Delving into the Latest Updates on Pneumostem with Synapse

Overview

Basic Info

Drug Type

Mesenchymal stem cell therapy

Synonyms-

Target-

Mechanism-

Therapeutic Areas

Congenital DisordersRespiratory DiseasesOther Diseases

Active Indication

Bronchopulmonary Dysplasia

Inactive Indication

Obstetric Labor, Premature

Originator Organization

MEDIPOST Co., Ltd.

Active Organization

MEDIPOST Co., Ltd.

Inactive Organization-

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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This is a follow-up study to investigate the long-term safety and efficacy of PNEUMOSTEM® versus placebo, for the treatment of BPD in premature infants. Subjects who participated in and completed the initial stage of the Phase II trial (NCT03392467) will be followed-up until 60 months of corrected age

Start Date05 Jul 2019

Sponsor / Collaborator

MEDIPOST Co., Ltd.

NCT03392467 / RecruitingPhase 2

A Multi-center, Randomized, Double-blind, Parallel, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of PNEUMOSTEM for the Prevention and Treatment of Severe Bronchopulmonary Dysplasia in Premature Infants

This study is to evaluate the efficacy and safety of PNEUMOSTEM® for the Prevention and Treatment of Severe Bronchopulmonary Dysplasia (Severe BPD) in Premature Infants. Half of subjects will receive PNEUMOSTEM, while the other half will receive a placebo.

Start Date13 Aug 2018

Sponsor / Collaborator

MEDIPOST Co., Ltd.

NCT02890953 / Unknown statusPhase 2IIT

Efficacy and Safety Evaluation of Pneumostem® Versus a Control Group for Treatment of IVH in Premature Infants (Phase 2a)

The objective of this study is to evaluate the efficacy and safety of a single intraventricular administration of Pneumostem® for treatment of Intraventricular hemorrhage (IVH) in high-risk premature infants by comparing Pneumostem-treated group with a control group.

Start Date28 Mar 2017

Sponsor / Collaborator

Samsung Medical Center

100 Clinical Results associated with Pneumostem

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100 Translational Medicine associated with Pneumostem

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100 Patents (Medical) associated with Pneumostem

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100 Deals associated with Pneumostem

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Bronchopulmonary Dysplasia	Phase 2	KR	MEDIPOST Co., Ltd.	01 Apr 2013
Obstetric Labor, Premature	Discovery	KR	MEDIPOST Co., Ltd.	01 Apr 2013

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01828957 (Pubmed) Manual	Phase 2	Bronchopulmonary Dysplasia	66	Pneumostem	(fpqaedgcmn) = plrhikqiae slbxdqcfma (tifuvpgjny ) View more	Positive	01 Aug 2021
				Placebo	(fpqaedgcmn) = eervwcwzcn slbxdqcfma (tifuvpgjny ) View more