Autologous Adipose-derived Stem Cells (AdMSCs) for COVID-19

ConditionCOVID-19
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCelltex Therapeutics Corporation

About this trial

This is a phase 2 multi-center, double-blind, randomized, placebo-control clinical trial with 200 subjects who have never been infected by COVID-19 (SARS-Cov-2 virus screen test negative, no blood SARS-Cov-2 IgM and IgG antibodies detected during enrollment) followed by a pilot study of 5 subjects to demonstrate the safety of proposed three-dose regimen of autologous AdMSCs infusions. The 100 study subjects who have previously banked their AdMSCs with Celltex, will receive three doses of autologous AdMSCs (approximately 200 million cells) intravenous infusion every three days. The 100 subjects in the control group who have previously banked their AdMSCs with Celltex will not receive any Celltex's AdMSC therapy but placebo treatments. All subjects are monitored for safety (adverse events/severe adverse events), COVID-19 symptoms, SARS-Cov-2 virus test, blood SARS-Cov-2 IgM and IgG antibodies tests, blood cytokine and inflammatory (CRP, IL\_6, IL-10, TNFα) tests and disease severity evaluation for 6 months after the last dose of AdMSC infusion for the study group and 6 months after the enrollment for the control group.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age above 18 years.

Male or female

Subjects should have banked AdMSCs in Celltex (already passed communicable disease screen tests for HIV, syphilis, Hepatitis B and C during banking stage)

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

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

Blood test for SARS-Cov-2 antibodies IgM and IgG positive

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • autologous adipose-derived stem cells

    Biological/Vaccine

    Culture expanded mesenchymal stem cells isolated from a patient's own abdominal fat tissue

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Phase 2 AdMSC groupExperimental treatment 1 intervention
Group B: Phase 2 Placebo groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Tolerability and acute safety of AdMSC infusion by assessment of the total number of AEs/SAEs related and non-related with the medication

adverse events and severe adverse events

Time frame
6 months
2

The overall proportion of subjects who develop any AEs/SAEs related and non-related with the AdMSC infusions as compared to the control group

adverse events and severe adverse events

Time frame
6 months
3

COVID-19 incidence rates in both the study and control groups

efficacy

Time frame
6 months

Secondary outcomes

1

The proportion of subjects who are infected by SARS-Cov-2 measured by PCR or other nuclear level-based SARS-Cov-2 virus testing in respiratory tract specimens (oropharyngeal samples) collected by oropharyngeal swab using the CDC standard method.

efficacy

Time frame
6 months
2

The proportion of subjects who are infected by SARS-Cov-2 virus develop symptoms including mild, classic, severe and critical sever cases between study group and control group.

efficacy

Time frame
6 months
3

Change of proportion of subjects who are infected by SARS-Cov-2 and develop IgM/IgG antibodies against SARS-Cov-2 between study group and control group.

efficacy

Time frame
6 months
4

Change of lymphocyte count in white blood cell counts from the baseline

efficacy

Time frame
6 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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