Restoring Flow Renewing Hope
VesCell is an investigational therapy for No-Option Cardiovascular Disease including Heart, Limb and Dementia Care
*VesCell is not FDA approved and not available in the United States
Learn about VesCell (ACP-01)
VesCell (ACP-01) is an investigational stem cell therapy that may offer hope through clinical trials, expanded access, and compassionate use programs.
VesCell may improve blood flow using a patient’s own cells from a simple blood draw. See the data.
VesCell is for people with severe leg pain from poor blood flow, chest pain from heart issues or heart weakness, or vascular dementia who have no other treatment options.
Interested in participating in a clinical study?
Now Available: A New Path for No-Option CLI
For those facing critical limb ischemia (CLI) with no other treatment options, VesCell offers hope.
This investigational autologous stem cell therapy is designed to improve blood flow in the lower legs and feet, heal ulcers, and reduce the risk of amputation and mortality.
Critical limb ischemia (CLI) is a subset of Peripheral Artery Disease (PAD).
Backed by Phase II clinical trial data, VesCell is an investigation treatment for patients with severe CLI.
Results from Phase II Trials
- 67% Ulcer Size Reduction
In just 3 months, VesCell reduced ulcer size by 67% (p = 0.01) in patients with no-option CLI.
- 4.8% Amputation Rate Reduction
Compared to 25% in the placebo group, VesCell lowered amputation rates significantly.
- 4.8% Mortality Rate Reduction
VesCell reduced mortality to 4.8% compared to 12.5% in the placebo group at one year.
Data from Phase II ACP NO-CLI Trial. VesCell is investigational and not FDA-approved.
Is VesCell Right for You?
If you or a loved one have no-option CLI with non-healing ulcers, VesCell may offer hope through our Expanded Access Program or clinical trials.
Take the first step to learn more and see if you qualify for this investigational therapy.
Call our toll-free number: 1-800-VESCELL or send an email to support@vescell.health
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Important Safety Data
- VesCell (ACP-01) is an investigational therapy under development, not approved by the FDA, and only available in specific countries.
- Treatments are subject to health regulations in Canada, Bahamas, Dominican Republic, and Switzerland, and not US FDA oversite.
- Canada’s Special Access program allows unapproved treatments for serious conditions when conventional therapies have failed.
- U.S. Patients travel at their own risk for treatments received abroad.
- US Patients should consult with their physicians before seeking treatment abroad.
- Treatments are generally out of pocket expenses and may not be covered by US insurance.
Treatment Risk Information
Angiogenic Precursor Cell Treatment of Critical Limb Ischemia Decreases Ulcer Size, Amputation and Death Rate: Re-Examination of phase II ACP NO-CLI Trial Data
Fraser C Henderson*, Ina Sarel, Kelly Tuchman, Stephen Lewis and York Hsiang
Volume5-Issue2
Dates: Received: 2024-01-18 | Accepted: 2024-02-01 | Published: 2024-02-02
Pages: 092-105
Abstract
Introduction: Critical limb ischemia has a prevalence in the US of 1.33%, with mortality 15-20% and major amputation 10-40% per year. Stem cell treatment has emerged as a treatment option for the 45% of patients for whom revascularization procedures are not possible.
Objective: This study re-examines the data of the Phase II clinical treatment of no option Critical limb ischemia with Hemostemix’ angiogenic cell precursors, focusing upon ulcer wound healing, amputation and death rate of this cohort.
Methods: Primary endpoints were changes in ulcer size and major amputation or death within one year of treatment. The secondary endpoint was change in pain level.
Results: From 2015 to 2021, 67 patients with no option Critical limb ischemia were allocated to treatment with ACP-01 (46/67) or placebo (21/67). From this data, only patients who presented with wound ulcers before administration of ACP-01 were reviewed (21 treatment, 8 placebo). Ulcer size in the treated group decreased from a mean of 1.46 cm2 to 0.48 mm2 (p = 0.01) by 3 months. There was no significant decrease in the size of the ulcers of the placebo group (p < 0.54). At one year there were no complications related to treatment. The treatment group had one amputation (4.8%) and one death (4.8%); the placebo group had 2 amputations (25%) and 1 death (12.5%). Change in pain was not significant in either group at 3 months, but at 1 year was improved in the placebo group (p = 0.01).
Conclusion: The administration of ACP-01 within a program of careful patient follow up is safe and associated with reduced ulcer size and decreased rate of amputation and death. Consideration should be given to re-administration of stem cell treatments every 3-6 months to optimize improvement of Critical limb ischemia. Further studies, more appropriately powered, are warranted.