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

Learn more about:
Related Clinical Trial
Safety and Effectiveness of EV-Pure + WJ-Pure Treatment on Pulmonary Fibrosis Secondary to Covid-19 Pulmonary Fibrosis Foundation Community Registry FAPI PET for Lung Fibrosis Expanded Access for Patients With Pulmonary Hypertension Associated With Pulmonary Fibrosis A Study to Evaluate the Safety and Pharmacokinetic Properties of LASN01 in Healthy Subjects and in Patients With Pulmonary Fibrosis Comparison of Pulmonary Telerehabilitation and Physical Activity Recommendations in Patients With Post Covid Fibrosis Pulmonary Rehabilitation in Non-chronic Obstructive Pulmonary Disease Patients. Imaging of Pathologic Fibrosis Using 68Ga-FAP-2286 Head-to-head Comparison of Diagnosis Value of Pulmonary Fibrosis on 68Ga-FAPI-04 and 18F-FDG PET-CT Post COVID-19 Interstitial Lung Disease: A Study of Genetic and Environmental Interactions Pulmonary Fibrosis During Severe COVID-19 Pneumonia Safety and Effectiveness of Cyclosporin in the Management of COVID19 ARDS Patients in Alexandria University Hospital Post Acute Sequelae of COVID-19 Assessing the Efficacy of Sirolimus in Patients With COVID-19 Pneumonia for Prevention of Post-COVID Fibrosis Global Utilization And Registry Database for Improved preservAtion of doNor LUNGs Dyspnea and Idiopathic Pulmonary Fibrosis COVID-19 Pathophysiology of Long Term Implications The MONACO Cell Therapy Study: Monocytes as an Anti-fibrotic Treatment After COVID-19 A Non-pharmacological Cough Control Therapy Exhaled Breath Analysis Using eNose Technology as a Biomarker for Diagnosis and Disease Progression in Fibrotic ILD The TELO-SCOPE Study: Attenuating Telomere Attrition With Danazol. Is There Scope to Dramatically Improve Health Outcomes for Adults and Children With Pulmonary Fibrosis The Study Will Evaluate the Use of Nintedanib in Slowing Lung Fibrosis in Patients With Pulmonary Infiltrates Related to COVID Advancing Prevention of Pulmonary Fibrosis Vaccination of Ex-acute COVID Patied-19 Patients With Fibrosing Lung Syndrome at Discharge Intramuscular Effect of Polymerized Type I Collagen on the Cytokine Storm in COVID-19 Patients BIO 300 Oral Suspension in Discharged COVID-19 Patients Development of Interstitial Lung Disease (ILD) in Patients With Severe SARS-CoV-2 Infection (COVID-19) LUNG FIBROTIC CHANGES ASSOCIATED WITH SARS-CoV-2 INFECTION European Management Platform for Childhood Interstitial Lung Diseases – chILD-EU Register and Biobank Neoadjuvant Therapy for Esophageal Cancer and Cardiopulmonary Physiology Developing Optimal Parameters for Hyperpolarized Noble Gas and Inert Fluorinated Gas MRI of Lung Disorders Oxygen Savings With Administered Oxygen and High Flow Ambient Air At Rest Long-term Outcome and Lung Capacity in Survivors of ARDS Due to Influenza A (H1N1) v2009 The RESPIFLU Study Using Health-related Quality of Life (HRQL) in Routine Clinical Care Rheumatoid Arthritis-Associated Interstitial Lung Disease: Characterization of Lung Disease Progression Safety and Efficacy Study of Depelestat in Acute Respiratory Distress Syndrome (ARDS) Patients Written Disclosure Therapy for Anxiety and Stress in Patients With Chronic Lung Disease Accuracy of Spircare Device as Compared to the Conventional Plethysmograph Autologous CD117+ Progenitor Cell Mobilization for Lung Transplantation Segmental Bronchoalveolar Lavage Comparative Study of 3 Portable Oxygen Concentrators During a 6-minute Walk Test in Patients With Chronic Lung Disease Spanish Version of the KBILD Questionnaire Pirfenidone in the Chronic Hypersensitivity Pneumonitis Treatment Clinical Outcomes and Molecular Phenotypes in Smokers With Parenchymal Lung Disease An Open-Label Study of the Safety of Interferon Gamma-1b in Patients With IPF Integrated Radiographic and Metabolomics Risk Assessment in Patients With Interstitial Lung Diseases Computerized Lung Sound Analysis Evaluating the Effectiveness of Prednisone, Azathioprine, and N-acetylcysteine in Patients With IPF Assessment of Pulmonary Specialty Physicians’ Approach to Advanced Care Planning in Patients With Chronic Pulmonary Diseases Non-Interventional Study (NIS) Collecting Experiences For IPF in Taiwan Identification of Genes Associated With Lung Disease in Patients With Rheumatoid Arthritis Linkage Study in