Regenerative Medicine for COVID-19 Related ARDS

(RECOVER Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Longeveron Mesenchymal Stem Cells (LMSCs) to determine its safety for individuals with acute respiratory distress syndrome (ARDS) caused by COVID-19 or the flu. The trial divides participants into groups receiving either the stem cell treatment or a placebo (a substance with no active treatment). Those diagnosed with ARDS and currently battling COVID-19 or the flu might be suitable candidates for this study. Participants must agree to various assessments and blood sample collections throughout the study. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that Longeveron Mesenchymal Stem Cells (LMSCs) are likely to be safe for humans?

Research shows that Longeveron Mesenchymal Stem Cells (LMSCs) are under investigation as a potential treatment for severe lung problems caused by COVID-19 and the flu. Studies have found that treatments like LMSCs have not led to serious side effects, such as low oxygen levels or irregular heartbeats, in patients with these lung issues. This suggests that LMSCs might be safe for use.

At this early stage, the primary goal is to determine the safety of LMSCs for people. While detailed results from ongoing studies are not yet available, earlier data on similar treatments appear promising. It is important to remember that these findings are still undergoing testing to ensure safety and effectiveness. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for ARDS?

Unlike standard treatments for acute respiratory distress syndrome (ARDS), which often include mechanical ventilation and supportive care, Longeveron Mesenchymal Stem Cells (LMSCs) offer a novel approach by potentially reducing inflammation and repairing damaged lung tissue. Researchers are excited about LMSCs because they harness the body's natural healing processes, utilizing stem cells to target and repair inflammation at the cellular level. This could lead to improved outcomes for patients with ARDS related to COVID-19 or the flu, offering a regenerative solution rather than just managing symptoms.

What evidence suggests that Longeveron Mesenchymal Stem Cells might be an effective treatment for ARDS?

Research shows that Longeveron Mesenchymal Stem Cells (LMSCs) might help treat severe lung problems caused by COVID-19. In this trial, some participants will receive LMSCs. Studies have noticed improvements in lung function and X-ray results in patients treated with similar therapies. Specifically, patients receiving these treatments demonstrated better lung flexibility, allowing their lungs to expand more easily. Improvements in the PaO2/FiO2 ratio, which measures oxygen levels in the blood, also indicate better lung performance. Although more research is needed, these early findings suggest LMSCs could aid recovery from severe COVID-19 lung issues. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7300743/

Cell‐based therapy to reduce mortality from COVID‐19 A trend was found of improved radiographic findings, pulmonary function (lung compliance, tidal volumes, PaO2/FiO2 ratio, alveolo‐capillary injury), and ...

2. longeveron.com longeveron.com/clinical-trials/

Clinical Trials Primary Outcome Measures:​​ Safety: Incidence of treatment-emergent serious adverse events (TE-SAEs) within 4 weeks after treatment. Efficacy: Time to recovery ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2352320424000476

Potential therapeutic effects and nano-based delivery ... Clinical studies have shown that MSCs and their derivatives, such as exosomes and microvesicles, can be effective in the treatment of COVID-19-related ARDS ...

4. researchgate.net researchgate.net/publication/363582087_Mesenchymal_Stem_Cell_Therapy_and_COVID-19

(PDF) Mesenchymal Stem Cell Therapy and COVID-19 ... Syndrome Due to. COVID 19. Recruiting No Results. Available. • Acute. Respiratory. Distress. Syndrome. • Drug: Wharton's jelly derived.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04416139?term=mesenchymal%20stem%20cells&cond=Covid19&aggFilters=status:&viewType=Table&rank=3

Mesenchymal Stem Cell for Acute Respiratory Distress ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8858603/

Mesenchymal stem cell-based treatments for COVID-19 used allogeneic MSCs in patients with acute respiratory distress syndrome (ARDS) and found no adverse reactions, such as hypoxemia, arrhythmia, and ventricular ...