Status:
RECRUITING
HUC-MSC for Treatment of High-risk HPV Infection
Lead Sponsor:
Shanghai East Hospital
Conditions:
Human Papillomavirus Viruses
Mesenchymal Stem Cells
Eligibility:
FEMALE
25-60 years
Phase:
PHASE1
PHASE2
Brief Summary
To evaluate the safety and initial effectiveness of human umbilical cord mesenchymal stem cells in HPV clearance.
Detailed Description
Cervical cancer is one of the most common malignant tumors of the female reproductive system with the highest incidence. Nearly 99.7% of cervical cancer is caused by HPV infection. Studies have shown ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 10 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06610773
Start Date
March 1 2024
End Date
September 10 2026
Last Update
September 24 2024
Active Locations (1)
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1
Shanghai Shanghai East Hospital, Tongji University School of Medicine
Shanghai, Shanghai Municipality, China, 200120