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A single-center, single-arm, open-label clinical study of placental gp96 injection to enhance immunity

A single-center, single-arm, open-label clinical study of placental gp96 injection to enhance immunity

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300072934
Enrollment
Unknown
Registered
2023-06-28
Start date
2023-06-01
Completion date
Unknown
Last updated
2023-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sub-healthy , low immunity people

Interventions

Sponsors

The First Affiliated Hospital of Hainan Medical University Lecheng Hospital (Ciming Boao International Hospita)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Age 18-70 years old, gender is not limited; (2) People with tissue hyperplasia such as nodules, polyps, cysts and lipomas in imaging indicators; (3) Abnormal increase of tumor markers in blood; (4) Have a history of chronic infection with HBV, HPV and other viruses; (5) chronic hepatitis B and/or cirrhosis of the liver; (6) People susceptible to seasonal infectious diseases such as influenza; (7) Sub-healthy people and people with low immunity; (8) Patients need to sign informed consent.

Exclusion criteria

Exclusion criteria: (1) Severe renal insufficiency: creatinine clearance 3 times the upper limit of normal value, or other known liver diseases such as acute and chronic active hepatitis, cirrhosis, etc.; (3) During the screening period, patients with heart failure who developed acute myocardial infarction or underwent interventional therapy within the last 6 months (III-IV patients according to NYHA classification); (4) Patients with other serious primary diseases of nervous system, heart, lung, hematopoietic system or endocrine system and mental illness; (5) Suspected or have a history of alcohol or drug abuse; (6) Pregnant women or breastfeeding women, subjects of reproductive age (including male subjects who have heterosexual sex and their female partners who have reproductive potential) from the beginning of screening to 3 months after the withdrawal of drugs have pregnancy plans or do not want to take effective contraceptive measures; (7) Have participated in other drug clinical trials within 30 days before screening, or are participating in other clinical trials; (8) The researcher considers it not suitable to participate in this experiment.

Design outcomes

Primary

MeasureTime frame
CBC;routine urine test ;blood biochemistry;ESR;CRP;ECG;

Secondary

MeasureTime frame
IFN-?+CD8+T;

Countries

China

Contacts

Public ContactHuang Yuyong

The First Affiliated Hospital of Hainan Medical University Lecheng Hospital

Huangyy0898@163.com+86 133 2209 3000

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026