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)
Adverse events-The incidence rate of allergic reaction — 1day,1st,4th,12th,and 36th week The allergic reaction rate on the 1st day, 1st week, 4th week, 12th week, and 36th week after the infusion.
The 24 type HPV viral load — -28th~0day,4th,12th,and 36th week HPV24 genotypes test is classified from female genitourinary secretions and exfoliating cells of cervix by fluorescent PCR before the infusion of hUC-MSCs (Any day from 28th to 1st day) and on the 4th week, 12th week, and 36th week after the infusion.
Trial sites (1)
Facility
City
Region
Status
Shanghai Shanghai East Hospital, Tongji University School of Medicine
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.
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