Study Stopped
low accrual
hCT-MSCs for COVID19 ARDS
Pilot Study of Safety and Efficacy of Cord Tissue Derived Mesenchymal Stromal Cells (hCT-MSC) in COVID-19 Related Acute Respiratory Distress Syndrome (ARDS)
1 other identifier
interventional
12
1 country
5
Brief Summary
This is a 50 patient, Phase 1/2a multi-center pilot study to test the safety and to describe the preliminary efficacy of intravenous administration of allogenic human cord tissue mesenchymal stromal cells (hCT-MSC) as an investigational agent, under U.S. INDs 19968 (Duke) and 19937 (U Miami) to patients with acute respiratory distress syndrome (ARDS) due to COVID-19 infection (COVID-ARDS). The first 10 consecutive patients will receive investigational MSCs manufactured by Duke. In the second phase of the study, 40 additional patients will be randomized to receive placebo or investigational MSCs manufactured by Duke or University of Miami. Patients will be eligible for infusion of 3 daily consecutive doses of hCT-MSC or placebo if they have a confirmed diagnosis of COVID-19 and meet clinical and radiographic criteria for ARDS. Results from the first 10 patients will be compared with concurrent outcomes utilizing standard of care treatments in participating hospitals and in published reports in the medical literature. Results from the additional 40 patients will be combined with the first 10 and analyzed. The trial is relying on focused eligibility of the participants (patients with ARDS), single cohort with short trial time (4 weeks), and simple assessment of clinical outcome (survival, improvement of ARDS). This is a sequential design in the sense that after the first 10 patients are evaluated a decision will be made by the PIs and the Data Safety Monitoring Board whether to proceed with the exploratory randomized portion of the study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jun 2020
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2020
CompletedFirst Posted
Study publicly available on registry
May 22, 2020
CompletedStudy Start
First participant enrolled
June 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 16, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 16, 2022
CompletedResults Posted
Study results publicly available
December 20, 2022
CompletedDecember 20, 2022
November 1, 2022
1.7 years
May 21, 2020
October 24, 2022
November 29, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Number of Infusion Reactions
Number of infusion reactions measured by any one of the following: fever, anaphylaxis, rash, hypertension, hypotension, tachycardia, nausea, vomiting, or any other new or worsening symptoms associated with the infusion.
24 hours
Number of Delayed Reactions
Number of later reactions attributed to the investigational product as measured by any one of the following: rash, infection, allergic reaction, or any other delayed symptoms associated with infusion of the investigational product.
28 days
Number of Participants With Formation of New Anti-HLA Antibodies
Number of participants who form new anti-HLA antibodies as measured by an antibody screen test at 28 days post first infusion of the investigational product.
28 days
Secondary Outcomes (6)
Time to Recovery
up to 90 days
Number of Participants With an Increase in PaO2/FiO2 Ratio
4 days after MSCs
Days to Hospital Discharge to Home
90 days
Number of Ventilator Free Days
90 days
Number of Oxygen-free Days
28 days
- +1 more secondary outcomes
Study Arms (3)
Open Label infusion of hCT-MSC
EXPERIMENTALThe first 10 consecutive patients will all receive investigational product.
Randomized infusion of hCT-MSC
EXPERIMENTALAn interim analysis, for safety will be conducted and reviewed by the Data Safety and Monitoring Board (DSMB) after the first 10 patients have completed treatment and reached the 28 day endpoint. If there are no safety concerns, the trial will proceed with enrollment on the phase 2 portion of the study where the subsequent 40 patients will be randomized in a 1:1 fashion between treatment with MSCs and placebo. The investigational product will be further randomized to the MSCs manufactured by Duke or University of Miami. These products are considered to be comparable.
Randomized infusion of Placebo
PLACEBO COMPARATORAn interim analysis, for safety will be conducted and reviewed by the Data Safety and Monitoring Board (DSMB) after the first 10 patients have completed treatment and reached the 28 day endpoint. If there are no safety concerns, the trial will proceed with enrollment on the phase 2 portion of the study where the subsequent 40 patients will be randomized in a 1:1 fashion between treatment with MSCs and placebo
Interventions
Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University or University of Miami.
Placebo will be comprised of 40-80 mL of Plasmalyte-A + 1% Human Serum Albumin (HAS) prepared in an identical container to the one used for cell administration. The placebo product will undergo the same process of sterility testing including release inspection, transport and product custodian.
Eligibility Criteria
You may qualify if:
- The patient or legally authorized representative (LAR) must have the ability to understand and the willingness to provide a signed and dated informed consent form.
- Age 18 years and over
- The patient agrees to use adequate contraception for the duration of the treatment protocol and for 6 months post treatment.
- Positive RT- PCR testing for COVID-19 nucleic acid using nasopharyngeal swabbing or any other site
- Patient meets ARDS criteria and is on non-invasive or mechanical ventilation or high flow nasal cannula
- bilateral opacities on chest imaging consistent with pulmonary edema
- A need for positive pressure ventilation or high flow nasal cannula
- PaO2/FiO2 ratio ≤ 300 mmHg by arterial blood gas or SpO2/FiO2 imputation.
- Infiltrates not fully explained by cardiac failure or fluid overload in the physician's best clinical judgement
- Subjects requiring dialysis as a result of a COVID-19 infection will not be excluded.
You may not qualify if:
- Evidence of multiorgan failure involving one or more organs, excluding the lungs as defined below:
- Presence of shock, defined as MAP \< 65 mmHg with signs of peripheral hypoperfusion, or continuous infusion of 2 or more vasopressor or inotrope agents to maintain MAP ≥ 65 mmHg.
- Serum bilirubin \> 10 mg/dl
- Platelet count \< 50,000/ml
- Subjects requiring dialysis as a result of anything other than a COVID-19 infection will be excluded
- Evidence of acquired or congenital immunodeficiency (due to immunosuppressive therapy excluding steroid use for treatment of COVID-19 acute respiratory failure, HIV, previous treatment for cancer, etc.)
- History of metastatic cancer diagnosis or treatment in the past 1 year
- History of previous treatments with MSCs or other cell therapies
- Patient is co-enrolled in any other IND-sponsored clinical trials for COVID-19 or ARDs. Drugs that are administered under emergency use authorizations (EUA) by the FDA are permitted.
- Evidence of pregnancy or lactation
- Moribund patient not expected to survive \>24 hours
- Unable/unwilling to deliver lung protective ventilation
- Patient is receiving Extracorporeal Membrane Oxygenation (ECMO)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Joanne Kurtzberg, MDlead
- The Marcus Foundationcollaborator
Study Sites (5)
Boca Raton Regional Hospital
Boca Raton, Florida, 33486, United States
Jackson Memorial Hospital
Miami, Florida, 33136, United States
University of Miami Hospital
Miami, Florida, 33136, United States
New York Medical College
Valhalla, New York, 10595, United States
Duke Hospital
Durham, North Carolina, 27705, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Emily Poehlein, MB
- Organization
- Duke University
Study Officials
- PRINCIPAL INVESTIGATOR
Joanne Kurtzberg, MD
Duke Health
- PRINCIPAL INVESTIGATOR
Lingye Chen, MD
Duke Health
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Jerome S. Harris Distinguished Professor of Pediatrics
Study Record Dates
First Submitted
May 21, 2020
First Posted
May 22, 2020
Study Start
June 18, 2020
Primary Completion
February 16, 2022
Study Completion
February 16, 2022
Last Updated
December 20, 2022
Results First Posted
December 20, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share