HUC-MSC for Treatment of High-risk HPV Infection

Launched by SHANGHAI EAST HOSPITAL · Sep 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment using human umbilical cord mesenchymal stem cells to help women clear high-risk human papillomavirus (HPV) infections. The goal is to see if this treatment is safe and if it can effectively help women who have been diagnosed with high-risk HPV, which is linked to cervical cancer and other health issues. The trial is currently recruiting participants who are women aged 25 to 60 with a confirmed HPV infection and a sexual history of more than two years.

To be eligible for this trial, participants must not be pregnant or breastfeeding and should not have had any recent HPV vaccinations or treatments that could affect the study results. Additionally, they must be willing to use effective contraception if they have the potential for pregnancy. Participants can expect to be closely monitored during the study to ensure their safety and to gather information about how well the treatment works. This trial is a chance to contribute to important research that could improve HPV treatment options for women in the future.

Gender

FEMALE

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.