NCT06987214 REGEND001 Autologous Basal Layer Stem Cell Transplantation for Bronchiectasis: A Translational Application Study
| NCT ID | NCT06987214 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Ruijin Hospital |
| Condition | Bronchiectasis Adult |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-06-18 |
| Primary Completion | 2029-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 10 participants in total. It began in 2025-06-18 with a primary completion date of 2029-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This clinical trial aims to evaluate the safety and efficacy of REGEND001, an autologous basal layer stem cell transplantation therapy, in patients with chronic structural lung disease (bronchiectasis). The treatment involves harvesting bronchial basal layer stem cells from the patient, expanding them ex vivo, and reintroducing them via bronchoscopic infusion to repair damaged lung tissue.
Eligibility Criteria
Inclusion Criteria: 1. Age 25-80 years. 2. Confirmed diagnosis of bronchiectasis. 3. FEV1 ≥35% predicted; DLCO ≥30% and \<80% predicted. Exclusion Criteria: 1. Pregnancy, lactation, or plans for pregnancy within 1 year. 2. Active malignancy or history of malignancy. 3. Positive serology for HIV, HBV, HCV, or syphilis.
Frequently Asked Questions
Who can join the NCT06987214 clinical trial?
This trial is open to participants of all sexes, aged 25 Years or older, up to 80 Years, studying Bronchiectasis Adult. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06987214 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06987214 currently recruiting?
Yes, NCT06987214 is actively recruiting participants. Visit ClinicalTrials.gov or contact Ruijin Hospital to inquire about joining.
Where is the NCT06987214 trial being conducted?
This trial is being conducted at Qionghai, China, Shanghai, China.
Who is sponsoring the NCT06987214 clinical trial?
NCT06987214 is sponsored by Ruijin Hospital. The trial plans to enroll 10 participants.