EV-Pure™ + WJ-Pure™ for Pulmonary Fibrosis

Overseen By Mukesh Kumar

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Vitti Labs, LLC

Must not be taking: Biologics, Steroids

Disqualifiers: Heart condition, Severe asthma, Active smokers, Active malignancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 5 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination of treatments, EV-Pure™ and WJ-Pure™ (experimental therapies), to aid individuals with lung damage from COVID-19. The goal is to determine if these treatments can improve breathing, enhance exercise ability, and reduce lung scarring in those who developed pulmonary fibrosis after recovering from COVID-19. Suitable candidates include those who had COVID-19, now have lung fibrosis, and can walk for six minutes. Participants will receive either the treatment or a placebo (a non-active substance) to compare results. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that EV-Pure™ and WJ-Pure™ are likely to be safe for humans?

Research shows that EV-Pure™ and WJ-Pure™ treatments are being tested for safety and effectiveness in healing lung damage after COVID-19. Past patients have generally tolerated these treatments well. Studies suggest that EV-Pure™ and WJ-Pure™ may support lung health by boosting the immune system and aiding tissue repair, which is promising for lung issues.

No serious side effects have been reported so far, which is encouraging. However, since these treatments remain under study, more research is needed to fully understand their safety. Always consult a healthcare professional if you have any concerns before joining a clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for pulmonary fibrosis?

Researchers are excited about EV-Pure™ and WJ-Pure™ for pulmonary fibrosis because these treatments leverage cutting-edge approaches that stand out from traditional therapies. Unlike typical treatments such as antifibrotic drugs, which aim to slow down lung scarring, EV-Pure™ and WJ-Pure™ utilize extracellular vesicles and Wharton's jelly-derived mesenchymal stem cells, respectively. These components are believed to potentially repair lung tissue and reduce inflammation directly. This novel mechanism offers hope for not just slowing disease progression but possibly reversing some damage, which sets these treatments apart from current options.

What evidence suggests that EV-Pure™ and WJ-Pure™ might be an effective treatment for pulmonary fibrosis?

Research has shown that EV-Pure™ and WJ-Pure™, under study in this trial, might help treat lung damage caused by COVID-19. These treatments aim to heal lung tissue and ease breathing by reducing lung scarring. Studies have found that they can support lung health by controlling immune responses, potentially repairing damaged lung tissues. Early results suggest this approach could improve symptoms of lung fibrosis, such as difficulty breathing and reduced exercise capacity. Although more research is needed, these findings offer hope for those facing long-term lung issues after COVID-19. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for adults aged 25-90 with a history of COVID-19 and confirmed pulmonary fibrosis. They must have good kidney, liver, and blood cell function, not be currently infected with COVID-19, able to walk for six minutes unaided, and if of childbearing age, agree to use birth control. Excluded are those with severe heart conditions or other serious illnesses that could affect safety or compliance.

Inclusion Criteria

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

If childbearing age: agree to practice effective birth control from screening until 12 weeks after the last study treatment.

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

Exclusion Criteria

Pregnant or Lactating

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.

Life expectancy of < 6 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive intravenous infusion of VL-PX10 and VL-P22 or placebo for 5 days

5 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• EV-Pure™ and WJ-Pure™

Trial Overview The study tests the effectiveness of VL-PX10 combined with VL-P22 against lung damage from COVID-19 compared to a placebo group. Both groups receive standard care as well. The goal is to see if these treatments can improve breathing issues and exercise tolerance in patients who've developed pulmonary fibrosis after recovering from COVID-19.

How Is the Trial Designed?

Group I: Experimental/treatment arm Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Vitti Labs, LLC

Lead Sponsor

Trials

3

Recruited

50+

Citations

1. withpower.com withpower.com/trial/phase-1-covid-19-4-2022-fe82a

EV-Pure™ + WJ-Pure™ for Pulmonary Fibrosis These patients have lung damage and severe breathing issues. The treatment aims to repair lung tissue and improve breathing by reducing lung scarring. Show more.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10204512/

Nanotherapeutic Approaches to Treat COVID-19-Induced ... Safety and Effectiveness of EV-Pure + WJ-Pure Treatment on Pulmonary Fibrosis Secondary to Covid-19, Drug: EV-Pure™ and WJ-Pure™ plus standard care. Drug ...

3. mdpi.com mdpi.com/2075-4426/12/9/1393

Challenges in the Management of Post-COVID-19 ... Safety and Effectiveness of EV-Pure + WJ-Pure Treatment on Pulmonary Fibrosis Secondary to Covid-19. 2022. Available online: https://clinicaltrials.gov/ct2 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9537661/

Post–Coronavirus Disease 2019 Pulmonary Fibrosis Safety and effectiveness of EV-Pure + WJ-Pure treatment on pulmonary fibrosis secondary to COVID-19 [Internet] [cited 2022 Apr 20]. Available from: https ...

5. journals.physiology.org journals.physiology.org/doi/10.1152/physrev.00032.2024

Extracellular vesicles and the lung: from disease ... EVs can maintain lung health by regulating immune responses, inducing tissue repair, and maintaining lung homeostasis.

6. e-trd.org e-trd.org/journal/view.php?doi=10.4046/trd.2022.0053

Post–Coronavirus Disease 2019 Pulmonary Fibrosis Safety and effectiveness of EV-Pure + WJ-Pure treatment on pulmonary fibrosis secondary to COVID-19 [Internet]. Bethesda: U.S. National ...