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Clinical Trial Journey

Whether you are gathering information about a potential research study or have just volunteered for a clinical trial, your clinical trial journey is as unique as the reasons behind your choice to participate.

How Many Clinical Study Opportunities Are There?

A big consideration for both researchers and participants is eligibility to participate. Interest and willingness are not the only requirements for eligibility. The ideal clinical trial volunteer will be representative of the eventual patient who will receive the therapy being tested, such as ACP-01 for vascular conditions like Critical Limb Ischemia (CLI) or Peripheral Arterial Disease (PAD). Finding this match between trial and volunteer is important so that reviewers, researchers, clinicians, and governing agencies can have confidence that the trial results will be applicable to the intended patients for the intended condition.

Clinical trial volunteers are essential to further therapy development and research. Our commitment at Hemostemix to understanding the prevalence of vascular diseases in diverse populations helps us deliver patient-centric solutions that offer equitable trial access and enhanced experiences for any participant, in any population group.

This clinical trial journey will take you through some of the typical benchmarks of a trial and provide insights to help you make a decision about whether or not volunteering for a clinical trial is right for you.

Clinical Study Volunteer Experience and Timeline

The clinical trial journey is different for everyone, depending on your current state of health, your age, the type of trial, the duration of the study, and many other factors. Yet in many ways, the standard clinical trial experience is largely the same for most clinical study volunteers. A typical clinical trial timeline—including all visits and what a participant's trial journey looks like from start to finish—involves decisions and engagement opportunities for patients, families, and health care providers at every step of the way.

The various milestones characteristic of a clinical study, which combined, make up the clinical trial participant journey, are explained below.

1. The Screening Visit

When a clinical study volunteer first attends the screening visit for phases 1-3, the clinical trial is explained in detail with opportunities to ask questions.

The study staff will review the informed consent form, which describes the purpose of the clinical research, eligibility, and your rights as a participant. Once you are confident in your decision to participate, you will be asked for your signature and permission to proceed with the screening evaluations. Even if you sign the form at this initial visit, the researchers conducting the study will provide you with the opportunity to take the informed consent form home to discuss it with your family or caregivers before returning it. If you choose to sign and submit your informed consent form on the same day as your screening visit, your clinical trial could begin that day.

In addition to an interview to establish eligibility, the screening visit is designed to provide enough information to enable the researchers to decide with confidence whether you are a good candidate for the given study. No tests can be performed before the informed consent form is signed.

2. The Entry or Baseline Visit

If the screening tests show that you qualify for the clinical trial, the study coordinator will schedule an entry, or baseline visit. In general, the baseline visit takes place after the screening visit since the focus of the screening visit is to establish whether or not a person meets the criteria to participate.

You could be asked to submit to a variety of tests to obtain baseline values before starting your study treatment. These tests may include: height, weight, and BMI (body mass index) measurements; temperature and blood pressure; a urine sample; vital signs and ECG; physical exam; blood samples.

When you attend the baseline visit, you may receive your study therapy, such as ACP-01. The dosing schedule will be reviewed with you along with any other study responsibilities.

3. Clinical Trial Visits

The next set of clinical trial visits make up the study treatment period. At each visit, participants will go through a set of events dictated by the clinical trial protocol. A clinical trial protocol is a document that outlines the standardized objectives and organization of a clinical trial to ensure that the trial can be conducted the same way at each site, and that the trial is safe and ethical.

The number of clinical visits will depend on the specifics and length of the trial. Generally, each visit may include a brief physical exam (with the exception of phase 4 observational studies), a review of your study therapies and your symptoms, and lab tests.

4. The Last Clinical Trial Visit

The last clinical trial visit means that the study treatment period is over. This visit doesn’t always mean the journey’s end; the trial may require follow-up visits. While you will no longer be requested to perform at-home monitoring, you may be asked to check in with the investigator in the weeks and months ahead, and to return to your health care provider for continued treatment and/or checkups.

Participants should ask when the results of their clinical trial will be available, and how they will be informed.

5. The Follow-Up Visit

The clinical study volunteer follow-up visit may take place weeks, months, or rarely, years after the last clinical trial visit.

It is important to note that the follow-up visits for a clinical trial are just as important as the clinical trial visits that took place during the study. In some cases, the loss of participants during the follow-up stage can affect the validity of the study results.

Next Step

Search for active clinical trials or learn more about eligibility.

DisclaimerThe information on this page is for educational purposes only and is not intended as medical advice. Participation in clinical trials involves potential risks and benefits that should be discussed with your healthcare provider. All Hemostemix trials are conducted in accordance with regulatory requirements and ethical standards.

Clinical Trial Phases

What are the phases of clinical trials and how do they differ? Clinical trials are studies involving human subjects that test new treatment methods, new therapies, and methods for measuring the effectiveness of a test treatment on a disease or medical condition. The purpose of clinical trials is to make sure that these new therapies and medical methods are both safe and effective in people.

Clinical Research Phases

Clinical trials follow a particular timeline, from early, small-scale, phase 1 studies to late-stage, large-scale, phase 3 studies. While there are many steps involved in the development of new therapies, clinical trials are the part of therapy development that involves people.

Preclinical Studies

Before a clinical trial begins, researchers perform extensive preclinical studies in the lab to make sure that their methods are not harmful to people. The research in preclinical trials is not performed on people. Instead, potential therapies and the methods to administer them are first tested in cells or animals, or both, long before they make it to human trials.

