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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and potential benefits of two treatments, EV-Pure™ and WJ-Pure™ (placental-derived exosomes and umbilical cord mesenchymal stem cells), for COVID-19 patients with moderate to severe ARDS, a severe lung condition causing breathing difficulties. The researchers aim to determine if these treatments can reduce lung distress in hospitalized patients struggling to breathe. Participants must have a confirmed COVID-19 infection and experience moderate to severe breathing issues due to ARDS. The trial includes a treatment group and a placebo group for comparison. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Earlier studies have shown that treatments like EV-Pure™ and WJ-Pure™ are safe for people with COVID-19-related conditions. Research suggests these treatments do not cause major side effects, such as allergic reactions or other immediate problems. They are being tested to help people with breathing issues due to COVID-19. Although the safety results are encouraging, this trial is in an early stage, and the main goal is to ensure the treatment's safety for people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for COVID-19?

Researchers are excited about EV-Pure™ and WJ-Pure™ because they offer a novel approach to treating COVID-19. Unlike traditional treatments such as antivirals and monoclonal antibodies, these therapies utilize placental-derived exosomes and umbilical cord mesenchymal stem cells. These components have the potential to modulate the immune response and repair damaged tissues, which could lead to faster recovery times and fewer complications. This innovative mechanism of action sets them apart from existing treatments, making them a promising option in the fight against COVID-19.

What evidence suggests that EV-Pure™ and WJ-Pure™ might be effective treatments for COVID-19 with ARDS?

This trial will compare the effects of a treatment using special cells from umbilical cords, known as EV-Pure™ and WJ-Pure™, with a placebo. Research has shown that treatments using these cells may help people with severe COVID-19 by reducing lung damage and aiding recovery in patients with serious breathing problems. These cells can repair damaged tissue and lower harmful swelling in the body. Early studies suggest that these treatments can improve health outcomes for patients with severe COVID-19 pneumonia. Although more research is needed, these early results indicate possible benefits for patients with moderate to severe COVID-19-related breathing issues. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• EV-Pure™ and WJ-Pure™
• Placebo

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+

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05387278

Study Details | NCT05387278 | Safety and Effectiveness of ... Intravenously administered umbilical cord derived exosomes and stem cells have been reported in literature to alleviate pulmonary distress in such patients. The ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05387278?term=AREA%5BConditionSearch%5D(COVID-19)%20AND%20AREA%5BBasicSearch%5D(placenta-derived%20mesenchymal%20stem%20cells)&rank=2

Safety and Effectiveness of Placental Derived Exosomes and ... Most clinical studies have one primary outcome measure, but some have more than one. ... The main reason for the clinical trial. The types of primary purpose are: ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11056634/

Mesenchymal stem cells and their derived exosomes for ... Mesenchymal stem cells (MSCs) and their derived exosomes (MSCs-Exo) have potent homing abilities, immunomodulatory functions, regenerative repair, and ...

4. withpower.com withpower.com/trial/phase-1-respiratory-distress-syndrome-newborn-4-2022-ebab4

Placental Derived Exosomes and Umbilical Cord ... This trial tests a new treatment using special cells and particles from umbilical cords, given through a drip. It targets hospitalized COVID-19 patients ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8218794/

Umbilical Cord-derived Mesenchymal Stem Cells for COVID ... Transplantation of ACE2- mesenchymal stem cells improves the outcome of patients with COVID-19 pneumonia. ChinaXiv. 2020. doi: 10.12074/202002.00080. [DOI] ...

6. synapse.patsnap.com synapse.patsnap.com/drug/24a6cba91d5542cd960d29bc1f36977f

EV-Pure - Drug Targets, Indications, Patents ... Covid-19. 100 Clinical Results associated with EV-Pure. Login to view more data. 100 Translational Medicine associated with EV-Pure. Login to view more data.

7. 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 ...

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

EV-Pure™ + WJ-Pure™ for Pulmonary Fibrosis This trial tests a combination of two substances, VL-P22 and VL-PX10, given to Covid-19 patients with lung fibrosis.

9. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/smsc.202400606

Native and Engineered Extracellular Vesicles for the ... Clinical trials revealed that nebulized MSC-EVs have good tolerability and short-term safety and do not induce acute or secondary allergic ...