Safety and Effectiveness of EV-Pure + WJ-Pure Treatment on Pulmonary Fibrosis Secondary to Covid-19
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05387239|
Recruitment Status : Recruiting
First Posted : May 24, 2022
Last Update Posted : June 8, 2022
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Fibrosis COVID-19 Respiratory Infection||Drug: EV-Pure™ and WJ-Pure™ plus standard care Drug: Placebo||Phase 1|
Multiple clinical trials are underway to explore options for treatment of pulmonary fibrosis in patients with history of COVID. Mesenchymal stem cell (MSC)-based therapies have been used worldwide for various pulmonary diseases. A recent review of over 110 reports of clinical trials worldwide with MSC-based therapies in pulmonary diseases found that these therapies have been reported to be safe and effective in the treatment of acute/viral pulmonary disease, community-acquired pneumonia (CAP), chronic obstructive pulmonary disease (COPD), bronchopulmonary dysplasia (BPD), interstitial lung diseases (ILD), chronic pulmonary fibrosis, bronchiolitis obliterans syndrome (BOS) and lung cancer. A phase 2 clinical trial in 101 severe Covid-19 patients with lung damage using human umbilical cord derived MSCs found that the treatment exerted numerical improvement in whole lung lesion volume and the 6-minute walk test from baseline to day 28 compared with the placebo.
This proof of concept, double-blind, placebo-controlled trial will evaluate the safety and efficacy of intravenous infusion of EV-Pure™ and WJ-Pure™, versus placebo, for use in the treatment of Covid induced Pulmonary Fibrosis. 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: Saline plus standard care
The study duration would be 5 days of treatment plus 12 weeks follow up.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Safety and Effectiveness of EV-Pure + WJ-Pure Treatment on Pulmonary Fibrosis Secondary to Covid-19|
|Estimated Study Start Date :||June 2022|
|Estimated Primary Completion Date :||October 2022|
|Estimated Study Completion Date :||December 2022|
|Experimental: Experimental/treatment arm||
Drug: EV-Pure™ and WJ-Pure™ plus standard care
The treatment consists of administration of WJ-Pure™ and EV-Pure™ plus standard care
|Placebo Comparator: Placebo||
Saline plus standard care
- Evaluate incidences of Treatment-Emergent Adverse Events following following EV-Pure™ and WJ-Pure™ administeration to patients exhibiting Covid induced Pulmonary Fibrosis. [ Time Frame: 3 months ]Presence of adverse events in less than 10% of the study population, as a measure of safety
- To evaluate the efficacy of EV-Pure™ and WJ-Pure™ administration in alleviating long term symptoms of Covid induced Pulmonary Fibrosis, compared to placebo [ Time Frame: 3 months ]Change in distance walked on the six-minute walk test (6MWT). The 6MWT is a validated endpoint commonly used in clinical trial research.
- Change in Pulse Oximetry at Rest and During the 6MWT [ Time Frame: 3 months ]Oxygen saturation (pulse oximetry) at rest and during the 6-minute walk test (6MWT)
- Incidence of Re-Hospitalization [ Time Frame: 3 months ]Incidence of hospitalization after initial discharge and initiating treatment
- Quality of Life assessment as collected using the SF-36 [ Time Frame: 3 months ]The SF-36 (v2) is a self-administered questionnaire containing 36 items that measures functional status, well-being, and overall evaluation of health in 8 domains.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05387239
|Contact: Mukesh Kumarfirstname.lastname@example.org|
|United States, Missouri|
|Liberty, Missouri, United States, 64068|
|Contact: Kit Bartalos, DO|