Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles Infusion Treatment for Post-Acute and Chronic Post-COVID-19 Syndrome: A Phase I/II Clinical Trial

Direct Biologics, LLC0 sites60 target enrollmentNovember 2024

ConditionsCovid19 Postviral Syndrome Dyspnea

InterventionsSaline Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles

DrugsBone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles

Overview

Phase: Phase 1
Intervention: Saline
Conditions: Covid19
Sponsor: Direct Biologics, LLC
Enrollment: 60
Primary Endpoint: Increased distance on Six Minute Walk Test (6MWT)
Status: Withdrawn
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This is a Phase I/II trial to evaluate the safety and efficacy of intravenous (IV) administration of bone marrow mesenchymal stem cell derived extracellular vesicles (EV), ExoFlo, as treatment for Post-Acute COVID-19 and Chronic Post-COVID-19 syndrome.

Detailed Description

To evaluate the safety and efficacy of intravenous (IV) administration of bone marrow mesenchymal stem cell derived extracellular vesicles (EV), ExoFlo, as treatment for Post-Acute COVID-19 and Chronic Post-COVID-19 syndrome.

Registry

clinicaltrials.gov

Start Date

November 2024

End Date

December 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Direct Biologics, LLC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Provision of signed and dated informed consent form (either by the individual or by the individual's healthcare proxy).
•Stated willingness to comply with all study procedures and availability for the duration of the study
•Male or female aged 18-
•Discharged from recent hospitalization for severe COVID-19 disease requiring supplemental oxygen but not requiring mechanical ventilation or ECMO or dialysis.
•Must be between 4 to 20 weeks since onset of acute COVID-19 symptoms onset.
•No return to baseline health or hiatus between acute COVID-19 and onset of post-acute COVID-19 or chronic post-COVID-19 syndrome.
•Current SARS-CoV-2 RT PCR must be negative prior to enrollment.
•At least 2 or more persistent symptoms frequently reported for post-acute COVID-19 or chronic post-COVID-19 syndrome such as fatigue, cough, headache, body aches, fever, chills, loss of taste, loss of smell, diarrhea, congestion, dyspnea, sore throat, chest pain, abdominal pain, confusion, or vomiting must be moderate in severity based on modified CDC Symptoms Questionnaire (See Section 11.1 for severity scoring system).
•Medical Resource Council Dyspnea Score of \< 3 out of
•Baseline EQ-5D-5L must be higher than

Exclusion Criteria

•Vulnerable populations such as pregnant patients, children, individuals with severe physical or mental disabilities who cannot provide meaningful consent.
•Active malignancy requiring treatment within the last five years.
•Major physical trauma in the last 3 months, including motor vehicle accidents, assaults, mechanical falls with sequelae of significant bleeding or craniofacial bruising, and surgeries.
•Patients with persistent symptoms due to any of the following chronic comorbidities such as active tuberculosis or cystic fibrosis, chronic respiratory disease including chronic obstructive pulmonary disease or pulmonary fibrosis requiring baseline home oxygen \> 5 L O2/min, history of unstable angina or a heart attack during the last 12 months, pulmonary hypertension, hepatic impairment, chronic kidney disease, uncontrolled diabetes, substance abuse, severe osteoarthritis, HIV, migraine disorder, fibromyalgia, dementia, connective tissue disorders, and endocrine disorders.
•Depression as screened by positive Patient Health Questionnaire (PHQ2) and confirmed as moderate or higher severity on PHQ9 (See Appendix 11.5). Of note, subjects found to have moderate or higher on PHQ-9 will be referred for appropriate outpatient psychiatric evaluation and intervention for their depression.
•Vital sign abnormalities: temperature ≥ 38 °C, temperature \< 35 °C; systolic blood pressure (SBP) \< 90 mmHg, SBP ≥ 170 mmHg; diastolic blood pressure (DBP) \< 50 mmHg, DBP ≥ 100 mmHg; heart rate (HR) \< 50 beats per minute (BPM), HR ≥ 120 BPM.
•Lab abnormalities: WBC ≥ 12,000 /μL, Creatinine ≥ 1.5 mg/dL, AST ≥ 100 IU/l, and/or ALT ≥ 100 IU/I
•Patients who require rolling walker or wheelchair or higher level of assistance for ambulation.