Study to Evaluate the Efficacy and Safety of AstroStem-V in Treatment of COVID-19 Pneumonia

NCT04527224 | Unknown Phase 1 FDA Drug

• 1 other identifier: ASVP1N2A-US
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

This study is an open-label, single-arm study to evaluate the safety and efficacy of Astrostem-V, allogenic adipose tissue derived mesenchymal stem cells (AdMSC), in patients with COVID-19 pneumonia. After each subject completes 12-Weeks visit (Visit 12) and the data management team confirms all individual data have no issue, the individual database will be locked and the blinding will be open for the statistical analysis.

Conditions

Covid19 Pneumonia

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse events

  Number of subjects with treatment related adverse events as assessed by analysis of adverse events including symptoms.

  From baseline to Week 12

• Abnormalities of physical examination, vital signs, and laboratory test

  Number of subjects with treatment related adverse events as assessed by analysis of adverse events including abnormal findings on physical examination, vital signs, ECG, and standard laboratory examination.

  From baseline to Week 12

Secondary Outcomes (6)

• SpO2

  From baseline to Week 12

• Mortality rate

  Week 4, Week 8, and Week 12

• Ventilator treatment status

  From Week 1 to Week 12

• Improvement of pneumonia assessed by radiologic examination(Chest X-ray or CT)

  From baseline to Week 12

• SOFA score (Sequential Organ Failure Assessment)

  From baseline to Week 12

Study Arms (1)

AstroStem-V

EXPERIMENTAL

AstroStem-V which consists of three syringes and each syringe contains 1.0 x 10\^8 cells / 3mL of saline with 30% human serum

Drug: AstroStem-V

Interventions

AstroStem-V DRUG

Allogenic adipose tissue-derived mesenchymal stem cells (AdMSCs)

AstroStem-V

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 19 to 80 years at the time of signing the written consent form
• Subjects diagnosed with pneumonia by radiologic examination (Chest X-ray or CT) at screening and baseline
• subject who has moderate COVID-19 disease:
• Subjects have laboratory-confirmed SARS-CoV-2 infection within 28 days from screening by authorized a reverse-transcription polymerase chain reaction (RT-PCR) or equivalent testing at baseline
• A subject who has symptoms of moderate illness with COVID-19, which could include any symptom of mild illness or shortness of breath with exertion
• A subject who has clinical signs suggestive of moderate illness with COVID-19, such as respiratory rate ≤ 20 breaths per minute, SpO2 ≥ 93% on room air at sea level, heart rate ≤ 90 beats per minute
• No clinical signs indicative of severe COVID-19 disease severity
• Subjects voluntarily participate in the clinical trial with written informed consent

You may not qualify if:

• Subjects who have pulmonary disease except COVID-19 pneumonia
• SpO2 ≤ 93%
• Subjects who have uncontrolled shock
• Subjects diagnosed with COVID-19 with CPR or requires treatment of Extra Corporeal Membrane Oxygenation (ECMO)
• Subjects with an irreversible brain lesion or medical history of malignant tumors
• Subjects treated for heart disease within 3 months prior to screening
• Subjects who are receiving immunosuppressant therapy for transplantation or who are taking immunosuppressive drugs such as steroids, TNF-alpha inhibitors
• Subject treated with stem cells.
• Subjects with end-stage renal failure who need renal replacement therapy or cirrhosis patients with complications
• Subjects who have an average life expectancy to be less than 2 months due to the underlying disease
• Subjects who have history of thromboembolism or pulmonary arterial hypertension
• Subjects who currently have positive HIV test results
• Pregnant or breast-feeding women
• Subjects with pregnancy planned during clinical trials. Women or men of childbearing age who do not agree to maintain contraception by choosing, or who do not agree to use the appropriate method of contraception
• suitable contraceptive methods: condom, sponge, foam, gel, diaphragm for contraception, intrauterine device, etc. Periodic abstinence (eg, calendar method, ovulation method, symptom body temperature method, post ovulation method) and restraint is not considered an accepted method of contraception, and hormonal contraceptives are not allowed. However, women having no potential are pregnancy due to menopause (amenorrhea more than 12 months after the last menstruation) or surgical infertility is possible to participate in the study only the pregnancy test is negative

Sponsors & Collaborators

• Nature Cell Co. Ltd.: lead

Study Sites (2)

Medical Advancement Center of Arizona

Phoenix, Arizona, 85283, United States

RECRUITING

Epic Medical Research

Dallas, Texas, 75154, United States

RECRUITING

Study Officials

• JeongChan Ra, Ph.D.

  Nature Cell Co. Ltd.

  STUDY DIRECTOR

Central Study Contacts

Hugh Lee

CONTACT

301-540-260; hughlee@kcrnresearch.com

Jane Shin

CONTACT

213-797-2655; jane.shin@stemcellbio.us

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2020
• First Posted: August 26, 2020
• Study Start: October 24, 2022
• Primary Completion: November 1, 2023
• Study Completion: December 1, 2023
• Last Updated: January 10, 2023

Record last verified: 2023-01

Locations

US (2)