Phase 1 Clinical Trial

Phase 1 studies test safety in a very small group of healthy volunteers or, for vascular conditions, patients with the condition. Phase 1 determines safety for humans, including side effects, how the body absorbs, distributes, and eliminates the therapy, and whether it is safe in combination with other medications. Approximately 70% of therapies move from phase 1 to phase 2.

Phase 2

Phase 2 clinical trials build on the results of phase 1 by testing the method on participants with the health condition targeted in the study, such as Critical Limb Ischemia (CLI) or Peripheral Arterial Disease (PAD). Researchers evaluate efficacy and safety over a longer period with 100–300 participants. Trials are often randomized, blinded, and placebo- or active-controlled. Approximately 33% of phase 2 studies move to phase 3.

Phase 3

Phase 3 clinical trials are designed to test whether the investigational treatment is better than the standard of care. Usually two or more phase 3 trials are conducted with 300–3,000 participants. These studies are larger, longer, and more definitive. If successful (25–30% of phase 3 studies), the therapy may be submitted for regulatory approval.

Phase 4

Phase 4 clinical trials collect results after a therapy has been approved to monitor long-term benefits and risks in real-world use.

Next Step

Search for active clinical trials or explore our health conditions section.

What is a Clinical Trial?

A clinical trial, or clinical study, is a research study involving human subjects that tests new treatment methods, new therapies, and methods for measuring the effectiveness of a test treatment on a disease or medical condition. Virtually all medical advances happen because of the dedicated volunteers who have taken part in clinical trials.

These carefully planned studies allow scientists to answer questions like: "Does autologous stem cell therapy like ACP-01 improve blood flow better than standard treatments for CLI?" or "Do patients with PAD experience reduced pain after receiving this therapy?"

What is Clinical Research?

Clinical research is a broader term that describes all kinds of research involving people to study the causes of disease and potential interventions or investigative therapies. In all clinical research, researchers may directly or indirectly interact with human tissue, blood, organs, or genes. Clinical trials specifically involve human participants.

Clinical Trials 101

To get an overview of how volunteering for a clinical trial works to move research forward, see Why Participate in a Clinical Trial.

Or, to have a “Clinical Trials 101” experience, including an overview of what a clinical trial is really like, explore the Clinical Trial Journey guide.

Next Step

Search for active clinical trials today.

Why Participate in a Clinical Trial?

Whether you are a healthy volunteer or a patient, the reasons why you may want to participate in a clinical trial are diverse. Healthy volunteers often say that they participate to help others and to contribute to scientific progress. Participants with a certain illness also want to help others, but also may want to receive investigational treatment and the care and attention of the doctors and other personnel running the trial.

There are also significant risks in participating in clinical trials, such as unexpected or unwanted side effects or ineffective treatment. However, the central goal of clinical trials is to improve current treatment options for patients through designed experimentation.

Importance of Clinical Research in Medicine

Every single clinical trial is crucial to advancing research that can lead to new therapies, cures, and interventions to benefit patients and families. Even failed trials provide a tremendous amount of data that transforms future efforts.

The importance of clinical research in medicine can be measured by a trip to your local clinic. From standard vascular treatments to innovative stem cell therapies like ACP-01, many products available for everyday use came as the result of a clinical trial.

Are Clinical Trials Important?

In every clinical trial, the patient is the priority. Research protocols and results are only as good as the care that each clinical trial patient receives. Without patients and healthy volunteers, we would be without much of the groundbreaking research that has transformed modern health care.

Virtually experience a Clinical Trial Journey.

Next Step

Search for active clinical trials or learn more about our health conditions.

Are Clinical Trials Safe?

Clinical trials are designed with participant safety as the top priority. At Hemostemix, all trials follow strict protocols approved by regulatory bodies like the FDA and Institutional Review Boards (IRBs) to minimize risks. However, like any medical procedure, there are potential risks, which are carefully monitored and disclosed.

How Safety is Ensured

Before a trial begins, extensive preclinical testing occurs. During the trial:

Participants are monitored closely for side effects at every visit.
Independent data safety monitoring boards review ongoing results.
Trials can be stopped or modified if safety concerns arise.
Informed consent ensures you understand all known risks and benefits before agreeing to participate.

For stem cell therapies like ACP-01, safety data from prior studies shows promising results, but individual experiences may vary.

Common Safety Measures

Trials include regular check-ins, lab tests, physical exams, and follow-ups to track health. If you're concerned about safety, discuss openly with the study investigator or your own doctor.

Next Step

Explore our FAQs or search for active clinical trials.

What to Expect in a Clinical Trial

Participating in a Hemostemix clinical trial involves structured steps to ensure your comfort, safety, and understanding. From screening to follow-up, here's what you can typically expect.

Key Stages

Screening: Initial assessments to check eligibility, including medical history review, physical exam, and laboratory tests.
Treatment Phase: Receiving the study therapy (such as ACP-01) or placebo/control, with scheduled visits for monitoring, additional tests, and symptom reviews.
Follow-Up: Post-treatment check-ins (weeks to months later) to track long-term effects and overall health.

What Participation Involves

Expect thorough explanations at every step, potential travel to study sites, regular communication with the study team, and the right to withdraw at any time without penalty. Some trials offer compensation for time and travel expenses.

Tips for Preparation

Bring a list of questions, involve family or caregivers if helpful, and carefully review the informed consent document. Your rights as a participant are protected throughout the process.

Next Step

Search for active clinical trials or contact us for more information.

Resources for Clinical Trial Participants

Clinical Trial Journey

Clinical Trial Phases

What is a Clinical Trial?

Why Participate in a Clinical Trial?

Are Clinical Trials Safe?

What to Expect in a Clinical Trial

Learn About Hemostemix Clinical Trials