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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
hUC-MSCs
Biological/Vaccine1×10\^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
Biological/VaccineNormal saline containing 5% albumin had a similar suspension and appearance package to hUC-MSCs, but no MSCs
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Experimental groupExperimental treatment 1 intervention
Group B: Control groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Adverse events-The incidence rate of allergic reaction
The allergic reaction rate on the 1st day, 1st week, 4th week, 12th week, and 36th week after the infusion.
Time frame
1day,1st,4th,12th,and 36th week2
The 24 type HPV viral load
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.
Time frame
-28th~0day,4th,12th,and 36th weekSecondary outcomes
1
The percentage of CD3+
The peripheral blood serum of the patients will be collected to detect the percentage（%）of CD3+ before the infusion of hUC-MSCs (Any day from 28th to 1st day) and on the 1st day, 1st week, 4th week, 12th and 36th week after the infusion.
Time frame
-28th~0day,1day,1st,4th,12th,and 36th week2
The percentage of CD4+
The peripheral blood serum of the patients will be collected to detect the percentage（%）of CD4+ before the infusion of hUC-MSCs (Any day from 28th to 1st day) and on the 1st day, 1st week, 4th week, 12th and 36th week after the infusion.
Time frame
-28th~0day,1day,1st,4th,12th,and 36th week3
The percentage of CD8+
The peripheral blood serum of the patients will be collected to detect the percentage（%） of CD8 before the infusion of hUC-MSCs (Any day from 28th to 1st day) and on the 1st day, 1st week, 4th week, 12th and 36th week after the infusion.
Time frame
-28th~0day,1day,1st,4th,12th,and 36th week4
The percentage of CD19+
The peripheral blood serum of the patients will be collected to detect the percentage（%）of CD19+ before the infusion of hUC-MSCs (Any day from 28th to 1st day) and on the 1st day, 1st week, 4th week, 12th and 36th week after the infusion
Time frame
-28th~0day,1day,1st,4th,12th,and 36th weekSponsors and contacts
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Source ClinicalTrials.gov