HUC-MSC for Treatment of High-risk HPV Infection

NCT ID: NCT06610773

Last Updated: 2024-09-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2026-09-10

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). In patients with persistent HR-HPV infection for more than 12 months, the risk of diagnosis of high-grade squamous intraepithelial lesions of the cervix by 30 months increased to 21%. In the process of progression from HPV infection to cervical cancer, cervical precancerous lesions, namely intraepithelial neoplasia (CIN), will be experienced. Therefore, effective control of HPV infection, especially the elimination of persistent HR-HPV infection, will greatly reduce the incidence of CIN and cervical cancer. It is an urgent clinical need to actively intervene in patients with persistent infections for more than one year with a clinical significance at present.

Mesenchymal Stem Cells (MSCs) are a class of pluripotent stem cells derived from the mesoderm and ectoderm of early development, which can be easily obtained from a variety of tissue organs, having a strong proliferation and multidirectional differentiation potential in vitro. hUC-MSCs have a great effect on immune regulation and anti-inflammatory properties with a fewer ethical, availability, safety issues and a broader prospect in clinical research and application. At present, many experimental data have proved that MSCs can enhance the clearance of virus by immune cells in vivo, and have a certain application prospect in fighting virus infection. The purpose of this study was to evaluate the safety and therapeutic efficacy of human umbilical cord mesenchymal stem cells (HUC-MSCs) in clearing HPV infection, and to provide clinical basis for HUC-MSCs to clear HPV infection.

Conditions

Human Papillomavirus Viruses; Mesenchymal Stem Cells

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental 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

Group Type: EXPERIMENTAL

hUC-MSCs

Intervention Type: BIOLOGICAL

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.

Control 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

Group Type: PLACEBO_COMPARATOR

Saline+albumin

Intervention Type: BIOLOGICAL

Normal saline containing 5% albumin had a similar suspension and appearance package to hUC-MSCs, but no MSCs

Interventions

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.

Intervention Type: BIOLOGICAL

Saline+albumin

Normal saline containing 5% albumin had a similar suspension and appearance package to hUC-MSCs, but no MSCs

Intervention Type: BIOLOGICAL

Other Intervention Names

Umbilical Cord Mesenchymal Stem Cells

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Shanghai East Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fang Li, M.D,.PH.D.

Role: PRINCIPAL_INVESTIGATOR

Shanghai East Hospital, Shanghai Tongji University

Locations

Shanghai Shanghai East Hospital, Tongji University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jingjing Liu, M.D,.PH.D.

Role: CONTACT

liu.doctor@hotmail.com

13795350828

Facility Contacts

Fang Li, M.D.,PH.D.

Role: primary

fang_li@tongji.edu.cn

13801986709

Fang Li, M.D.,PH.D.

Role: backup

Zhongmin Liu, M.D.,PH.D.

Role: backup

Other Identifiers

HX-2021-007

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

DFSC-2024(CR)-001

Identifier Type: -

Identifier Source: org_study_id