VL-PX10 and VL-P22 are a first-in-class proprietary combination therapy of human Umbilical Cord Mesenchymal Stem Cell Exosomes, Mesenchymal Stem Cells, and their biomaterials. This product is currently in a Phase 2 human clinical trial open to patients in the United States.

What is a Clinical Trial?

Clinical Trials are research studies that test a medicine, device, or therapeutic intervention in people. These trials are the primary way that researchers determine if a new form of treatment or prevention is safe and effective in people. In addition, clinical trials may be used to test ways to diagnose a disease early, find new approaches to prevent health problems or improve the quality of life for people living with life-threatening diseases or chronic health problems.

Why Should I Participate in a Clinical Trial?

There are many reasons why people volunteer to participate in a clinical trial. Some want to contribute to the discovery of health information that may help others in the future; others may participate to play a more active role in their health, while others may participate to have access to treatments for health problems where current treatment options have failed, or no treatment option is available. Whatever the motivation, when the choice is made to participate in a clinical trial, the patient becomes a partner in the scientific community and an active participant in improving the world. Participating in research can help future generations lead healthier lives. Major medical breakthroughs could not happen without the generosity of clinical trial participants. So, at Vitti Labs™, we thank all who consider being a part of this trial.

How Does a Typical Clinical Trial Work?

  • Research staff explain the trial or study in detail, answer questions, and gather more information about potential participants.
  • Once participants agree to the study, they must sign an informed consent indicating their understanding of what to expect as a participant and the possible outcomes.
  • Participants are screened to ensure qualification for the trial or study.
  • If accepted into the trial, a first visit, called the “baseline” visit, is scheduled. The researchers conduct cognitive and/or physical tests during this visit.
  • For some trials, participants are assigned by chance (randomly) to a treatment group or a control group. The treatment group will get the intervention being tested, and the control group will not.
  • Participants follow the trial procedures and report any issues or concerns to researchers.
  • Participants may attend regularly scheduled visits for new cognitive, physical, or other evaluations and discussions with staff. The research team collects data during these visits and monitors safety and well-being.
  • Participants continue to see their regular physician(s) for usual health care throughout the study.

*If participation in this clinical trial is not available due to exclusion criteria or circumstance see the Expanded Access Program (EAP) option below.

What is the Expanded Access Program (EAP)?

The Expanded Access Program allows patients with severe or life-threatening illnesses to receive investigational medications outside of clinical trials. This program provides access to these medications, which have not yet been approved by the FDA, when no other approved treatment options are available. Patients eligible for this program may have already tried and failed approved medications or be unable to take currently available medications due to side effects or contraindications. Additionally, expanded access programs cater to situations where no clinical trials are available in the area, or the patient does not meet the eligibility criteria for such trials. By granting access to investigational medications, these programs offer a compassionate approach to providing options to patients who have exhausted all other alternatives for their conditions.

Patients who suffer from Pulmonary Fibrosis from Long Haul COVID who are not eligible to participate in the ongoing clinical trial may request this combination cellular therapy through the Expanded Access Program. Vitti Labs™ has met the requirements to make VL-PX10 and VL-P22 available to treat Pulmonary Fibrosis in Long Haul COVID patients through the EAP.

Physicians can apply for expanded access on behalf of their patients to utilize the therapy VL-PX10 and VL-P22, along with the provided protocol. Once enrolled, Vitti Labs™ will supply the Physician with the product, guidelines, and instructions. Physicians must provide IV administration supplies, including saline, tubing, and administration equipment.

*Physician Use Ony

How the Expanded Access Program (EAP) Works


Physician Applies for Expanded Access through Vitti Labs™ [ APPLY HERE ]


Physician fills out paperwork from Vitti Labs™ and the FDA

Paperwork includes: NDA, FDA Application for EAP, and Investigator Brochure


Physician submits paperwork to Vitti Labs™ and the FDA


Typical wait time for approval or denial response from the FDA is 24-72 hours

If Approved by the FDA

  • The Applicant (Physician) will follow up with Vitti Labs™ to communicate the response from the FDA

  • The Physician may obtain the therapy through the Expanded Access Program from Vitti Labs™

  • Vitti Labs™ sends the Physician the therapy and associated paperwork to complete

  • The Physician administers the therapy to the patient according to protocol provided

  • The Physician completes provided paperwork and submits back to Vitti Labs™

If Denied by the FDA

  • The Applicant (Physician) will follow up with Vitti Labs™ to communicate the response from the FDA

Apply Today

If you are a Physician that has a patient who wishes to participate please apply.

*Physician Use Ony