The birth of AIDS therapeutic apparatus

Time of project approval: 2003

Purpose of project approval: blood transfusion safety in the field, temporary blood transfusion safety in wartime as well as prevention and control of window period and missed detection.

National 863 Program

Project title: Study on plasma viral inactivation device (Project No.: 2003AA208307).

Military "Tenth Five-Year Plan" mandatory project

Project title: Study on rapid blood test and virus inactivation method and equipment (Project No.: 01L041).

Treatment process and principle of AIDS therapeutic apparatus

Principles

The free virus in the separated plasma of the patient is collected through the AIDS therapeutic apparatus, and then inactivated and reinfused. The amount of live viruses in the blood is directly reduced (viral load is decreased). It immediately relieves the pressure of the immune system in the patient and provides a valuable time window for the reconstruction of the patient's immune system; it destroys the core genetic material (nucleic acid RNA) of HIV virus in the plasma, thus avoiding the possibility of drug resistance; through the collection of virus in the plasma, it obtains the sample information containing all the mutant viruses. The HIV nucleic acid inactivated by the AIDS therapeutic apparatus also retains the complete immunogenicity of the virus, and the large dose of virus with preserved immunogenicity is directly prepare into autologous holographic vaccine. The clinical therapeutic effect is achieved by combining a large dose of plasma that retains immunogenic virus with immune cells in the body to generate an immune response .

Efficacy experiments

Milestone event: In Vitro HIV inactivation verification trial of BX-I AIDS therapeutic apparatus

Laboratory: State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, Zhejiang University (National P3 Laboratory)

Experimental instrument: Boxin BX-I AIDS Therapeutic Apparatus

Objective: To verify the virus inactivation effect of BX-I AIDS therapeutic apparatus with HIV virus

Experiment rationale: Guidelines on the Viral Removal/ Virus Inactivation Procedures of Blood Products and Validation.

Date of experiment: September, 2019


Results

BX-I AIDS therapeutic apparatus can effectively inactivate the verified HIV-1 indicator virus after irradiating virus plasma containing 1 mol/L methylene blue for 2 min at 630nm single wavelength. After irradiation for 2 min, 5 min, 10 min, 20 min and 40 min, the amount of virus reduction is ≥ 5.17-5.67 Lg TCID50. Plasma samples irradiated for 40 min are added with sensitive cells for three blind passages, and no virus is detected. The results of this validation trial show that the BX-I AIDS therapeutic apparatus is effective for the in vitro inactivation of the selected HIV-1 indicator virus.

Effectiveness of in vitro HIV-1 inactivation by BX-I AIDS Therapeutic Apparatus


Detection of HIV-1 pNL (AD8) virus titer in different treatment groups


The industry standard for plasma virus inactivation in China has been developed and the Medical Device Registration Certificate has been approved


Acceptance inspection by expert group and recognition of achievements by the Ministry of Science and Technology

In June 2018, AIDS therapeutic apparatus and supporting therapies passed the acceptance by the expert group

Members of expert team: Prof. Li Xingwang from Beijing Ditan Hospital, Prof. Zhao Min from the 302 Hospital of PLA and Prof. Zhang Tong from Beijing YouAn Hospital

The expert panel agreed that the Autologous Immune System Reconstitution Therapy for AIDS "has good immunological and virological effects, and is safe and well tolerated. Compared with traditional antiviral drug therapy, this regimen is unique, innovative and feasible, with obvious social benefits"

The Certificate of Scientific and Technological Achievements of Ministry of Industry and Information Technology was obtained in June 2018


The patent for invention is obtained and the patent is extended in key countries and regions