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NCT06230822

Safety, Tolerability and Efficacy of VUM02 Injection in Treatment of Idiopathic Pulmonary Fibrosis (IPF)

A Phase I Open Label, Dose Escalation Study to Characterize the Safety, Tolerability, and Efficacy of VUM02 Injection in Subjects With Idiopathic Pulmonary Fibrosis
Wuhan Optics Valley Vcanbiopharma Co., Ltd.·Phase 1·ClinicalTrials.gov·drugRecruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Idiopathic Pulmonary Fibrosis
Drug/Device/Intervention
VUM02 Injection
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Wuhan Optics Valley Vcanbiopharma Co., Ltd.
Funder
Vcanbio Cell and Gene Engineering Corp., Ltd.
Location
Beijing,Chengdu,Guangzhou,Kashi, China
Timeline & enrollment
Phase
Phase 1
Start date
Feb 01, 2024
End date
Dec 01, 2026
Enrollment
9 participants
Primary outcome

Incidence and severity of cell therapy-related adverse events (AEs) as assessed by CTCAE (V5.0),Maximum tolerated dose (MTD)

Summary

This study is a single-arm, multiple-dose, dose-escalation, open-label multicenter clinical
 trial, aiming to evaluate the safety, tolerability, and preliminary efficacy of VUM02
 Injection for treatment of idiopathic pulmonary fibrosis (IPF). VUM02 Injection (Human
 Umbilical Cord Tissue-derived Mesenchymal Stem Cells Injection, hUCT-MSC) is an allogeneic
 cell therapy product comprising culture-expanded Mesenchymal Stem Cells derived from the
 human umbilical cord tissue. The product is cryopreserved with the amount of 5 x 10^7 cells
 per 10 mL per bag (5 x 10^6 cells/mL). This study is a multiple-dose tolerability study
 following the 3+3 dose escalation principle and progressing from the low-dose group to the
 high-dose group sequentially. Three to six patients will be enrolled in each dose group and
 administered every 3 days for a total of 3 doses.

ICD-10 classifications
Other interstitial pulmonary diseases with fibrosisCystic fibrosis with pulmonary manifestationsCystic fibrosisGraphite fibrosis (of lung)Pulmonary heart disease, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06230822
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06230822 through Pure Global AI's free database. This Phase 1 trial is sponsored by Wuhan Optics Valley Vcanbiopharma Co., Ltd. and is currently Recruiting. The study focuses on Idiopathic Pulmonary Fibrosis. Target enrollment is 9 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.