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Clinical Trials in China / NCT06610773
Recruiting Phase 1/2

HUC-MSC for Treatment of High-risk HPV Infection

NCT06610773 · tracked via the Priya Life Science China tracker
Phase
Phase 1/2
Started
2024-03-01
Last updated
2024-09-24

Condition(s) studied

Human Papillomavirus VirusesMesenchymal Stem Cells

Investigational drug(s) / intervention(s)

hUC-MSCsSaline+albumin →

hUC-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.

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

Study summary

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

Eligibility

Sex
FEMALE
Min age
25 Years
Max age
60 Years
Healthy volunteers
No
Inclusion Criteria: 1. Women aged 25-60 with a sexual history of more than 2 years; 2. 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) 3. The subjects were not participating in other clinical trials at the same time, and had no other anti-HPV drugs or intervention therapy recently; 4. 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; 5. Voluntarily participate in and agree to cooperate in accordance with the requirements of the program, and sign the informed consent. Exclusion Criteria: 1. Women who are preparing for pregnancy, pregnancy or breastfeeding; 2. Pathological diagnosis of high-grade squamous intraepithelial lesion (HSIL) or cervical cancer; 3. Previous HPV vaccinations; 4. A history of severe drug allergies, or allergies to stem cell products or other biologics; 5. Previous cervical site physical therapy or related surgical history; 6. 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; 7. Recent use of other antiviral drugs, immunosuppressants, immunomodulators or steroid hormones that affect the immune system; 8. Patients with acute genital tract inflammation or pelvic inflammation; 9. Those who have participated in or are participating in clinical trials of other drugs within three months; 10. Other conditions considered inappropriate by the investigator for inclusion in this clinical trial.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Shanghai Shanghai East Hospital, Tongji University School of Medicine Shanghai Shanghai Municipality Recruiting

More Shanghai East Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06610773 on ClinicalTrials.gov ↗ ← All trials in China