HUC-MSC for Treatment of High-risk HPV Infection
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age25-60
SponsorShanghai East Hospital
About this trial
To evaluate the safety and initial effectiveness of human umbilical cord mesenchymal stem cells in HPV clearance.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- hUC-MSCs
- Saline+albumin
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov