Autonomous Regulatory Monocytes (OPM Cells) for the Treatment of Diabetic Foot in a Single-arm Open-label Clinical Study

EARLY_PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

October 31, 2024

Primary Completion Date

September 30, 2025

Study Completion Date

October 31, 2025

Conditions
Diabetic Foot Ulcer
Interventions
BIOLOGICAL

Diabetic foot ulcer treatment

The trial is designed to last up to 26 weeks, including a screening period of 1 week, a treatment period of 1 week, and an observation period of 24 weeks. According to the inclusion criteria, 10 diabetic patients with ulcers will be clinically screened, and after signing the informed consent form, they will be assigned a number. Post-injection of OPM cells, wound assessments are conducted weekly, with physical examinations and vital signs (pulse, blood pressure) recorded at weeks 4, 8, 12, 16, 20, and 24. Clinical laboratory tests (routine blood tests, tumor markers, etc.) are performed at week 12. Vascular CTA and immune cell count in wound lavage fluid are conducted at week 24 post-cellular intervention, followed by a final examination at week 24.

Trial Locations (1)

200123

Shanghai East Hospital, Shanghai

All Listed Sponsors
collaborator

Faendrich (Shanghai) Biotechnology Co., Ltd

UNKNOWN

lead

Shanghai East Hospital

OTHER

NCT06621303 - Autonomous Regulatory Monocytes (OPM Cells) for the Treatment of Diabetic Foot in a Single-arm Open-label Clinical Study | Biotech Hunter | Biotech Hunter