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Join A New Trial for Critical Limb Threatening Ischemia.

Investigate the Possibility of Preventing Lower Limb Amputation.

If you have been diagnosed with Critical Limb Ischemia, you may be eligible for a new clinical trial happening in your area.

Become a VesCell Trial Participant
Hemostemix is currently recruiting patients to participate in the VesCell (ACP-01) Phase I clinical study for Critical Limb Threatening Ischemia, which is facing a lower limb amputation, or reducing ulcers, wounds and pain associated with Peripheral Arterial Disease. 
The trial will help to evaluate the safety and efficacy of an investigation stem cell therapy (ACP-01) derived from a simple blood draw.
Hemostemix hopes to bring relief to patients and their families through this study.
All information is kept private and follows all HIPAA guidelines.

View the clinical study details at http:www.clinicaltrials.gov

A New Path for No-Option Critical Limb Ischemia

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.

Reach a Care Team Navigator
What does “No option” mean?

“No option” patients are those without suitable surgical revascularization options, and often face major amputations, or severe morbidity (Angina, or Cardiomyopethy).

What are the signs of Critical Limb Ischemia?

Symptoms of peripheral arterial disease, pain while at rest, or gangrene.

Participation Eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate.

There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Participating Locations

Study status can change often. Please contact the study team for the most up-to-date information regarding possible participation.

The Metropolitan Neurosurgery Group
Phone: 301.557.9049
Fax: 301.654.9394
1401 Mercantile Ln, Suite #341
Upper Marlboro, MD 20774

Lab Process for Hemo

Understanding Critical Limb Threatening Ischemia, and Peripheral Arterial Disease

Learn more about what CLI is, from diagnosis to treatment.

Learn More about Critical Limb Threatening Ischemia

 

Share Your VesCell Story

Share your experience with Vscell to help inform and inspire others.  To participate please email support@vescell.health or call 540-878-6754

 

Your Dedicated Care Team Navigator

Your VesCell Care Team Navigator is committed to getting to know you and your individual needs.

Get to know your Ambassador

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Thomas Smeenk

CEO, Hemostemix

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“Listen to a Patient treated with ACP-01 for Vascular Dementia 10 Years Post-Treatment,” stated Thomas Smeenk, CEO, Hemostemix.  “Mrs. L lost her daily function-abilities and was to be admitted to a long-term care facility. Ten years after ACP-01 treatment, in 12 minutes, she discussed her career path, family-raising-time, wonderful second marriage, ability to drive, and the benefits of ACP treatment including no longer suffering from ocular migraines. Then she scheduled a lunch appointment with the physician who treated her for vascular dementia, to celebrate her cognitive health ten years post treatment,” Smeenk continued. “With BNA™’s readouts of ACP’s impacts, I predict Hemostemix and Firefly will set the objective standard for the successful diagnoses and treatment of vascular dementia. Families who have a loved-one who are suffering from vascular dementia may contact me (tsmeenk@hemostemix.com), to understand the assessment, inclusion and exclusion criteria,” Smeenk said.

Brooklyn Customer
Brooklyn Simmons

Director

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I highly recommend the products and services provided by this organization. I never feel alone in my journey while working with them. You can undoubtedly initiate with them.

Brooklyn Customer
Brooklyn Simmons

Director

quotes-img

I highly recommend the products and services provided by this organization. I never feel alone in my journey while working with them. You can undoubtedly initiate with them.

Brooklyn Customer
Brooklyn Simmons

Director

quotes-img

I highly recommend the products and services provided by this organization. I never feel alone in my journey while working with them. You can undoubtedly initiate with them.

Brooklyn Customer
Brooklyn Simmons

Director

quotes-img

I highly recommend the products and services provided by this organization. I never feel alone in my journey while working with them. You can undoubtedly initiate with them.

All Vascular Studies

with Autologous Stem Cells (ACP-01)

Phase 1 Study

Limb Amputation

Chronic Limb Threatening Ischemia (CLTI) without other options.

Phase I Study

Peripheral Artery Disease (PAD)

Phase I Study

Severe Angina

Chronic stable angina without other options.

Phase II Study

Cardiomyopathy

No option ischemic and non-ischemic dilated cardiomyopathy

Phase I Study

Vascular Dementia 

Cognitive impairment following a stroke

How does VesCell work?

Find
VesCell migrates to areas of decreased blood flow (Ischemia)
Embed
VesCell embeds into injured tissues and repopulates injured tissue.
Release
VesCell releases growth factors and reduces inflammation.
Generate
Generates new blood vessels to improve blood flow.
MOA

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.