Clinical Study for Subjects With COVID-19 Using Allogeneic Adipose Tissue-Derived Mesenchymal Stem Cells

ConditionsCorona Virus Infection Covid19

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorCelltex Therapeutics Corporation

About this trial

This is an interventional new drug clinical trial for a Phase 2 randomized, double-blind, and placebo control study using intravenous injection of allogeneic adipose stem cells (Celltex AdMSCs) for subjects with severe COVID-19.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age above 18 years.

Male and female

Must understand and voluntarily sign an Informed Consent for study participation obtained prior to undergoing any study-specific procedures

Diagnosed as COVID-19 based upon SARS-CoV-2 RT-PCR test positive

Disqualifiers

Participation in another clinical study (with use of another Investigational Medical Product) within 3 months prior to study treatment start

Unwillingness or inability to comply with study procedures

Patients with serious basic diseases that affect survival, including blood diseases, cachexia, active bleeding, severe malnutrition, etc.

Clinically active malignant disease

Trial design

Design model

Parallel

Treatments tested in this trial

Allogeneic adipose-derived stem cells
Biological/Vaccine
Culture expanded mesenchymal stem cells isolated from a patient's own abdominal fat tissue

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: Study GroupExperimental treatment 1 intervention

Group B: Control GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Safety of AdMSC injection will be evaluated by assessment of the frequency and nature of adverse events occurring during the study based on the rate of all AdMSC-associated adverse events (AEs) in all subjects.

Incidence of treatment-related adverse events and severe adverse events during the study period

Time frame

6 months

Safety for AdMSCs based upon incidence of all AEs

Grouped by Medical Dictionary for Regulatory Activities (MedDRA)

Time frame

6 months

Compare the mortality rate

AdMSC treating group vs. control group

Time frame

6 months

Secondary outcomes

Recognized immune measurements evaluating patients' symptom changes and overall function

To evaluate change of sequential organ failure assessment (SOFA) score as compare to the baseline

Time frame

6 months

Organ functional tests including blood specific enzymes and proteins

To evaluate the efficacy of allogeneic AdMSCs for COVID-19

Time frame

6 months

Duration (days) of weaning from mechanical ventilation

Compared to control group

Time frame

6 months

Duration (days) of ICU monitoring

Compared to control group

Time frame

6 months

Other outcomes

Mortality rate down to 0%

For severe and critical cases

Time frame

6 months

Achieve at least 30% more proportion of severe patients in AdMSC study group without developing organ failure or recovery from previous organ failure

Compared to control group

Time frame

6 months

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Celltex Therapeutics Corporation

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: