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Mesenchymal Stem Cells

Regenerative Medicine for COVID-19 Related ARDS (RECOVER Trial)

Phase 1
Waitlist Available
Research Sponsored by Longeveron Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Confirmed diagnosis of infection with coronavirus or influenza virus
Diagnosis of mild to severe ARDS per the Berlin Definition of ARDS with specific conditions
Must not have
Prior positive test for Hepatitis B virus (HBV) surface antigen (HBsAg), viremic hepatitis C virus (HCV), Human immunodeficiency virus-1 or -2 (HIV1 or 2 HIV2), Human T-cell leukemia virus-I or -II (HTLV-I or HTLV-II), Syphilis without demonstration of resolution
Actively listing (or expected listing) for transplant of any organ, other than for corneal, bone, skin, ligament, or tendon transplant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 6 months

Summary

This trial is testing a new medication to see if it is safe for people with ARDS from either the COVID-19 or influenza virus.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects aren't detailed here as it's an early-phase trial focusing on safety, potential risks may include reactions at injection sites, immune responses like fever or chills, and possible allergic reactions due to DMSO sensitivity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with coronavirus or influenza.
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I have been diagnosed with ARDS ranging from mild to severe.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have tested positive for HBV, HCV, HIV, HTLV, or syphilis without resolution.
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I am on a transplant list for an organ other than cornea, bone, skin, ligament, or tendon.
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I am pregnant, nursing, or could become pregnant and am not using effective birth control.
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I have received an organ transplant, but it was not for corneal, bone, skin, ligament, or tendon.
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I have been on immunosuppressive drugs for more than 2 weeks in the last 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of Treatment-Emergent Serious Adverse Events
Number of Participants with Abnormal Clinical Significant Lab Values in the Blood Chemistry testing.
Number of Participants with Abnormal Clinical Significant Lab Values in the Coagulation.
+5 more
Secondary study objectives
Change in Imaging via Computerized Tomography
Change in Imaging via X-ray
Immunity

Trial Design

4Treatment groups
Active Control
Placebo Group
Group I: Cohort 2 (Flu): Arm 3 (LMSCs)Active Control1 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 Control1 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 Group1 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 Group1 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.

Find a Location

Who is running the clinical trial?

Longeveron Inc.Lead Sponsor
9 Previous Clinical Trials
413 Total Patients Enrolled

Media Library

Longeveron Mesenchymal Stem Cells (LMSCs) (Mesenchymal Stem Cells) Clinical Trial Eligibility Overview. Trial Name: NCT04629105 — Phase 1
Coronavirus Research Study Groups: Cohort 2 (Flu): Arm 4 (Placebo), Cohort 2 (Flu): Arm 3 (LMSCs), Cohort (SARS-CoV-2): Arm 2 (Placebo), Cohort 1 (SARS-CoV-2): Arm 1 (LMSCs)
Coronavirus Clinical Trial 2023: Longeveron Mesenchymal Stem Cells (LMSCs) Highlights & Side Effects. Trial Name: NCT04629105 — Phase 1
Longeveron Mesenchymal Stem Cells (LMSCs) (Mesenchymal Stem Cells) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04629105 — Phase 1
~13 spots leftby Dec 2025
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