HUC-MSC for Treatment of High-risk HPV Infection

NCT06610773 | Recruiting Phase 1 DMC

• 2 other identifiers: DFSC-2024(CR)-001HX-2021-007
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and initial effectiveness of human umbilical cord mesenchymal stem cells in HPV clearance.

Conditions

Human Papillomavirus Viruses; Mesenchymal Stem Cells

Keywords

HPV; hUC-MSC

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (10)

• The percentage of CD3+

  -28th~0day,1day,1st,4th,12th,and 36th week

• The percentage of CD4+

  -28th~0day,1day,1st,4th,12th,and 36th week

• The percentage of CD8+

  -28th~0day,1day,1st,4th,12th,and 36th week

• The percentage of CD19+

  -28th~0day,1day,1st,4th,12th,and 36th week

• The percentage of CD16+/CD56+

  -28th~0day,1day,1st,4th,12th,and 36th week

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Biological: hUC-MSCs

Control group

PLACEBO COMPARATOR

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

Biological: Saline+albumin

Interventions

hUC-MSCs 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.

Also known as: Umbilical Cord Mesenchymal Stem Cells

Experimental group

Saline+albumin BIOLOGICAL

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

Control group

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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;

Sponsors & Collaborators

• Shanghai East Hospital: lead

Study Sites (1)

Shanghai Shanghai East Hospital, Tongji University School of Medicine

Shanghai, Shanghai Municipality, 200120, China

RECRUITING

Study Officials

• Fang Li, M.D,.PH.D.

  Shanghai East Hospital, Shanghai Tongji University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

13795350828; liu.doctor@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2024
• First Posted: September 24, 2024
• Study Start: March 1, 2024
• Primary Completion: September 10, 2025
• Study Completion (Estimated): September 10, 2026
• Last Updated: September 24, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)