A Clinical Study to Evaluate the Efficacy and Safety of REGEND001 Cell Therapy on Idiopathic Pulmonary Fibrosis (IPF)

NCT06081621 | Completed Phase 2

• 1 other identifier: REGEND001-IPF-231-V1.3
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 4

Brief Summary

Idiopathic pulmonary fibrosis (IPF) is a serious chronic (long term) disease with injury of lung tissues. REGEND001 is a cell therapy product, made from bronchial basal cells with ability to regenerate lung tissue, is promising to IPF treatment. This is a multi-center, randomized, double-blinded, parallel and placebo-controlled phase II clinical study to evaluate the efficacy and safety of REGEND001 in IPF patients.

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• Comparison of the area under the curve (AUC) of DLCO measured values at each visit from baseline to week 24 between the REGEND001 group and the placebo group.

  DLCO is measured by the single-breath method. Improvement is defined as an increase in DLCO from baseline.

  12 and 24 weeks after treatment

Secondary Outcomes (1)

• Change from baseline in lung diffusing capacity

  12 and 24 weeks after treatment

Other Outcomes (25)

• Change from baseline in lung ventilatory capacity

  12 and 24 weeks after treatment

• Progression-free survival (PFS)

  Within 24 weeks after treatment

• Change from baseline in St. George's respiratory questionnaire (SGRQ) scale

  12 and 24 weeks after treatment

Study Arms (2)

REGEND001

EXPERIMENTAL

Biological: REGEND001

Placebo

PLACEBO COMPARATOR

Biological: Placebo

Interventions

REGEND001 BIOLOGICAL

REGEND001: 1-1.5×10\^6 bronchial basal cells/kg administrated by bronchoscopy.

REGEND001

Placebo BIOLOGICAL

Placebo: Sodium chloride injection administrated by bronchoscopy.

Placebo

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, aged between 40 to 75;
• Subjects diagnosed with IPF according to guidelines for the diagnosis of idiopathic pulmonary fibrosis 2022 edition;
• Subjects with DLCO (measured/predicted value) ≥30% and \<80%, and FVC (measured/predicted value) ≥50% within 3 months prior to screening
• Subjects tolerant to bronchofiberscope;
• Subjects tolerant to test of lung function;
• Subjects able to voluntarily sign the informed consent and cooperate with the completion of pulmonary function tests;

You may not qualify if:

• Female subject who is pregnant, nursing, or planning to be pregnant in half a year after using this product (or male subjects planning to have a pregnant spouse);
• At the time of screening, subject who is positive in each of treponema pallidum antibody (TP-Ab), human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody test, except the following: (1) Hepatitis B virus carriers (only HBsAg positive, no hepatitis symptoms and signs, all liver function tests are normal); (2) Cured hepatitis C patients with negative result in HCV ribonucleic acid (RNA) test.
• Subject with malignant tumors or a history of malignant tumors;
• Subject with severe anemia, poorly controlled agranulocytosis and thrombocytopenia at screening;
• Subject at risk of suicide or has a history of mental illness or epilepsy at the time of screening;
• Subject with severe arrhythmias or atrioventricular block of degree II or above, shown by 12-lead Electrocardiogram (ECG);
• Subject who participated in other interventional clinical trials in the past 3 months;
• Subject assessed as inappropriate to participate in this clinical trial by investigators.

Sponsors & Collaborators

• Regend Therapeutics: lead
• Peking Union Medical College Hospital: collaborator
• RenJi Hospital: collaborator
• Ruijin Hospital: collaborator
• The Second Affiliated Hospital of Xiamen Medical College: collaborator

Study Sites (4)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Location

The Second Affiliated Hospital of Xiamen Medical College

Xiamen, Fujian, 361021, China

Location

Ruijin Hospital, Shanghai Jiaotong University School Of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

Renji Hospital, Shanghai Jiaotong University School Of Medicine

Shanghai, Shanghai Municipality, 200127, China

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2023
• First Posted: October 13, 2023
• Study Start: December 11, 2023
• Primary Completion: March 14, 2025
• Study Completion: March 14, 2025
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)