RecruitingPhase 1Phase 2NCT06610773

HUC-MSC for Treatment of High-risk HPV Infection

Effectiveness and Safety of Human Umbilical Cord Mesenchymal Stem Cells for the Treatment of HPV High-risk Infection

Sponsor

Shanghai East Hospital

Enrollment

60 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

Human Papillomavirus Viruses Mesenchymal Stem Cells

Summary

To evaluate the safety and initial effectiveness of human umbilical cord mesenchymal stem cells in HPV clearance.

Eligibility

Sex: FEMALEMin Age: 25 YearsMax Age: 60 Years

Inclusion Criteria5

Women aged 25-60 with a sexual history of more than 2 years;
Confirmed HPV infection by HPV-24 test;Patients diagnosed with high-risk human papillomavirus (HR-HPV) persistent infection; (note: the HR HPV: HPV 16/18/31/33/35/39/45/51/52/53/56/58/59/66/68; 15 types)
The subjects were not participating in other clinical trials at the same time, and had no other anti-HPV drugs or intervention therapy recently;
If the pregnancy test is negative and the subjects have fertility potential, they agree to use effective contraception during the study period and within 6 months of completion or termination of the study;
Voluntarily participate in and agree to cooperate in accordance with the requirements of the program, and sign the informed consent.

Exclusion Criteria10

Women who are preparing for pregnancy, pregnancy or breastfeeding;
Pathological diagnosis of high-grade squamous intraepithelial lesion (HSIL) or cervical cancer;
Previous HPV vaccinations;
A history of severe drug allergies, or allergies to stem cell products or other biologics;
Previous cervical site physical therapy or related surgical history;
Patients with severe immune dysfunction (such as AIDS, systemic lupus erythematosus and other immune system diseases or history of organ transplantation, malignant tumor chemotherapy history), serious cardiovascular, liver, kidney, nervous, hematopoietic system diseases or malignant tumors, or mental diseases;
Recent use of other antiviral drugs, immunosuppressants, immunomodulators or steroid hormones that affect the immune system;
Patients with acute genital tract inflammation or pelvic inflammation;
Those who have participated in or are participating in clinical trials of other drugs within three months;
Other conditions considered inappropriate by the investigator for inclusion in this clinical trial.

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Interventions

BIOLOGICALhUC-MSCs

1×10\^6/Kg hUC-MSCs (suspended in 100 mL normal saline containing 5% albumin) are infused intravenously to patients at a controlled rate of 60-80 drops/min.

BIOLOGICALSaline+albumin

Normal saline containing 5% albumin had a similar suspension and appearance package to hUC-MSCs, but no MSCs