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

To reduce the risk of critical limb ischemia (CLI) in diabetic patients, repair local ulcers in the limbs of diabetic patients, and avoid the occurrence of amputation, Academician Van der Rijt has developed autoregulatory monocytes (OPM cells). These are derived from monocytes extracted from the peripheral blood of the patient, cultured in vitro using cytokines, which endow them with the capability to promote angiogenesis and tissue repair. Preliminary animal experiments and European clinical studies have shown that injecting OPM cells into the muscle around diabetic ulcers increases the paracrine of proteins related to angiogenesis and tissue recovery, promotes the regeneration and repair of tissue structure and function, and activates precursor cells or naive cells (including tissue-oriented stem cells) that are dormant or suppressed within tissues and organs. These cells replace and reconstruct the cells and tissues that have been damaged and lost function due to disease, thereby restoring physiological functions.

To explore whether this therapy can repair local ulcers in the limbs of diabetic patients, Shanghai Oriental Hospital, in collaboration with Van der Rijt (Shanghai) Biotechnology Co., Ltd., has initiated this exploratory clinical study to evaluate the safety and preliminary efficacy of OPM cells in the treatment of diabetic ulcers.

Study Objective： As a clinical study initiated by researchers, this study aims to explore the safety and preliminary efficacy of OPM cells in reducing complications in diabetic foot patients. The study will evaluate the potential of OPM cells to improve critical limb ischemia (CLI) and promote wound healing in diabetic foot ulcers.

Study Overall Design： 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. Before treatment, measurements will be taken of the size of the ulcer wound, the immune cell count of the ulcer exudate, and vascular CTA detection, among others, and recorded.

On day 0, a clean and tidy single room will be arranged as the treatment room. Venous blood will be drawn from each participant sequentially, 200ml per participant, and then cultured in the cell laboratory for 4 days according to their assigned numbers. On day 4, samples will be taken for endotoxin, bacterial and mycoplasma testing, cell counting, and flow cytometry analysis. Once approved, OPM cells will be collected and suspended in 5% human serum albumin. The harvested OPM cells will be stored at 2~8°C and transported to the hospital. Upon arrival at Shanghai Oriental Hospital, sample testing will be conducted first. Only after the samples pass testing will the patients receive intramuscular injections. The OPM cells must be injected into the muscle around the ulcer within 6 hours after leaving the laboratory.

Wound assessments will be conducted weekly after injection. Physical examinations and vital signs (pulse, blood pressure) will be recorded at weeks 4, 8, 12, 16, 20, and 24. Clinical tests (blood routine, tumor markers, etc.) will be performed at week 12. Vascular CTA and immune cell count in wound lavage fluid will be detected at week 24 after cell intervention, and a final examination will be conducted at week 24.

The safety and efficacy of OPM cells in treating diabetic ulcer patients will be determined based on the healing of the wound size, the increase in the number of immune cells in the wound lavage fluid, and the increase in vascular collateral circulation.