HUC-MSC for Treatment of High-risk HPV Infection
Recruiting now · Phase 1/Phase 2
Conditions studied: Human Papillomavirus Viruses, Mesenchymal Stem Cells
In brief
To evaluate the safety and initial effectiveness of human umbilical cord mesenchymal stem cells in HPV clearance.
Key facts
- Study ID
- NCT06610773
- Run by
- Shanghai East Hospital
- People needed
- 60
- Starts
- 2024-03-01
- Expected to finish
- 2026-09-10
- Last updated by the study team
- 2024-09-24
Who can join
Age: 25 and older, up to 60. Sex: female. Healthy volunteers: not accepted.
You may qualify 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 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;
- Voluntarily participate in and agree to cooperate in accordance with the requirements of the program, and sign the informed consent.
You may not qualify 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 transplantation, malignant tumor chemotherapy history), serious cardiovascular, liver, kidney, nervous, hematopoietic system diseases or malignant tumors, or mental diseases;
- 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.
Where it is running
- Shanghai Shanghai East Hospital, Tongji University School of Medicine — Shanghai, Shanghai Municipality, China (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.