Recruiting soon

Stem Cell Therapy for Interstitial Lung Disease

What is being tested

NCR101 injection

Biological

Who is being recruted

Lung Diseases

+ Respiratory Tract Diseases

+ Lung Diseases, Interstitial

Over 18 Years

+13 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1 & 2

Interventional

Study Start: March 2025

See protocol details

Summary

Principal SponsorNuwacell Biotechnologies Co., Ltd.

Study ContactTao Ren, M.PharmMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2025

Actual date on which the first participant was enrolled.

This clinical trial is exploring a new potential treatment for people with interstitial lung disease (ILD), a group of conditions that cause inflammation and scarring in the lungs, leading to breathing difficulties and potentially severe complications. Current treatments, like Pirfenidone and Nintedanib, help manage symptoms but do not stop the disease from progressing or provide a cure. Given the serious impact of ILD on health and quality of life, there is a significant need for new treatments that can more effectively address these challenges. In this study, researchers are testing the safety and effectiveness of an injection called NCR101, which is derived from specialized stem cells, in people with ILD. Participants will receive this experimental treatment, and researchers will monitor them to see how well their bodies tolerate the injection and if it improves their lung function or symptoms. By carefully observing these effects, the study aims to determine if this new treatment could be a promising option for those affected by ILD.

Official TitleA Phase I/II, Open Label, Single Arm, Dose Escalation and Dose Expansion Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of Human Induced Pluripotent Stem Cell Derived Mesenchymal Stromal Cells (NCR101) Injection in the Treatment of Subjects With Interstitial Lung Disease

NCT06825169

Principal SponsorNuwacell Biotechnologies Co., Ltd.

Study ContactTao Ren, M.PharmMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Lung DiseasesRespiratory Tract DiseasesLung Diseases, Interstitial

Criteria

7 inclusion criteria required to participate

Age>18 years old (including threshold), gender not limited;

Meets the diagnosis of interstitial lung disease;

Screening for interstitial lung disease diagnosed by pulmonary imaging within the first 6 months;

For patients undergoing glucocorticoid therapy at the time of screening: the background treatment remained stable during the study period;

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6 exclusion criteria prevent from participating

Individuals with a history of severe allergies or allergies to the main active ingredients or excipients of the investigational drug;

Individuals who have been hospitalized for three or more times due to acute exacerbation of ILD or other respiratory diseases within the previous year prior to screening;

Individuals with a history of mechanical ventilation (invasive or non-invasive) within the past month prior to screening, or those currently requiring oxygen therapy (oxygen therapy duration>15 hours/day);

Individuals who have contracted infectious pneumonia or require intravenous anti-infective treatment within the previous month; Previous history of tuberculosis

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Cohort1:Low dose NCR101 injection; Cohort2:High dose NCR101 injection

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has no location dataSave this study to your profile to know when the location data is available.

Recruiting soonNo study centers