Using stem cells to treat high-risk HPV infections

Effectiveness and Safety of Human Umbilical Cord Mesenchymal Stem Cells for the Treatment of HPV High-risk Infection

This study is testing if using stem cells from umbilical cords can help women aged 25-60 clear high-risk HPV infections and reduce their chances of developing cervical cancer.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 25 Years to 60 Years
• Sex: Female
• Sponsor: Shanghai East Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06610773 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and initial effectiveness of human umbilical cord mesenchymal stem cells (hUC-MSCs) in clearing high-risk human papillomavirus (HR-HPV) infections, which are a significant risk factor for cervical cancer. The study focuses on women aged 25-60 with persistent HR-HPV infections, aiming to reduce the incidence of cervical intraepithelial neoplasia (CIN) and cervical cancer through innovative stem cell therapy. Participants will receive either hUC-MSCs or a saline and albumin control treatment, with careful monitoring of outcomes. The trial is designed to address an urgent clinical need for effective interventions in patients with long-term HPV infections.

Who should consider this trial

Good fit: Ideal candidates for this study are women aged 25-60 with a confirmed diagnosis of persistent high-risk HPV infection.

Not a fit: Patients who are pregnant, breastfeeding, or have been diagnosed with high-grade squamous intraepithelial lesions or cervical cancer will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the risk of cervical cancer in women with persistent high-risk HPV infections.

How similar studies have performed: While the use of stem cells for HPV treatment is a novel approach, there have been other studies exploring stem cell therapies for various conditions, but this specific application remains largely untested.

Eligibility criteria

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai Shanghai East Hospital, Tongji University School of Medicine — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Principal investigator: Fang Li, M.D,.PH.D. — Shanghai East Hospital, Shanghai Tongji University
• Study coordinator: Jingjing Liu, M.D,.PH.D.

Conditions Human Papillomavirus Viruses; Mesenchymal Stem Cells; HPV; hUC-MSC