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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 6 months
Awards & highlights
RECOVER Trial 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.Check my eligibility
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.See study design
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.
RECOVER Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with coronavirus or influenza.
Select...
I have been diagnosed with ARDS ranging from mild to severe.
Select...
I am 18 years old or older.
RECOVER Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreSecondary outcome measures
Change in Imaging via Computerized Tomography
Change in Imaging via X-ray
Immunity
RECOVER 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
Eligibility Criteria:
This trial includes the following eligibility 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.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.I am not currently in a clinical trial and haven't been in one for the last 30 days.I have given or my legal representative has given written consent.I have been diagnosed with ARDS ranging from mild to severe.I am 18 years old or older.My gender, race, or ethnicity does not limit my participation.You are currently using a machine called Extracorporeal Membrane Oxygenation (ECMO).You are allergic to dimethyl sulfoxide (DMSO).I am pregnant, nursing, or could become pregnant and am not using effective birth control.I have received an organ transplant, but it was not for corneal, bone, skin, ligament, or tendon.I have been on immunosuppressive drugs for more than 2 weeks in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 2 (Flu): Arm 4 (Placebo)
- Group 2: Cohort 2 (Flu): Arm 3 (LMSCs)
- Group 3: Cohort (SARS-CoV-2): Arm 2 (Placebo)
- Group 4: Cohort 1 (SARS-CoV-2): Arm 1 (LMSCs)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the FDA regulating Cohort 2 (Flu): Arm 3 (LMSCs)?
"Our research group at Power has assigned Cohort 2 (Flu): Arm 3 (LMSCs) a score of 1 as it is within the realm of Phase 1 trials, which necessitate limited evidence concerning safety and efficacy."
Answered by AI
Are there available vacancies for participants in this research initiative?
"According to the latest information hosted on clinicaltrials.gov, this medical trial is actively enrolling participants. This study was publicly posted in late July 2020 and has recently been updated at the end of November 2022."
Answered by AI
Approximately how many participants are being enrolled in this clinical trial?
"Affirmative. The clinicaltrials.gov portal specifies that this experiment is actively recruiting participants, having been first published on July 24th 2020 and updated most recently November 3rd 2022. 70 volunteers are needed from across three research centres."
Answered by AI
Who else is applying?
What state do they live in?
Florida
What site did they apply to?
Miami VA Healthcare System
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
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