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Mesenchymal Stromal Cells
Mesenchymal Stromal Cells for COVID-19 (SAMPSON-1 Trial)
Phase 1
Waitlist Available
Led By Charlie Strange, MD
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis with Mild or Moderate Pneumonia not requiring mechanical ventilation: Patient must have at least one of the following features: Bilateral pneumonia present on chest radiograph or computed tomography, Partial pressure of oxygen/fraction of inspired oxygen (PaO2/FiO2) on arterial blood gas showing: >100mmHg and ≤ 300mmHg regardless of oxygen dose at time of testing, Pulse oxygen saturation (SpO2) at rest ≤ 93% or any degree of hypoxia requiring supplemental oxygen
Willingness to undergo mechanical ventilation for worsening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14, 21 and 28 days
Awards & highlights
SAMPSON-1 Trial Summary
This trial will test the safety of giving 2 doses of MSCs to people with viral pneumonia, to see if it improves their oxygen response over 90 days.
Who is the study for?
This trial is for hospitalized individuals with COVID-19 or viral pneumonia, within 7 days of symptom onset, who don't need mechanical ventilation. Participants must be willing to consent and comply with the study, not pregnant or breastfeeding, without severe liver disease or other serious health conditions that could interfere with the trial.Check my eligibility
What is being tested?
The trial tests the safety and oxygen response over 90 days of two doses of allogeneic mesenchymal stromal cells from umbilical cords given intravenously on day 1 and day 3 to those with COVID-19 or viral pneumonias.See study design
What are the potential side effects?
Potential side effects may include reactions at the infusion site, allergic responses due to cell therapy, immune system complications, and possible impacts on underlying conditions; however specific side effects will be monitored throughout the trial.
SAMPSON-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have pneumonia but don't need a machine to help me breathe.
Select...
I am willing to be put on a ventilator if my condition worsens.
Select...
I am hospitalized with COVID-19 symptoms and tested positive.
SAMPSON-1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14, 21 and 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14, 21 and 28 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical deterioration
Secondary outcome measures
28 day mortality
Hospital mortality and length of stay
ICU transfer
+3 moreOther outcome measures
Anti-SARS-CoV-2 titers
Change is PaO2/FiO2 ratio from baseline to day 5
Nasopharyngeal swab SARS-CoV-2 RT-PCR
SAMPSON-1 Trial Design
1Treatment groups
Experimental Treatment
Group I: Allogeneic Mesenchymal Stromal Cell infusionExperimental Treatment1 Intervention
Intravenous infusion of 1.25-1.5 x 10^6 cells/kg with a maximal dose of 100 x 10^6 cells on days 1 and 3 after study enrollment.
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Who is running the clinical trial?
Pandorum International, Inc.UNKNOWN
Medical University of South CarolinaLead Sponsor
932 Previous Clinical Trials
7,394,380 Total Patients Enrolled
Charlie Strange, MDPrincipal InvestigatorMedical University of South Carolina
7 Previous Clinical Trials
839 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have received experimental COVID-19 treatments, but not convalescent plasma, dexamethasone, corticosteroids, or remdesivir.I am willing to be put on a ventilator if my condition worsens.I have pneumonia caused by lung cancer or another known reason.I have pneumonia but don't need a machine to help me breathe.You have HIV, hepatitis virus, or syphilis infection.I do not have tuberculosis, influenza, adenovirus, or other respiratory virus infections.I am hospitalized with COVID-19 symptoms and tested positive.You have a history of substance abuse that may make it hard for you to follow the testing rules.You are allergic to diphenhydramine or hydrocortisone.I am not pregnant, breastfeeding, nor planning to become pregnant or breastfeed during the study.I do not have severe liver disease.You are very sick and not expected to live longer than 24 hours.I have been on a breathing machine before joining the study, but use of high flow nasal oxygen or non-invasive ventilation is okay.I am currently on dialysis.I have a severe lung condition and need long-term oxygen.My kidney function is severely reduced.I have had a blood clot or stroke in the past 3 years.I have pneumonia caused by bacteria or other pathogens.I have a serious health condition that could affect my COVID-19 outcome, excluding skin cancer.I have been taking immunosuppressive drugs, like prednisone over 5mg daily, for the last month.
Research Study Groups:
This trial has the following groups:- Group 1: Allogeneic Mesenchymal Stromal Cell infusion
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Does this trial accept participants aged 50 or above?
"This clinical trial has set its inclusion criteria to include participants aged 18-80. Separately, there are 162 trials for minors and 1006 studies catering to seniors."
Answered by AI
How many individuals have enrolled in this clinical experiment?
"Affirmative. According to clinicaltrials.gov, this medical experiment was recently posted on May 4th 2022 and is currently in the process of recruiting 10 study participants from 1 location."
Answered by AI
What are the eligibility criteria for participation in this experiment?
"The present medical trial is seeking 10 patients, aged 18-80 years old, who are hospitalized with signs and symptoms of COVID-19 pneumonia confirmed by a positive SARS-CoV2 RTPCR. In addition to giving written consent for the study protocol requirements, participants must demonstrate bilateral pneumonia on radiographic imaging and evidence of hypoxia requiring supplemental oxygen (PaO2/FiO2 < 300 mmHg), as well as agreeing to potential intubation should their condition worsen."
Answered by AI
Are there any open enrolment opportunities for the current clinical trial?
"Clinicaltrials.gov reveals that this clinical trial is actively attempting to identify suitable participants, having first been posted on the 4th of May 2022 and receiving its most recent update today."
Answered by AI
Has the Food and Drug Administration authorized Allogeneic Mesenchymal Stromal Cells for clinical use?
"The safety of Allogeneic Mesenchymal Stromal Cells has been scarcely documented in clinical research, thus it was given a rating of 1."
Answered by AI
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