A clinical trial is a research study involving human participants that evaluates the safety, effectiveness, and potential benefits of investigational therapies, medical procedures, or diagnostic methods.

Before a new therapy can become widely available, it must be carefully evaluated in clinical trials and approved by regulatory authorities such as the National Medical Products Administration (NMPA).

Clinical trials are typically conducted in several phases:

Phase Ⅰ
The first stage of testing in humans. These studies focus on evaluating safety, tolerability, and how the therapy behaves in the body.

Phase Ⅱ
These trials involve a larger group of patients and assess preliminary effectiveness while continuing to evaluate safety.

Phase Ⅲ
Phase Ⅲ trials enroll a large number of participants to confirm effectiveness, monitor side effects, and compare the investigational therapy with existing standard treatments.

Results from Phase Ⅲ trials are often used to support regulatory approval.

An investigator-initiated trial (IIT) is a clinical study led by an independent physician or academic institution. These studies may explore new therapeutic approaches, investigate novel combinations of therapies, or generate additional scientific insights.

By contrast, IND clinical trials are typically sponsored by biopharmaceutical companies and are conducted as part of the regulatory pathway toward potential product approval.

Participation in clinical trials may provide access to innovative therapies that are not yet widely available. Participants also receive close medical monitoring from specialized research teams throughout the study.

Importantly, clinical trial participation helps advance medical science and contributes to the development of new treatments that may benefit future patients. Diverse participation also helps ensure that new therapies are safe and effective across different patient populations.

REGEND001, also called Aeriotemcel, is a potential first-in-class autologous airway basal stem cell therapy for chronic pulmonary diseases including COPD, IPF, ILD, and bronchiectasis; it uses autologous airway basal stem cells capable of regenerating and repairing damaged pulmonary tissue.

REGEND003 is an investigational autologous kidney progenitor cell therapy.

The therapy uses kidney progenitor cells derived non-invasively from a patient’s urine. After expansion using proprietary technologies, the cells are reintroduced into the patient to support regeneration of kidney tissue.

REGEND003 is being developed for patients with chronic kidney disease (CKD), including diabetic kidney disease (DKD) associated with Type 2 diabetes.

Participant safety is the highest priority in every clinical trial. Clinical studies are conducted under strict regulatory and ethical oversight. Study protocols must be approved by regulatory authorities and institutional ethics committees before the trial begins. Participants are closely monitored throughout the study, and any adverse events are evaluated and managed by the research team.

Participation in a clinical trial may involve risks related to medical procedures or investigational therapies. Before joining a study, participants will receive detailed information about potential risks and benefits through the informed consent process. You should carefully review this information and discuss any questions with the study team before deciding whether to participate.

All personal information collected during a clinical trial is handled confidentially. 

Participants are assigned a unique study identification number, and personal identifiers are not included in research data used for analysis or publication.

Access to participant information is restricted to authorized study personnel.

Screening assessments help determine whether a participant meets the eligibility criteria for a study and ensure that participation is safe.

Screening procedures may include:

1、Review of the informed consent form

2、Medical history review and physical examination

3、Blood and urine tests 

The specific procedures will vary depending on the study.

Each clinical study includes defined inclusion and exclusion criteria. If you do not meet the criteria for a specific study, other research opportunities may become available in the future.

Regend Therapeutics continues to expand its clinical research programs and collaborations with leading hospitals and research institutions.

Participants will undergo a series of clinical evaluations and tests throughout the study, including laboratory testing and imaging assessments.

Depending on the study design, participants may receive the investigational therapy or be assigned to a control group. All procedures are performed under medical supervision.

Participants are expected to attend scheduled study visits and follow-up appointments.

All study-related costs are covered by the sponsor, including examinations, treatment, and follow-up visits. There is no cost to participants for taking part in the study.

Participants will attend scheduled study visits and undergo medical evaluations designed to monitor safety and treatment response. These assessments may include laboratory tests, imaging studies, and physical examinations. Study procedures will always be conducted under medical supervision.

Follow-up visits are an essential part of clinical research.

Short-term follow-up
Occurs shortly after treatment to monitor immediate safety and treatment response.

Long-term follow-up
May occur periodically throughout the study to evaluate long-term safety and treatment outcomes.

Yes. Participation in a clinical trial is entirely voluntary.

Participants may withdraw from a study at any time without penalty and without affecting their future medical care.

If you have additional questions about participating in a clinical study, please contact the study team using the information provided in your informed consent materials.

You may also visit our Contact page for additional information.

After the study is completed and data analysis is finalized, results may be shared through:

1、Scientific publications

2、Medical conferences

3、Regulatory disclosures

4、Company communications

Participants may also receive general study updates through newsletters or study communications.

If any information becomes available that could affect your health or safety, the research team will inform you directly.