Efficacy & Safety of Pneumostem® for IVH in Premature Infants (Phase 2a)

Clinical Trial Summary

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.

See also
Status	Clinical Trial	Phase
Completed	`NCT03021681` - An Exploratory Study on the Treatment of Chronic Obstructive Pulmonary Disease With Autologous Bronchial Basal Cell Transplantation	N/A
Completed	`NCT02796196` - Prescribed Physical Activity in Improving Sleep and Physical Performance in Patients Undergoing Stem Cell Transplant
Withdrawn	`NCT04428918` - Biospecimen Procurement for Immunological Landscape Studies Following Hematopoietic Cell Transplantation

See also

Status

Clinical Trial

Phase

Completed

NCT03021681 - An Exploratory Study on the Treatment of Chronic Obstructive Pulmonary Disease With Autologous Bronchial Basal Cell Transplantation

N/A

Completed

NCT02796196 - Prescribed Physical Activity in Improving Sleep and Physical Performance in Patients Undergoing Stem Cell Transplant

Withdrawn

NCT04428918 - Biospecimen Procurement for Immunological Landscape Studies Following Hematopoietic Cell Transplantation

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT02890953
Study type	Interventional
Source	Samsung Medical Center
Contact	So Yoon Ahn, MD. Ph.D
Phone	+821040380460
Email	soyoon.ahn@samsung.com
Status	Recruiting
Phase	Phase 2
Start date	March 28, 2017
Completion date	December 2021

Efficacy and Safety of Pneumostem® for IVH in Premature Infants (Phase 2a)

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms