Placental Derived Exosomes and Umbilical Cord Mesenchymal Stem Cells for COVID-19

Overseen By Mukesh Kumar

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Vitti Labs, LLC

Must not be taking: Immunosuppressants

Disqualifiers: Chronic respiratory disease, Liver disease, others

Compensation: Varies

Number of Visits: Unknown

Duration: 5 days

20 Participants Needed

Trial Summary

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 study team or your doctor.

What data supports the effectiveness of the treatment EV-Pure™ and WJ-Pure™ for COVID-19?

Research shows that treatments using mesenchymal stem cells (special cells that can develop into different types of cells) and their exosomes (tiny particles that help cells communicate) have been safe and potentially effective in improving lung function and reducing inflammation in severe COVID-19 cases. These treatments have shown promise in improving oxygen levels and reducing lung damage in patients. ^{1 2 3 4 5}

Is the treatment with placental derived exosomes and umbilical cord mesenchymal stem cells safe for humans?

Research on similar treatments, like exosomes and mesenchymal stem cells from bone marrow and umbilical cords, shows they are generally safe in humans. Studies found no serious side effects, though some patients experienced mild reactions like facial flushing and fever, which were temporary. ^{1 2 3 6 7}

How is the treatment with EV-Pure™ and WJ-Pure™ for COVID-19 different from other treatments?

This treatment is unique because it uses placental-derived exosomes and umbilical cord mesenchymal stem cells, which are believed to help modulate the immune system and reduce inflammation, potentially addressing the severe immune response seen in COVID-19. Unlike traditional drugs, this approach uses components derived from human tissues to potentially improve recovery and reduce severe symptoms. ^{1 2 3 8 9}

What is the purpose of this trial?

This trial tests a new treatment using special cells and particles from umbilical cords, given through a drip. It targets hospitalized COVID-19 patients with severe lung problems. The treatment aims to reduce lung damage and improve breathing by enhancing the body's natural healing abilities.

Eligibility Criteria

Inclusion Criteria

You are currently in the hospital with a serious lung condition called moderate to severe ARDS.

Patient with a confirmed SARS-CoV-2 infection (by positive reverse-transcription polymerase chain reaction (RT-PCR) from nasopharyngeal sample or any other sample)

ii. Pulse oxygen saturation (SpO2) at rest ≤ 93%

Exclusion Criteria

Carcinoid syndrome

Patient included in another ongoing interventional therapeutic trial

Pregnant or Lactating

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive intravenous infusion of EV-Pure™ and WJ-Pure™ or placebo for 5 days

5 days

Daily visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Regular follow-up visits or calls

Treatment Details

Interventions

• EV-Pure™ and WJ-Pure™
• Placebo

Participant Groups

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+

Findings from Research

In a study of 24 patients with severe COVID-19, treatment with ExoFlo™, derived from bone marrow stem cells, showed a high safety profile with no adverse events reported within 72 hours and an 83% survival rate.

Patients treated with ExoFlo experienced significant improvements in clinical status, including a 192% increase in oxygenation levels and notable reductions in inflammatory markers, suggesting its potential as a therapeutic option for severe COVID-19.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exosomes Derived from Bone Marrow Mesenchymal Stem Cells as Treatment for Severe COVID-19. Sengupta, V., Sengupta, S., Lazo, A., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Nebulized exosomes derived from allogenic adipose tissue mesenchymal stromal cells in patients with severe COVID-19: a pilot study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Exosomes Derived from Bone Marrow Mesenchymal Stem Cells as Treatment for Severe COVID-19. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Human umbilical cord-derived mesenchymal stem cell therapy in patients with COVID-19: a phase 1 clinical trial. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Mesenchymal stem cell therapy on top of triple therapy with remdesivir, dexamethasone, and tocilizumab improves PaO2/FiO2 in severe COVID-19 pneumonia. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Effect of human umbilical cord-derived mesenchymal stem cells on lung damage in severe COVID-19 patients: a randomized, double-blind, placebo-controlled phase 2 trial. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

MSC Therapies for COVID-19: Importance of Patient Coagulopathy, Thromboprophylaxis, Cell Product Quality and Mode of Delivery for Treatment Safety and Efficacy. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Mesenchymal Stem Cells for the Compassionate Treatment of Severe Acute Respiratory Distress Syndrome Due to COVID 19. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Cell therapy in patients with COVID-19 using Wharton's jelly mesenchymal stem cells: a phase 1 clinical trial. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Intravenous infusion of human umbilical cord Wharton's jelly-derived mesenchymal stem cells as a potential treatment for patients with COVID-19 pneumonia. [2022]