Drug intelligence / Profile preview

normal saline placebo (RSUP Persahabatan)

Development stage
Unknown
Lead developer
RSUP Persahabatan
Modality
Small Molecules
Administration
Intravenous
01

Overview

Normal saline placebo is the control intervention used in a Phase 2, randomized, double-blind, placebo-controlled clinical trial conducted by RSUP Persahabatan (Persahabatan General Hospital) in Jakarta, Indonesia. The trial evaluates the efficacy and safety of allogeneic human umbilical cord mesenchymal stem cells (UC-MSCs) as an adjuvant therapy for patients aged 40-75 with Group E Chronic Obstructive Pulmonary Disease (COPD) who are receiving standard triple inhalation therapy. The placebo consists of a 100 mL intravenous infusion of 0.9% sodium chloride (normal saline), administered at a rate of 20 mL/hour to match the volume, appearance, and administration schedule of the active UC-MSC treatment. As a placebo, it contains no active pharmacological or biological ingredients and serves as a baseline comparator to assess the therapeutic impact of the stem cell intervention on pulmonary function, quality of life, and inflammatory biomarkers.

Other names
normal saline placebo-RSUP Persahabatan-chronic obstructive pulmonary disease0.9% sodium chloridenormal saline

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