When you are making a decision about an investigational therapy, you deserve to see the research, not a summary of it. Not a marketing claim. The actual numbers, with the honest context that explains what they mean and what they do not mean.
This article gives you that. ACP-01 has been studied in 490 patients across seven published peer-reviewed clinical trials. Here is what those studies found.
The Foundation: Seven Published Studies
ACP-01 has been evaluated in the following conditions across seven clinical trials: no-option Critical Limb-Threatening Ischemia (CLTI), severe refractory angina, ischemic cardiomyopathy, and dilated cardiomyopathy. All studies have been published in peer-reviewed medical journals.
The clinical institutions involved include Vancouver General Hospital, UCLA and Cedars-Sinai Medical Center, Penn State College of Medicine, University of Toronto, and international centres in Thailand and Europe.
Results in No-Option CLTI: The Leg Artery Disease Data
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Phase II Randomized Controlled Trial (Henderson et al., Vancouver General Hospital) Patient population: No-option CLTI patients with Rutherford Class 5 and 6 disease (active tissue loss and gangrene). Sub-analysis of patients with active ulceration at baseline. 95.2% limb salvage at 12 months in the ACP-01 group, versus 75% in the placebo group 95.2% survival at 12 months in the ACP-01 group, versus 87.5% in the placebo group 81% relative risk reduction in major amputation 83% of patients maintained outcomes when followed for up to 4.5 years Wound size reduced from a mean of 146 mm² to 0.48 mm² at 3 months: from the size of a wild strawberry to the size of a grain of sand Zero treatment-related serious adverse events Zero treatment-related deaths |
Results in Severe Angina: The Chest Pain Data
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Study: Damras et al. (N=24, intracoronary delivery) Angina pain score (CCS scale) cut in half: from 2.1 to 1.05 at 3 months (p<0.001) Walking distance improved from 333 to 414 meters at 3 months (p<0.001) The portion of the heart not receiving adequate blood flow fell from 38% to 21% at 6 months (p<0.005) |
Results in Ischemic Cardiomyopathy and Heart Failure
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Study 1: Chaithiraphan et al. (N=106, intracoronary delivery) Angina pain score improved from 2.63 to 1.53 (p<0.001) Heart failure functional class improved from 2.69 to 1.64 at 8-12 months (p<0.001) Heart pumping function (ejection fraction) improved from 34.4% to 39.1% at 2-4 months (p<0.05) |
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Study 2: Schubart et al. (N=54, transcatheter delivery) Heart pumping function improved from 28.6% to 36.29% at 12 months (p=0.003), a 26.88% relative improvement Patients with the weakest hearts (pumping function below 20%) saw the greatest gains: from 14.6% to 28.4% 66% of patients reported quality of life improved. 28% reported unchanged. 6% reported worse. Zero treatment-related serious adverse events |
What This Data Does and Does Not Mean
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Context you need to interpret these numbers honestly: The CLTI results are from a Phase II randomized controlled trial sub-analysis, not a large Phase III trial. Phase II trials are designed to assess safety and early efficacy signals. They are meaningful, but they are not the same standard of evidence required for regulatory approval. The cardiac studies are Phase I and Phase II open-label studies. They are the evidence base that justifies continued investigation, not the evidence base for approval. ACP-01 is investigational and not approved by Health Canada, the FDA, or any other regulatory authority for any condition. Individual outcomes cannot be predicted. Not all patients respond. |
What this data does represent is a peer-reviewed, independently published, multi-institution body of evidence that has established the safety profile of ACP-01 and provided meaningful signals of efficacy across multiple ischemic conditions. It is the basis on which responsible clinical evaluation continues.
For patients who have exhausted conventional options, understanding what this research shows is not false hope. It is accurate information, placed in your hands at the moment you need it.
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Speak with our clinical team The Hemostemix clinical team can review your specific history and imaging and tell you honestly whether you may be a candidate for evaluation in the ACP-01 research program. Email: clawrence@hemostemix.com Call: +1 (239) 341-5842 Book: hemostemix.com/book-croom |
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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. |