Regenerative Medicine for COVID-19 Related ARDS

(RECOVER Trial)

Recruiting at 2 trial locations

Overseen By Kevin N Ramdas, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Longeveron Inc.

Must not be taking: Immunosuppressants

Disqualifiers: ECMO, Malignancy, HIV, others

Compensation: Varies

Number of Visits: 7

Duration: 1 week

70 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications. However, continuous use of any medication at immunosuppressive dosing for more than 14 consecutive days in the past 3 months is not allowed. Some medications like hydroxychloroquine, remdesivir, lopinavir/ritonavir, and ivermectin are permitted.

What data supports the effectiveness of the treatment Longeveron Mesenchymal Stem Cells (LMSCs) for COVID-19 Related ARDS?

Research suggests that mesenchymal stem cells (MSCs), similar to Longeveron Mesenchymal Stem Cells, can help reduce inflammation and improve lung function in patients with COVID-19-related acute respiratory distress syndrome (ARDS). Studies have shown that MSCs can decrease inflammatory markers and stabilize lung function, potentially aiding in recovery without serious side effects. ^{1 2 3 4 5}

Is the regenerative medicine treatment using mesenchymal stem cells safe for humans?

Research indicates that mesenchymal stem cell treatments, including those derived from bone marrow and umbilical cord, are generally safe for humans, with no significant adverse events reported in studies involving COVID-19-related ARDS patients. ^{3 6 7 8 9}

How is the treatment Longeveron Mesenchymal Stem Cells (LMSCs) unique for COVID-19-related ARDS?

Longeveron Mesenchymal Stem Cells (LMSCs) are unique because they are derived from umbilical cord tissue and have the ability to modulate the immune response and reduce inflammation, which can help repair lung damage in COVID-19-related ARDS. Unlike traditional treatments, LMSCs are administered intravenously and focus on reducing the cytokine storm, a severe immune reaction, to improve lung function and patient outcomes. ^{1 2 3 4 5}

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive up to 3 doses of 100 million Lomecel-B or placebo on Days 0, 3, and 6

1 week

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Daily visits until hospital discharge, then at Week 4 and Month 6

Treatment Details

Interventions

• Longeveron Mesenchymal Stem Cells (LMSCs)

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+

References

1. England pubmed.ncbi.nlm.nih.gov

Cell-based therapy to reduce mortality from COVID-19: Systematic review and meta-analysis of human studies on acute respiratory distress syndrome. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Feasibility Study of Cord Tissue Derived Mesenchymal Stromal Cells in COVID-19-Related Acute Respiratory Distress Syndrome. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Mesenchymal stem cells derived from perinatal tissues for treatment of critically ill COVID-19-induced ARDS patients: a case series. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Mesenchymal stromal cell therapy for COVID-19-induced ARDS patients: a successful phase 1, control-placebo group, clinical trial. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Intravenous Administration of Umbilical Cord-Derived Mesenchymal Stem Cells (UC-MSC) for Acute Respiratory Distress Syndrome Due to COVID-19 Infection. [2023]

6. England pubmed.ncbi.nlm.nih.gov

The safety and efficacy of mesenchymal stromal cells in ARDS: a meta-analysis of randomized controlled trials. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Human mesenchymal stem cell therapy in severe COVID-19 patients: 2-year follow-up results of a randomized, double-blind, placebo-controlled trial. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness of Mesenchymal Stem Cell Therapy for COVID-19-Induced ARDS Patients: A Case Report. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Mesenchymal Stem Cells for the Compassionate Treatment of Severe Acute Respiratory Distress Syndrome Due to COVID 19. [2021]