Familial Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis: a Case-control Study A Randomized, Double-Blind, Three-Arm, Phase 3b Study Comparing the Safety and Efficacy of Interferon Gamma-1b With Azathioprine, and Azathioprine Alone in Patients With IPF Receiving Prednisone Trial of Concurrent Versus Sequential Tamoxifen With Radiotherapy in Breast Cancer Patients Specimen Collection for Individuals With Lung Disease Associated With Rheumatoid Arthritis The INSPIRE Trial: A Study of Interferon Gamma-1b for Idiopathic Pulmonary Fibrosis (IPF) Diagnostic Value of KL-6 in ILD Interferon-alpha Treatment of Chronic Cough in Chronic Obstructive Pulmonary Disease and Idiopathic Pulmonary Fibrosis A Study to Characterize the Safety, PK and Biological Activity of CC-930 in Idiopathic Pulmonary Fibrosis (IPF) Pomalidomide for Cough in Patients With Idiopathic Pulmonary Fibrosis Safety and PK Study of BIBF 1120 in Japanese Patients With IPF: Follow up Study From 1199.31(NCT01136174) Explorative Study on the Molecular Pathology of Lung Fibrosis by Combination of Clinical Assessment and System Biology An Open-Label Study of the Safety and Efficacy of Subcutaneous Recombinant Interferon-Gamma 1b (IFN-Gamma 1b) in Patients With Idiopathic Pulmonary Fibrosis (IPF) Oral Treprostinil in Subjects With Pulmonary Hypertension Associated With Pulmonary Fibrosis A Dose Escalation Study to Assess the Safety and Efficacy of Pulsed iNO in Subjects With Pulmonary Fibrosis Safety and PK Study of CC-90001 in Subjects With Pulmonary Fibrosis Inhaled Iloprost in Adults With Abnormal Pulmonary Pressure and Associated With Idiopathic Pulmonary Fibrosis Clinical Trial of Low Dose Oral Interferon Alpha in Idiopathic Pulmonary Fibrosis Supporting Adherence to Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis Gleevec Idiopathic Pulmonary Fibrosis (IPF) Study RENOVATE Fibrosis: Pilot Study Comparing HFNC Versus NIPPV in Acute Respiratory Failure in Patients With Pulmonary Fibrosis Safety And Efficacy of BIBF 1120 in Idiopathic Pulmonary Fibrosis Safety and Efficacy of BIBF 1120 at High Dose in Idiopathic Pulmonary Fibrosis Patients Effect of Ambulatory Oxygen on the Walking Test in Patients With Pulmonary Fibrosis Safety and Efficacy of BIBF 1120 at High Dose in Idiopathic Pulmonary Fibrosis Patients II Genetic Polymorphisms in Idiopathic Pulmonary Fibrosis (IPF) Sildenafil to Increase Exercise Capacity in Individuals With Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension A Pilot Study of Aerosol Interferon-gamma for Treatment of Idiopathic Pulmonary Fibrosis Microarray Analysis of Gene Expression in Idiopathic Pulmonary Fibrosis (IPF) Sildenafil Trial of Exercise Performance in Idiopathic Pulmonary Fibrosis Pilot Study of Pirfenidone in Pulmonary Fibrosis With Anti-myeloperoxydase Antibodies Lung Disease Associated With Rheumatoid Arthritis Roll Over Study From 1199.30 BIBF 1120 in Idiopathic Pulmonary Fibrosis (IPF) Study of the Effects of High-dose N-acetylcysteine (NAC) in Idiopathic Pulmonary Fibrosis (IPF) Efficiency Study for Acute Radiation-induced and Chemotherapy-induced Pulmonary Fibrosis With Bevasizumab Study Evaluating the Safety and Efficacy of Etanercept in Patients With Idiopathic Pulmonary Fibrosis Study on Phenotypic Characterization of Combined Pulmonary Fibrosis and Emphysema Genetics of the Combined Pulmonary Fibrosis and Emphysema Syndrome A Study to Evaluate the Safety and Effectiveness of CNTO 888 Administered Intravenously (IV) in Participants With Idiopathic Pulmonary Fibrosis (IPF) Safety Study of Oral Pirfenidone in Patients With Pulmonary Fibrosis/Idiopathic Pulmonary Fibrosis A Study Measuring the Effectiveness, Safety, and Tolerability of BMS-986278 in Participants With Lung Fibrosis Assessment of Peripheral Endothelial Function in Idiopathic Pulmonary Fibrosis Preliminary Evaluation of [68Ga]CBP8 in Healthy Individuals, Lung Cancer, and Idiopathic Pulmonary Fibrosis Patients Effects of Pulmonary Rehabilitation on Functional and Health Status Measures in Pulmonary Fibrosis Targeting Vascular Reactivity in Idiopathic Pulmonary Fibrosis Supplemental Oxygen in Pulmonary Fibrosis Explanted Lung Tissues With Pulmonary Fibrosis Pulmonary Fibrosis and Telomerase Mutation Study Dyspnea in Patients With Pulmonary Fibrosis

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