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
Interventional
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
Condition
Pulmonary Fibrosis
Intervention
EV-Pure™ and WJ-Pure™ plus standard care
Study Arms / Comparison Groups
Experimental/treatment arm
Description:
Publications
* 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
Drug
Estimated Enrollment
20
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
criteria:
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
range
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
remission.
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.
Gender
All
Ages
25 Years - 90 Years
Accepts Healthy Volunteers
No
Contacts
, 2407504893, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT05387239
Organization ID
EW-02
Responsible Party
Sponsor
Study Sponsor
Vitti Labs, LLC
Study Sponsor
, ,
Verification Date
June 2022