Back to resultsSafety and Effectiveness of Placental Derived Exosomes and Umbilical Cord Mesenchymal Stem Cells in Moderate to Severe Acute Respiratory Distress Syndrome (ARDS) Associated With the Novel Corona Virus Infection (COVID-19)
Primary Purpose
COVID-19 Acute Respiratory Distress Syndrome, Respiratory Distress Syndrome
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
EV-Pure™ and WJ-Pure™
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 Acute Respiratory Distress Syndrome
Eligibility Criteria
Inclusion Criteria:
Subjects will be eligible for enrollment in the study only if they meet the following criteria:
- Male or female, aged at 18 years (including) to 75 years old.
- Patient with a confirmed SARS-CoV-2 infection (by positive reverse-transcription polymerase chain reaction (RT-PCR) from nasopharyngeal sample or any other sample)
- Hospitalized with moderate to severe ARDS.
Have ARDS or acute lung injury, comply with any of the following:
i. Respiratory distress, Respiratory rate (RR) ≥ 30 times/min ii. Pulse oxygen saturation (SpO2) at rest ≤ 93% iii. Partial pressure of oxygen/fraction of inspired oxygen (PaO2/FiO2) ≤ 300mmHg
- If childbearing age: agree to practice effective birth control from screening until 12 weeks after the last study treatment.
Exclusion Criteria:
Subjects will be ineligible for enrollment in the study if they meet any of the following criteria:
- Patient under invasive mechanical ventilation for more than 48 hours
- Allergic or hypersensitive to any of the ingredients.
- Pneumonia caused by bacteria, mycoplasma, chlamydia, legionella, fungi or other viruses.
- Obstructive HABP/VABP induced by lung cancer or other known causes.
- Carcinoid syndrome.
- History of long-term use of immunosuppressive agents.
- History of Class III or IV pulmonary arterial hypertension.
- Patient with chronic respiratory disease under oxygen therapy.
- Undergoing hemodialysis or peritoneal dialysis.
- Estimated or actual rate of creatinine clearance < 15 mL/min.
- History of moderate and severe liver disease (Child-Pugh score >12).
- History of deep venous thrombosis or pulmonary embolism within the last 3 years.
- Undergoing extracorporeal membrane oxygenation (ECMO) or high-frequency oscillatory ventilation support.
- Patient included in another ongoing interventional therapeutic trial.
- Pregnant or Lactating.
- Any condition of unsuitable for the study determined by Principal Investigator (PI).
Sites / Locations
- Kit BartalosRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental/treatment arm
Placebo
Arm Description
Outcomes
Primary Outcome Measures
To Assess the safety of EV-Pure™ and WJ-Pure™ administration in patients exhibiting moderate to severe ARDS associated with COVID-19, compared to placebo.
Evaluate incidences of Treatment-Emergent Adverse Events following EV-Pure™ and WJ-Pure™ administeration in patients exhibiting moderate to severe ARDS associated with COVID-19 compared to placebo. Presence of adverse events in less than 10% of the study population, as a measure of safety
To assess the efficacy of EV-Pure™ and WJ-Pure™ compared to placebo, in patients with moderate to severe ARDS assoociated with COVID-19
Clinical data will be evaluated to determine if there were any significant changes in the COVID-19 symptoms in patients in the treated versus placebo groups. The following information will be collected to evaluate the effectiveness of the treatment at 4 weeks post- treatment:
Discharged home on no supplemental oxygen
Discharged home on supplemental oxygen
Continued hospitalization on no oxygen
Continued hospitalization on oxygen but not in ICU
Continued hospitalization on oxygen in ICU (invasive and noninvasive ventilatory support)
Death
Secondary Outcome Measures
Time to clinical improvement
The following information will be collected from the subjects during the follow-up visits or calls:
Medical history review
Physical exam and vital signs
Assessment for delayed adverse reactions
Overall Survival
Survival of the subjects in the 2 arms of the study
COVID-19 polymerase chain reaction (PCR) test result as negative
COVID-19 polymerase chain reaction (PCR) test result as negative in the subjects in the 2 arms of the study
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05387278
Brief Title
Safety and Effectiveness of Placental Derived Exosomes and Umbilical Cord Mesenchymal Stem Cells in Moderate to Severe Acute Respiratory Distress Syndrome (ARDS) Associated With the Novel Corona Virus Infection (COVID-19)
Official Title
Safety and Effectiveness of Placental Derived Exosomes and Umbilical Cord Mesenchymal Stem Cells in Moderate to Severe Acute Respiratory Distress Syndrome (ARDS) Associated With the Novel Corona Virus Infection (COVID-19)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 20, 2023 (Anticipated)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vitti Labs, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Recent advances have been made in prevention of the viral infection via vaccines but there is still need for effective treatment options for patients. Novel therapies need to be developed to further improve clinical outcomes. The biggest medical challenge in the response to COVID-19 is ARDS requiring hospitalization in an intensive care setting and ventilator dependence. Intravenously administered umbilical cord derived exosomes and stem cells have been reported in literature to alleviate pulmonary distress in such patients.
The purpose of this study is to explore the safety and benefits of intravenous administration of WJPure and EVPure in the treatment of COVID-19 patients with moderate to severe ARDS. .
Detailed Description
One of the hallmark features of the progression of COVID-19 is lung injury from the viral infection leading to potentially acute respiratory distress syndrome (ARDS) and respiratory failure requiring ventilator support. In patients who survive ARDS, regardless of the pathology, there is evidence that their long-term quality of life is adversely affected.
