---
title: Am I Eligible for ACP-01? What Patients Need to Know
description: Who is eligible for ACP-01 investigational therapy? Learn which patients have been studied in clinical trials, what the evaluation involves, and how to request an assessment from the Hemostemix clinical team.
---

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# Am I Eligible for ACP-01? What Patients Need to Know

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[Hemostemix](https://hemostemix.com/hemostemix-library/author/admin)  Mar 22, 2026, 9:01:42 AM

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After reading about ACP-01, most patients arrive at the same question: does this apply to me?

It is the right question to ask, and this article is here to answer it as honestly as possible. ACP-01 is investigational, which means access is through specific regulated pathways and eligibility is assessed individually. Not every patient who contacts us will be a candidate. But understanding who has been studied, and what the evaluation involves, tells you whether it is worth taking the next step.

 

## Who Has Been Studied in ACP-01 Clinical Research

---

 

The clinical trials of ACP-01 have focused on patients with the following characteristics. This is not a checklist for automatic eligibility. It is a description of the patient populations that have been evaluated and shown the most meaningful clinical signals.

- **Leg artery disease:** Advanced Peripheral Artery Disease (PAD) or Chronic Limb-Threatening Ischemia (CLTI)
- Prior failed revascularization attempts, including bypass surgery, angioplasty, or stenting that did not provide durable benefit
- Classification as no-option CLTI: no viable target vessel for further surgical or catheter-based intervention
- Active non-healing wounds on the foot or lower leg
- Rutherford Class 5 or 6 disease (the most advanced stages, characterized by active tissue loss and gangrene)
- **Cardiac patients:** Refractory angina that has not responded to medications, stenting, or bypass surgery
- Ischemic or dilated cardiomyopathy (weakened heart muscle from poor circulation)

## What the Evaluation Process Involves

---

 

No patient is accepted into an ACP-01 program without a thorough individual evaluation. Here is exactly what that process looks like.

- An initial conversation with the Hemostemix clinical team, either by phone or email, to discuss your history and current condition
- A review of your existing medical records, imaging, and prior treatment history
- A determination by the Hemostemix clinical physician team of whether your anatomy, disease stage, and medical status suggest you may be a candidate
- If you are considered a potential candidate, a detailed discussion of the treatment process, realistic expectations, risks, access pathway, and costs
- Informed consent and physician consultation before any treatment proceeds

You can stop the process at any point. If the clinical team determines you are not a candidate, they will tell you that directly, along with any other options they are aware of that may be relevant to your situation.

 

## Where ACP-01 Is Currently Available

---

 

Because ACP-01 remains investigational, access is through specific regulated pathways:

- Florida, USA, under Senate Bill 1768, which permits physician-supervised access to investigational therapies for eligible patients
- Toronto, Canada, through compassionate access pathways
- The Bahamas and Dominican Republic, through international research and access programs

## The Honest Answer to the Eligibility Question

---

 

Not every patient who contacts us is a candidate. The clinical team evaluates each case individually and will give you an honest answer based on your specific situation.

What we can say is this: if you have advanced PAD, CLTI, a non-healing wound, refractory angina, or heart failure that has not responded to standard treatment, the conversation is worth having. The evaluation costs you nothing but time.

 

| **Speak with our clinical team** If you want to find out whether you may be eligible for evaluation in the ACP-01 research program, our clinical team reviews every inquiry personally. We will tell you honestly what we see in your situation and whether we believe we can help. **Email:** [careteam@hemostemix.com](mailto:careteam@hemostemix.com) **Call:** 888-396-2402 |
| --- |

 

| **Disclaimer:** *ACP-01 is investigational and not approved by Health Canada, the FDA, or any other regulatory authority. This article is educational only and does not constitute medical advice. Individual outcomes vary. Always consult your physician before making any treatment decisions.* |
| --- |

 

| **Hear From Someone Who Has Been There** *Two patients. Two diagnoses. Two decisions that changed everything.* [**Half of His Heart Died in That Attack. The Other Half Had Other Plans.**](https://hemostemix.com/hemostemix-library/half-of-his-heart-died-in-that-attack.-the-other-half-had-other-plans) [**He Was Told He Needed Open-Heart Surgery. He Chose a Different Path. That Was 15 Years Ago.**](https://hemostemix.com/hemostemix-library/he-was-told-he-needed-open-heart-surgery.-he-chose-a-different-path.-that-was-15-years-ago) |
| --- |

 

[All Articles](https://hemostemix.com/health-hub-blog) [PAD](https://hemostemix.com/blog-peripheral-arterial-disease) [CLTI](https://hemostemix.com/blog-peripheral-arterial-disease) [Cardiovascular Ischemia](https://hemostemix.com/blog-cardiovascular-ischemia-angina) [Angina](https://hemostemix.com/blog-cardiovascular-ischemia-angina) [Vascular Dementia](https://hemostemix.com/blog-vascular-dementia) [ACP-01](https://hemostemix.com/blog-autologous-stem-cell-therapy) [Wound Care](https://hemostemix.com/blog-wound-care) [Patient Stories](https://hemostemix.com/blog-patient-stories) [Funding & Access](https://hemostemix.com/blog-funding-access)

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