Human Papillomavirus VirusesPhase 1/2NCT06610773
HUC-MSC for Treatment of High-risk HPV Infection
A Phase 1/2 study testing hUC-MSCs and Saline+albumin in people with Human Papillomavirus Viruses and Mesenchymal Stem Cells, run by Shanghai East Hospital at 1 site in China.
Trial summary
To evaluate the safety and initial effectiveness of human umbilical cord mesenchymal stem cells in HPV clearance. Read more about this study
- Who is it for?
- Ages 25 to 60 years, women only
- Conditions the study is for
- Human Papillomavirus Viruses, Mesenchymal Stem Cells
- What is being tested?
- hUC-MSCs and Saline+albumin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 10 Sep 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Shanghai East Hospital, Tongji University School of Medicine
Shanghai, Shanghai Municipality, 200120
Fang Li, M.D.,PH.D., 13801986709, fang_li@tongji.edu.cn
Fang Li, M.D.,PH.D.
About this study
Official title: Effectiveness and Safety of Human Umbilical Cord Mesenchymal Stem Cells for the Treatment of HPV High-risk Infection
To evaluate the safety and initial effectiveness of human umbilical cord mesenchymal stem cells in HPV clearance.
Read the 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.
- Being tested
- hUC-MSCs, Saline+albumin
- Keywords
- HPV, hUC-MSC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hUC-MSCsBiological
Also called Umbilical Cord Mesenchymal Stem Cells
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.
Saline+albuminBiological
Normal saline containing 5% albumin had a similar suspension and appearance package to hUC-MSCs, but no MSCs
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Biological: Saline+albumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: -28th~0day,4th,12th,and 36th week
Secondary outcomes (10)
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.
Measured: -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.
Measured: -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.
Measured: -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
Measured: -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.
Measured: -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.
Measured: -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.
Measured: -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.
Measured: -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.
Measured: -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.
Measured: -28th~0day,1day,1st,4th,12th,and 36th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start1 Mar 2024
- Primary completion10 Sep 2025 (estimated)
- Study completion10 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papillomavirus VirusesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai East Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fang Li, M.D,.PH.D., Principal investigator, Shanghai East Hospital, Shanghai Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06610773
- Sponsor's protocol ID
- DFSC-2024(CR)-001
- Other IDs
- HX-2021-007
- Status last verified
- Sep 2024
- First submitted
- 28 Aug 2024
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Human Umbilical Cord Mesenchymal Stem Cells for the Treatment of HPV High-risk Infection
- ClinicalTrials.gov ID
- NCT06610773
- Acronym / sponsor ID
- DFSC-2024(CR)-001
- Keywords
- HPV, hUC-MSC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai East HospitalUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 10 Sep 2025 (estimated)
- Study completion
- 10 Sep 2026 (estimated)
- First posted
- 24 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Biological: hUC-MSCs1×10^6/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 |
| Control group | Placebo comparator | Biological: Saline+albuminNormal 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 |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hUC-MSCsAlso: Umbilical Cord Mesenchymal Stem Cells1×10^6/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. | Biological | Experimental group |
| Saline+albuminNormal saline containing 5% albumin had a similar suspension and appearance package to hUC-MSCs, but no MSCs | Biological | Control group |
Primary outcome
Adverse events-The incidence rate of allergic reaction
Time frame: 1day,1st,4th,12th,and 36th week
The allergic reaction rate on the 1st day, 1st week, 4th week, 12th week, and 36th week after the infusion.
The 24 type HPV viral load
Time frame: -28th~0day,4th,12th,and 36th week
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.
10 secondary outcomes
The percentage of CD3+
Time frame: -28th~0day,1day,1st,4th,12th,and 36th week
The percentage of CD4+
Time frame: -28th~0day,1day,1st,4th,12th,and 36th week
The percentage of CD8+
Time frame: -28th~0day,1day,1st,4th,12th,and 36th week
The percentage of CD19+
Time frame: -28th~0day,1day,1st,4th,12th,and 36th week
The percentage of CD16+/CD56+
Time frame: -28th~0day,1day,1st,4th,12th,and 36th week
The serum level of IFN-γ
Time frame: -28th~0day,1day,1st,4th,12th,and 36th week
The serum level of IL-6
Time frame: -28th~0day,1day,1st,4th,12th,and 36th week
The serum level of IL-8
Time frame: -28th~0day,1day,1st,4th,12th,and 36th week
The serum level of IL-10
Time frame: -28th~0day,1day,1st,4th,12th,and 36th week
The serum level of TNF-α
Time frame: -28th~0day,1day,1st,4th,12th,and 36th week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fang Li, M.D,.PH.D. principal investigator
Shanghai East Hospital, Shanghai Tongji University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing hUC-MSCs and Saline+albumin in people with Human Papillomavirus Viruses and Mesenchymal Stem Cells, run by Shanghai East Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jingjing Liu, M.D,.PH.D. (13795350828, liu.doctor@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events-The incidence rate of allergic reaction (time frame: 1day,1st,4th,12th,and 36th week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2024; AzTrials last refreshed its copy on 7 Nov 2026.