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Clinical Trial NCT06610773 for Human Papillomavirus Viruses, Mesenchymal Stem Cells is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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HUC-MSC for Treatment of High-risk HPV Infection Phase 1, Phase 2 60
Clinical Trial NCT06610773 is designed to study Treatment for Human Papillomavirus Viruses, Mesenchymal Stem Cells. It is a Phase 1 Phase 2 interventional study that is recruiting, having started on March 1, 2024, with plans to enroll 60 participants. Led by Shanghai East Hospital, it is expected to complete by September 10, 2026. The latest data from ClinicalTrials.gov was last updated on September 24, 2024.
Brief Summary
To evaluate the safety and initial effectiveness of human umbilical cord mesenchymal stem cells in HPV clearance.
Detailed Description
Cervical cancer is one of the most common malignant tumors of the female reproductive system with the highest incidence. Nearly 99.7% of cervical cancer is caused by HPV infection. Studies have shown that the persistent infection of high-risk human papillomavirus (HR-HPV) is an independent risk factor for cervical cancer which can lead to a 250-fold increased risk of high-grade cervical intraepithelial neoplasia (CIN...Show More
Official Title
Effectiveness and Safety of Human Umbilical Cord Mesenchymal Stem Cells for the Treatment of HPV High-risk Infection
Conditions
Human Papillomavirus VirusesMesenchymal Stem CellsOther Study IDs
- DFSC-2024(CR)-001
- HX-2021-007 (Other Grant/Funding Number) (Shanghai Shanghai East Hospital)
NCT ID Number
Start Date (Actual)
2024-03-01
Last Update Posted
2024-09-24
Completion Date (Estimated)
2026-09-10
Enrollment (Estimated)
60
Study Type
Interventional
PHASE
Phase 1
Phase 2
Phase 2
Status
Recruiting
Keywords
HPV
hUC-MSC
hUC-MSC
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalExperimental group 1×10\^6/Kg UC-MSCs (resuspended in 100 mL normal saline containing 5% albumin) are infused intravenously to the high-risk HPV persistant infected patients at a controlled rate of 60-80 drops/min | hUC-MSCs 1×10\^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. |
Placebo ComparatorControl group Normal saline containing 5% albumins are infused intravenously with an equal volume, similar suspension and appearance package as UC-MSCs to the high-risk HPV persistant infected patients at a controlled rate of 60-80 drops/min | Saline+albumin Normal saline containing 5% albumin had a similar suspension and appearance package to hUC-MSCs, but no MSCs |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | 1day,1st,4th,12th,and 36th week |
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. | -28th~0day,4th,12th,and 36th week |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | -28th~0day,1day,1st,4th,12th,and 36th week |
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. | -28th~0day,1day,1st,4th,12th,and 36th week |
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. | -28th~0day,1day,1st,4th,12th,and 36th week |
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 | -28th~0day,1day,1st,4th,12th,and 36th week |
The percentage of CD16+/CD56+ | The peripheral blood serum of the patients will be collected to detect the percentage（%） of CD16+/CD56+ 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. | -28th~0day,1day,1st,4th,12th,and 36th week |
The serum level of IFN-γ | The peripheral blood serum of the patients will be collected to detect the level of IFN-γ (pg/mL) before the infusion of hUC-MSCs (Any day from 28th to 1st day) and on the 1st day, 1st week, 12th week, and 36th week after the infusion. | -28th~0day,1day,1st,4th,12th,and 36th week |
The serum level of IL-6 | The peripheral blood serum of the patients will be collected to detect the level of IL-6 (pg/mL) before the infusion of hUC-MSCs (Any day from 28th to 1st day) and on the 1st day, 1st week, 4th week,12th week, and 36th week after the infusion. | -28th~0day,1day,1st,4th,12th,and 36th week |
The serum level of IL-8 | The peripheral blood serum of the patients will be collected to detect the level of IL-8 (pg/mL) before the infusion of hUC-MSCs (Any day from 28th to 1st day) and on the 1st day, 1st week, 4th week,12th week, and 36th week after the infusion. | -28th~0day,1day,1st,4th,12th,and 36th week |
The serum level of IL-10 | The peripheral blood serum of the patients will be collected to detect the level of IL-10 (pg/mL) before the infusion of hUC-MSCs (Any day from 28th to 1st day) and on the 1st day, 1st week, 4th week,12th week, and 36th week after the infusion. | -28th~0day,1day,1st,4th,12th,and 36th week |
The serum level of TNF-α | The peripheral blood serum of the patients will be collected to detect the level of TNF-α (pg/mL) before the infusion of hUC-MSCs (Any day from 28th to 1st day) and on the 1st day, 1st week, 12th week, and 36th week after the infusion. | -28th~0day,1day,1st,4th,12th,and 36th week |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult
Minimum Age
25 Years
Eligible Sexes
Female
- 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.
- 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.
Shanghai East HospitalStudy Central Contact
Contact: Jingjing Liu, M.D,.PH.D., 13795350828, [email protected]
1 Study Locations in 1 Countries
Shanghai Municipality
Shanghai Shanghai East Hospital, Tongji University School of Medicine, Shanghai, Shanghai Municipality, 200120, China
Fang Li, M.D.,PH.D., Contact, 13801986709, [email protected]
Fang Li, M.D.,PH.D., Contact
Zhongmin Liu, M.D.,PH.D., Contact
Recruiting