HUMSCs and Exosomes Treating Patients with Lung Injury following Novel Coronavirus Pneumonia (COVID-19)

• Register: ChiCTR
• Last refreshed on: 9 March 2020
• Main ID: ChiCTR2000030484
• Date of registration: 2020-03-03
• Prospective Registration: No
• Primary sponsor: Hubei Shiyan Taihe hospital
• Public title: HUMSCs and Exosomes Treating Patients with Lung Injury following Novel Coronavirus Pneumonia (COVID-19)
• Scientific title: HUMSCs and Exosomes Treating Patients with Lung Injury following Novel Coronavirus Pneumonia (COVID-19)
• Date of first enrolment: 2020-02-02
• Target sample size: treatment group1:30;treatment group 2:30;control group:30;
• Recruitment status: Pending
• URL: http://www.chictr.org.cn/showproj.aspx?proj=50263
• Study type: Interventional study
• Study design: Parallel
• Phase: N/A

Countries of recruitment

China

Contacts

• Name: Jianjun Li
• Affiliation: Beijing Darwin Cell Biotechnology Co., Ltd

• Name: Jie Luo
• Affiliation: Shiyan Taihe hospital

Key inclusion & exclusion criteria

Inclusion criteria: (1) The novel coronavirus was detected at the age of 18~70 years when signing the informed consent; (2) the nucleic acid test of the pharyngeal test, sputum, lower respiratory tract secretions, blood and so on (RT-PCR detection of the new coronavirus nucleic acid positive) and the sequencing of the virus gene, which were highly homologous with the known new coronavirus, and confirmed that the 2019-nCoV was detected. Chest X * ray and CT imaging confirmed pneumonia (manifested as pulmonary infiltration, single lung or multiple lung lesions, mainly located in the lung field and subpleural area of the Chinese and foreign countries. Lesions were presented as "mosaic" sign caused by small patch glass, consolidation and coexistence of small nodules, ground glass shadow and air retention). Lung imaging showed significant progress in 24-48 hours. The patients had no improvement or progressive aggravation after standard anti bacteria treatment; ? had fever, fatigue, cough, shortness of breath and other symptoms, because of fever (body temperature = 37.3 ?), respiratory rate > 30 times / min, SpO2 = 93% (quiet, resting state), oxygenation index = 300; ? The total number of leukocytes in the early stage of onset was normal / decreased, or lymphocyte count decreased. C reactive protein and ESR increased, PCT was normal. (6) epidemiological history (two weeks before onset, Hubei or other higher incidence rate of travel history, or contact with persons from above regions, or the removal of other suspected and confirmed cases), the time from onset to less than 14 days. The subjects are willing to be randomly assigned to any designated treatment group; ? on the basis of current routine treatment, the patients are still in progress, fully informed and signed with the patients and their families; ? they must agree not to participate in another study of the drug under study before the 28th day after the completion of the study.
Exclusion criteria: ? Doctors decided that it was not in the best interests of the subjects to participate in the study, or there was any situation that could not follow the agreement safely; ? there was a history of pulmonary embolism; ? there were patients with human immunodeficiency virus (HIV) infection; ? there were severe organ failure; such as severe liver disease (such as child Pugh score = grade C, AST more than 5 times of the upper limit of normal; or severe renal insufficiency (estimated glomerular filtration rate = 30ml / min / 1.73m2) or patients undergoing continuous renal replacement therapy, hemodialysis, peritoneal dialysis; severe shock or other situations that clinicians think are not suitable for use. (Note: due to the newly discovered disease, clinicians can't give up the hope of treatment at will based on the principle of rescuing the dead and supporting the wounded) ? pregnant and lactating women, or positive pregnancy test before medication; ? human immunodeficiency virus (HIV) infected patients; ? Patients with malignant tumors, except those with cervical carcinoma in situ, skin non metastatic squamous or basal cell carcinoma who have been treated completely; ? any experimental treatment for lung injured cells or stem cells within 28 days before screening and evaluation.

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Lung injury

Intervention(s)

treatment group1:HUMSCs: intravenous infusion, 5 × 10E7 cells / time, once / week, twice / course;treatment group 2:HUMSCs: intravenous infusion, 5 × 107 cells / time, 1 time / week, 2 times / course, a total of 2 courses; Exosomes: intravenous administration, 180mg / time, 1 time / day, 7 days / course, 2 courses in total;control group:The control group was given the same amount of placebo (stem cell solvent);

Primary Outcome(s)

PaO2 / FiO2 or respiratory rate (without oxygen);Frequency of respiratory exacerbation;Observe physical signs and symptoms and record clinical recovery time;The number and range of lesions indicated by CT and X-ray of lung;Time for cough to become mild or absent;Time for dyspnea to become mild or no dyspnea;Frequency of oxygen inhalation or noninvasive ventilation, frequency of mechanical ventilation;Inflammatory cytokines (CRP / PCT / SAA, etc.);Frequency of serious adverse events;

Source(s) of Monetary Support

Beijing Darwin Cell Biotechnology Co., Ltd

Ethics review

Status: Approved
Approval date:
Contact:

Gang Jian