The rationale for the dose and dosing regimen proposed in this study is based on the safe administration and benefits of this treatment regimen reported to us last year by physicians trying to treat moderate to severe COVID-19 patients. In those reports, the intravenous route of administration was used. It has been reported that dosing every 2 days amplified the benefit of the combination of exosomes and mesenchymal stem cells. It has been suggested based on clinical experience that the exosomes and MSCs are complementary to one another as well as enhancing the innate abilities of both.
During the early days of the pandemic, intravenous infusion of a mixture of EV-Pure™ and WJ-Pure™ was reported to benefit hospitalized patients with moderate to severe COVID-19 related ARDS. This study is designed to systematically explore the risk and benefits of intravenous infusion of EV-Pure™ and WJ-Pure™ in the treatment of hospitalized COVID-19 patients with moderate to severe ARDS.
This is a proof of concept, double-blind, placebo-controlled trial to evaluate the safety and efficacy of intravenous infusion of EV-Pure™ and WJ-Pure™, versus placebo, for use in the treatment of moderate to severe ARDS related to COVID-19. This is an add-on treatment study; subjects will be allowed to take standard of care treatments available.
The study will have two arms (n=10 each):
Experimental/treatment arm: EV-Pure™ and WJ-Pure™ plus standard care
Placebo: Cryopreservation media plus standard care
The study duration would be 5 days of treatment plus 12 weeks follow up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Acute Respiratory Distress Syndrome, Respiratory Distress Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental/treatment arm
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
EV-Pure™ and WJ-Pure™
Intervention Description
The treatment consists of administration of WJ-Pure™ and EV-Pure™ plus standard care
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Cryopreservation media plus standard care
Primary Outcome Measure Information:
Title
To Assess the safety of EV-Pure™ and WJ-Pure™ administration in patients exhibiting moderate to severe ARDS associated with COVID-19, compared to placebo.
Description
Evaluate incidences of Treatment-Emergent Adverse Events following EV-Pure™ and WJ-Pure™ administeration in patients exhibiting moderate to severe ARDS associated with COVID-19 compared to placebo. Presence of adverse events in less than 10% of the study population, as a measure of safety
Time Frame
3 months
Title
To assess the efficacy of EV-Pure™ and WJ-Pure™ compared to placebo, in patients with moderate to severe ARDS assoociated with COVID-19
Description
Clinical data will be evaluated to determine if there were any significant changes in the COVID-19 symptoms in patients in the treated versus placebo groups. The following information will be collected to evaluate the effectiveness of the treatment at 4 weeks post- treatment:
Discharged home on no supplemental oxygen
Discharged home on supplemental oxygen
Continued hospitalization on no oxygen
Continued hospitalization on oxygen but not in ICU
Continued hospitalization on oxygen in ICU (invasive and noninvasive ventilatory support)
Death
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
Time to clinical improvement
Description
The following information will be collected from the subjects during the follow-up visits or calls:
Medical history review
Physical exam and vital signs
Assessment for delayed adverse reactions
Time Frame
3 months
Title
Overall Survival
Description
Survival of the subjects in the 2 arms of the study
Time Frame
3 months
Title
COVID-19 polymerase chain reaction (PCR) test result as negative
Description
COVID-19 polymerase chain reaction (PCR) test result as negative in the subjects in the 2 arms of the study
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects will be eligible for enrollment in the study only if they meet the following criteria:
Male or female, aged at 18 years (including) to 75 years old.
Patient with a confirmed SARS-CoV-2 infection (by positive reverse-transcription polymerase chain reaction (RT-PCR) from nasopharyngeal sample or any other sample)
Hospitalized with moderate to severe ARDS.
Have ARDS or acute lung injury, comply with any of the following:
i. Respiratory distress, Respiratory rate (RR) ≥ 30 times/min ii. Pulse oxygen saturation (SpO2) at rest ≤ 93% iii. Partial pressure of oxygen/fraction of inspired oxygen (PaO2/FiO2) ≤ 300mmHg
If childbearing age: agree to practice effective birth control from screening until 12 weeks after the last study treatment.
Exclusion Criteria:
Subjects will be ineligible for enrollment in the study if they meet any of the following criteria:
Patient under invasive mechanical ventilation for more than 48 hours
Allergic or hypersensitive to any of the ingredients.
Pneumonia caused by bacteria, mycoplasma, chlamydia, legionella, fungi or other viruses.
Obstructive HABP/VABP induced by lung cancer or other known causes.
Carcinoid syndrome.
History of long-term use of immunosuppressive agents.
History of Class III or IV pulmonary arterial hypertension.
Patient with chronic respiratory disease under oxygen therapy.
Undergoing hemodialysis or peritoneal dialysis.
Estimated or actual rate of creatinine clearance < 15 mL/min.
History of moderate and severe liver disease (Child-Pugh score >12).
History of deep venous thrombosis or pulmonary embolism within the last 3 years.
Undergoing extracorporeal membrane oxygenation (ECMO) or high-frequency oscillatory ventilation support.
Patient included in another ongoing interventional therapeutic trial.
Pregnant or Lactating.
Any condition of unsuitable for the study determined by Principal Investigator (PI).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mukesh Kumar
Phone
2407504893
Email
mkumar@fdamap.com
Facility Information:
Facility Name
Kit Bartalos
City
Liberty
State/Province
Missouri
ZIP/Postal Code
64068
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kit Bartalos, DO
12. IPD Sharing Statement
Learn more about this trial
Safety and Effectiveness of Placental Derived Exosomes and Umbilical Cord Mesenchymal Stem Cells in Moderate to Severe Acute Respiratory Distress Syndrome (ARDS) Associated With the Novel Corona Virus Infection (COVID-19)
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