Regenerative Medicine for COVID-19 Related ARDS

(RECOVER Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Longeveron Inc.

Trial Summary

What is the purpose of this trial?

A Phase I, double- blinded, randomized, placebo- controlled study to test the safety of Lomecel-B in Adults suffering from mild to severe acute respiratory distress syndrome (ARDS) due to COVID-19 resultant from 2019-nCoV coronavirus infection, or resultant from influenza virus infection.

Research Team

Eligibility Criteria

Adults with mild to severe ARDS due to COVID-19 or flu, who can consent (or have a legal rep consent), are willing to follow study procedures and allow their samples to be used for research. Excluded if on other trials recently, have certain infections like HIV/HBV/HCV/HTLV/syphilis, serious illnesses, cancer in the last 2.5 years (with exceptions), pregnant/nursing women not using contraception, listed for organ transplant (except minor ones) or on immunosuppressants.

Inclusion Criteria

My gender or race does not limit my participation.

I agree to let my samples be stored for future research.

I have been diagnosed with coronavirus or influenza.

Exclusion Criteria

I haven't had cancer in the last 2.5 years, except for certain skin or cervical cancers treated with the intent to cure.

I have tested positive for HBV, HCV, HIV, HTLV, or syphilis without resolution.

I am on a transplant list for an organ other than cornea, bone, skin, ligament, or tendon.

Treatment Details

Interventions

• Longeveron Mesenchymal Stem Cells (LMSCs) (Mesenchymal Stem Cells)

Trial Overview The trial is testing Lomecel-B made from stem cells against a placebo in adults with ARDS caused by COVID-19 or influenza. It's Phase I, meaning early-stage research focused on safety. Participants are randomly assigned to receive either the stem cell treatment or a placebo without knowing which one they get.

Participant Groups

Group I: Cohort 2 (Flu): Arm 3 (LMSCs) Active Control 1 Intervention

Cohort 2: Subjects with ARDS and acutely infected with influenza virus. Arm 3: 25 subjects treated with up to 3 doses of 100 million LMSCs.

Group II: Cohort 1 (SARS-CoV-2): Arm 1 (LMSCs) Active Control 1 Intervention

Cohort 1: Subjects with ARDS and acutely infected with SARS-CoV-2. Arm 1: 25 subjects treated with up to 3 doses of 100 million LMSCs.

Group III: Cohort 2 (Flu): Arm 4 (Placebo) Placebo Group 1 Intervention

Cohort 2: Subjects with ARDS and acutely infected with influenza virus. Arm 4: 10 subjects treated with up to 3 doses of Placebo.

Group IV: Cohort (SARS-CoV-2): Arm 2 (Placebo) Placebo Group 1 Intervention

Cohort 1: Subjects with ARDS and acutely infected with SARS-CoV-2. Arm 2: 10 subjects treated with up to 3 doses of Placebo.

Who Is Running the Clinical Trial?

Longeveron Inc.

Lead Sponsor

Trials

10

Recruited

480+