There are several phases (I-IV) of a clinical trial, which represent the progression of testing for a novel drug or therapy. Each phase has specific goals and builds upon the previous one, with increasing numbers of participants and more comprehensive data collection. This progressive research ensures treatments are thoroughly tested for safety and efficacy prior to approval for commercial availability.

A Phase I clinical trial is the first test of a new drug in a small number of humans to determine drug safety and dosage. In a Phase II clinical trial, the treatment is tested in a larger number of participants to measure potential efficacy and side effects, while still observing safety. A Phase III clinical trial compares the safety and efficacy of the new drug against current standard treatments. Phase IV clinical trials are conducted once the drug is approved by the FDA during the Post-Market Safety Monitoring period.

For more information, please see the "Clinical Trial Phases" resource below.

Immunis’ investigational therapy (IMM01-STEM) is being studied in a USA FDA clinical trial process and is not commercially available. However, you may be eligible to receive our therapy if you qualify for one of our active clinical trials.

The clinical trials are performed at accredited clinical research facilities that are independent from Immunis Inc. Immunis is not involved with the screening or selection of participants to take part in the clinical trials. If you are interested in participation, we recommend that you first review the inclusion and exclusion criteria (see "Phase 2 STEM-META Inclusion Criteria" resource below), where you will also be able to find a clinical site nearest you to discuss the next steps.

For additional information, please see the "Phase 2 STEM-META Clinical Trial" resource below.

You might! To ensure patient safety and accuracy of the research data, each clinical trial has a strict set of eligibility criteria to participate. Only participants who satisfy all inclusion criteria and none of the exclusion criteria are eligible. The qualifications are different for each trial so please refer to our "Phase 2 STEM-META Inclusion Criteria" resource below. Also, please note that if you have already participated in one of these trials, you may not participate in a second trial.

Clinical trials can range from several months in the early phases to several years in the later phases. The time commitment will vary based on the type of clinical trial, which is designed for a particular disease indication with safety and efficacy in mind.

The clinical trial enrollment process typically begins with a comprehensive pre-screening phase, which includes obtaining the patient's medical history from their primary care physician and conducting additional laboratory tests as needed. The process continues with additional screening, treatment, and safety follow up.

For more information, please see the "Phase 2 STEM-META Clinical Trial" resource below.

The clinical trials are designed in accordance with HIPAA regulations as defined by the U.S. Department of Health and Human Services. Additionally, all collaborating institutions and hospitals researching and testing IMM01-STEM are HIPAA compliant to ensure the safety and privacy of each participant.

No, participation in a clinical trial is free. You may even be reimbursed for your time.

No. You or your healthcare insurance (including healthcare coverage programs such as Medicare or Medicaid) will NOT be charged for any tests or treatments that are part of the clinical trial. As a result, it is not necessary for you to have healthcare coverage to participate.

No. IMM01-STEM is a new treatment that is still being tested in FDA-approved clinical trials to ensure safety and efficacy. It is not available as a commercial product. IMM01-STEM is not approved for any clinical applications.

For more information, please see the "Clinical Programs" resource below.