Safety and Effectiveness of EV-Pure + WJ-Pure Treatment on Pulmonary Fibrosis Secondary to Covid-19

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Brief Title

Safety and Effectiveness of EV-Pure + WJ-Pure Treatment on Pulmonary Fibrosis Secondary to Covid-19

Official Title

Safety and Effectiveness of EV-Pure + WJ-Pure Treatment on Pulmonary Fibrosis Secondary to Covid-19

Brief Summary

      The COVID-induced fibrotic lung damage continues long after viral infection has subsided and
      is exhibited by severe respiratory pathology and concomitant symptoms. The long-lasting
      sequelae in patients who have recovered from severe COVID indicate that there is a 30% chance
      of developing a persistent respiratory system pathology and a 10% chance of developing a
      severe pathology. The symptoms of lung fibrosis include a severe disruption of respiration,
      reduction of exercise tolerance, and concomitant development of persistent fibrotic lung
      damage. This study intends to evaluate benefits of a combination of WJPure and EVPure in
      Covid-19 patients exhibiting pulmonary fibrosis.

Detailed Description

      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):

        1. Experimental/treatment arm: EV-Pure™ and WJ-Pure™ plus standard care

        2. Placebo: Saline plus standard care

      The study duration would be 5 days of treatment plus 12 weeks follow up.

Study Phase

Phase 1

Study Type


Primary Outcome

Evaluate incidences of Treatment-Emergent Adverse Events following following EV-Pure™ and WJ-Pure™ administeration to patients exhibiting Covid induced Pulmonary Fibrosis.

Secondary Outcome

 Change in Pulse Oximetry at Rest and During the 6MWT


Pulmonary Fibrosis


EV-Pure™ and WJ-Pure™ plus standard care

Study Arms / Comparison Groups

 Experimental/treatment arm


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

June 2022

Completion Date

December 2022

Primary Completion Date

October 2022

Eligibility Criteria

        Inclusion Criteria:

          -  Subjects will be eligible for enrollment in the study only if they meet the following

               1. Male or female, aged between 25 years (including) to 90 years old

               2. Confirmed and documented COVID-19 infection history with confirmed diagnosis of
                  Pulmonary Fibrosis

               3. Negative to current Covid-19 infection as tested by RT-PCR tests

               4. Able to perform a 6-minute walk test

               5. Blood routine, liver and kidney functions test values are within controllable

                    1. Adequate hepatic function as evidenced by ALT, AST and LDH < 2X ULN and
                       bilirubin < 1.5X ULN for the reference lab

                    2. Adequate renal function as evidenced by a serum creatinine ≤ 1.5 X ULN for
                       the reference laboratory OR a calculated creatinine clearance of ≥ 60 mL/min
                       by the Cockcroft-Gault Equation

                    3. Adequate hematopoietic function as evidenced by white blood cells ≥ 3x109 /
                       L and platelets ≥ 100x109 / L

               6. 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:

               1. Clinically relevant heart condition such as, but not limited to, uncontrolled
                  heart failure, severe pulmonary hypertension, atrial fibrillation or significant
                  congenital heart disease

               2. Severe asthma on chronic therapy with biologics or steroids

               3. Active smokers as defined as individuals who currently smokes at least one
                  cigarette or equivalent product a day. (Ex-smokers who had regularly smoked but
                  who had not smoked the previous month are eligible)

               4. Evidence of active malignancy, or prior history of active malignancy not in

               5. Life expectancy of < 6 months

               6. Patient included in another ongoing interventional therapeutic trial.

               7. Pregnant or Lactating.

               8. Serious or life-threatening co-morbidities, that in the opinion of the
                  investigators, may compromise the safety or compliance with the study guidelines
                  and tracking.




25 Years - 90 Years

Accepts Healthy Volunteers



, 2407504893, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations



Organization ID


Responsible Party


Study Sponsor

Vitti Labs, LLC

Study Sponsor

, , 

Verification Date

June 2022