutic Areas

Immune System DiseasesOther DiseasesRespiratory Diseases

Active Indication

Acute Graft Versus Host DiseaseIdiopathic Pulmonary Fibrosis

Inactive Indication-

Originator Organization

Bosheng Excellence Biotechnology (Beijing) Co., Ltd.

Active Organization

Bosheng Excellence Biotechnology (Beijing) Co., Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

CN (02 Jan 2025),

Acute Graft Versus Host Disease

RegulationConditional marketing approval (CN), Priority Review (CN)

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BACKGROUNDSystemic corticosteroid therapy failure is quite common in patients with newly diagnosed acute graft-versus-host disease (aGVHD). Growing evidence has suggested that mesenchymal stem cell (MSC) therapy could be a promising treatment option for aGVHD due to its distinctive immunomodulating functions. However, there is a lack of randomized well-controlled clinical trials.METHODSThis is a clinical trial protocol for a multicenter, randomized, double-blind, placebo-controlled phase II study. The aim of the trial is to evaluate the efficacy and safety of the administration of the human umbilical cord-derived MSC product hUC-MSC PLEB001 in patients with grade II-IV, steroid-refractory aGVHD. A total of 96 patients will be randomized 1:1 to receive MSC or placebo treatment twice per week for 4 weeks, in addition to second-line therapy according to institutional standards. Patients who achieve partial response (PR) at day 28 will be eligible to receive further infusions twice per week for an additional 4 weeks.DISCUSSIONThis study will evaluate the efficacy and safety of MSC therapy in patients who have failed first-line steroid treatment for grade II-IV aGVHD.TRIAL REGISTRATIONChinese Clinical Trial Registry (ChiCTR), ChiCTR2000035740. Registered on 16 August 2020.

100 Deals associated with Amimestrocel

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Acute Graft Versus Host Disease	CN	Bosheng Excellence Biotechnology (Beijing) Co., Ltd.	02 Jan 2025

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Idiopathic Pulmonary Fibrosis	IND Approval	CN	Bosheng Excellence Biotechnology (Beijing) Co., Ltd.	05 Nov 2024

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ChiCTR2000035740 (Pubmed) Manual	Phase 2	Steroid Refractory Graft Versus Host Disease Second line	78	Amimestrocel (intention-to-treat)	(npayayoqzy) = oqcgdjpseh pvhficwfvh (wfhfyhghop ) View more	Not Applicable	25 Nov 2024
ChiCTR2000035740 (Pubmed) Manual	Phase 2	Steroid Refractory Graft Versus Host Disease Second line	78	Placebo (intention-to-treat)	(npayayoqzy) = vbhlwxjpls pvhficwfvh (wfhfyhghop ) View more	Not Applicable	25 Nov 2024
ChiCTR2000035740 (EHA 12023 \| EHA 22023) Manual	Phase 2	Steroid Refractory Graft Versus Host Disease	78	Placebo	(btkbuloiac) = twqtwhfecd eecuyxpblj (lqchydcfdc ) View more	Positive	11 May 2023