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Stem Cell Therapy

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

Phase 2
Recruiting
Research Sponsored by Vitti Labs, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to perform a 6-minute walk test
Adequate hepatic function as evidenced by ALT and AST < 2X ULN and bilirubin < 1.5X ULN for the reference lab
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

Study Summary

This trial will evaluate if a combination of WJPure and EVPure can help people with lung fibrosis caused by Covid-19.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects aren't listed here, clinical trials like this one typically monitor for any adverse reactions ranging from mild (like headaches or nausea) to more serious ones related to organ functions which will be closely watched given the participants' existing lung condition.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can walk for 6 minutes without assistance.
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My liver tests are within normal limits.
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I had COVID-19 and now have been diagnosed with Pulmonary Fibrosis.
Select...
I am between 25 and 90 years old.
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My kidney function is within the normal range.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Evaluate incidences of Treatment-Emergent Adverse Events following following VL-PX10 and VL-P22 administration to patients exhibiting Covid induced Pulmonary Fibrosis.
To evaluate the efficacy of VL-PX10 and VL-P22 administration in alleviating long term symptoms of Covid induced Pulmonary Fibrosis, compared to placebo.
Secondary outcome measures
Change in Pulse Oximetry During the 6MWT
Incidence of Re-Hospitalization
Quality of Life assessment as collected using the SF-36

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental/treatment armExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Vitti Labs, LLCLead Sponsor
2 Previous Clinical Trials
29 Total Patients Enrolled

Media Library

EV-Pure™ and WJ-Pure™ (Stem Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05387239 — Phase 2
Pulmonary Fibrosis Research Study Groups: Experimental/treatment arm, Placebo
Pulmonary Fibrosis Clinical Trial 2023: EV-Pure™ and WJ-Pure™ Highlights & Side Effects. Trial Name: NCT05387239 — Phase 2
EV-Pure™ and WJ-Pure™ (Stem Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05387239 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment in this investigation still ongoing?

"Yes, per the details on clinicaltrials.gov it appears that this medical trial is still accepting applicants. This study has been online since November 30th 2022 and was most recently updated on October 11th 2022. It requires 20 participants to be recruited from one location."

Answered by AI

Is this research endeavor offering enrollment to persons below the age of eighty-five?

"Complying with the eligibility requirements of this clinical trial, adults aged 25 or older and no more than 90 years young are eligible for enrollment."

Answered by AI

What is the cap on enrolment for this research endeavor?

"Affirmative. According to the clinicaltrials.gov database, this study is currently recruiting subjects and was initially posted on November 30th 2022 before being updated lastly on October 11th 2022. It requires 20 participants enrolled at a single medical centre."

Answered by AI

Am I eligible to be a subject in this experimental research?

"This clinical trial is recruiting 20 individuals between the ages of 25 and 90 who have been clinically diagnosed with pulmonary fibrosis. Other requirements include being male or female, having a negative RT-PCR test for Covid-19, performing a 6 minute walk test, possessing blood routine values within controllable range, adequate hepatic function as evidenced by ALT AST and LDH < 2X ULN and bilirubin < 1.5X ULN for reference lab testing ,adequate renal function as evidenced by serum creatinine ≤ 1.5 X ULNfor the reference laboratory OR calculated creatinine clearance of ≥"

Answered by AI

Has the FDA officially sanctioned the combination of EV-Pure™ and WJ-Pure™ with a conventional approach?

"EV-Pure™ and WJ-Pure™ plus standard care score a 1 on our safety scale, due to the preliminary level of evidence currently available. This is in line with expectations for a Phase 1 trial."

Answered by AI

Who else is applying?

What state do they live in?
Florida
What site did they apply to?
Kit Bartalos
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Safety and Effectiveness of VL-PX10 + VL-P22 Treatment on Pulmonary Fibrosis Secondary to Covid-19
2022. "Safety and Effectiveness of VL-PX10 + VL-P22 Treatment on Pulmonary Fibrosis Secondary to Covid-19". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05387239.
All > Pulmonary Fibrosis
~4 spots leftby Nov 2024
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