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New treatment option for Human Papillomavirus Viruses
Official title HUC-MSC for Treatment of High-risk HPV Infection
ClinicalTrials.gov ID: NCT06610773
What this study is testing
What is hUC-MSCs?
hUC-MSCs is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for human papillomavirus viruses.
Also referred to as Umbilical Cord Mesenchymal Stem Cells.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To evaluate the safety and initial effectiveness of human umbilical cord mesenchymal stem cells in HPV clearance.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 25 to 60, women only
You may be able to join if
- 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...
- The people 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 people have fertility potential, they agree to use effective contraception during the study period and...
- Voluntarily participate in and agree to cooperate in accordance with the requirements of the program, and sign the informed consent.
You likely can't join if
- 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...
See the full eligibility criteria
- 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 people 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 people 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 25 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.