Autologous Angiogenic Cell Precursors (ACPs) for the Treatment of Peripheral Artery Disease

NCT01584986 | Completed Phase 2

• 1 other identifier: ACP_CLI_P01
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

Brief Summary

Regeneration of the occluded peripheral arteries by autologous stem cell therapy is an emerging treatment modality for no-option patients with peripheral artery disease (PAD). The purpose of this study was to assess safety and efficacy of ex vivo expanded, peripheral blood-derived, autologous angiogenic cell precursors (ACPs) in no-option PAD patients.

Conditions

Critical Limb Ischemia

Outcome Measures

Primary Outcomes (6)

• Safety

  Evaluation the safety of ACPs intramuscular injection

  3 months

• Rest pain

  3 months

• Pain-free walking distance

  3 months

• Ulcer size

  3 months

• Gangrene dimension and intensity

  3 months

• Obtain evidence for improvement of tissue perfusion due to ACPs injection

  3 months

Secondary Outcomes (2)

• Reduction of CLI patients hospitalization time

  3 months

• Decrease CLI patient amputation rate

  3 months

Study Arms (2)

ACP treated

ACTIVE COMPARATOR

Autologous angiogenic cell precursors (ACPs) were injected into the ischemic gastrocnemius muscle in addition to the conventional treatment.

Biological: ACP injections

Control

NO INTERVENTION

Control patients were treated with the conventional therapy.

Interventions

ACP injections BIOLOGICAL

Peripheral blood-derived, ex vivo expanded autologous angiogenic cell precursors (ACPs)

ACP treated

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects having one or more clinical indications diagnostic of CLI such as: distal extremity pain at rest that requires the subject to use analgesics for \> 2 weeks; or peripheral ischemic ulcer(s); or areas of gangrene ; or non-healing ischemic ulcers; and
• Subjects having one or more of the following hemodynamic indicators of severe peripheral arterial occlusive disease: I. Ankle brachial index ≤ 0.45 or II. Toe brachial index ≤ 0.35 or III. TcPO2 / TcO2 of ≤ 40 mmHg.
• The subject being a poor candidate for standard revascularization treatment options for peripheral arterial disease, based on inadequate bypass conduit, or unfavorable anatomy;
• Age 18 to 80 years;
• Male or non-pregnant, non-lactating female;
• Informed consent obtained and consent form signed.

You may not qualify if:

• Patient having on angiography a meaningful supra-popliteal occlusion that may relate to symptoms of CLI;
• Subjects, who in the opinion of the investigator, have a vascular disease prognosis that indicates they would require a major amputation (at or above the ankle) within 4 weeks of start of treatment;
• Patient who received blood transfusions during the previous 4 weeks (to exclude the potential of non-autologous ACPs in the harvested blood);
• Inability to communicate (that may interfere with the clinical evaluation of the patient);
• Major operation during the preceding 3 months;
• Myocardial infarction or brain infarction or uncontrolled myocardial ischemia or persistent severe heart failure (EF\< 25 %) during the preceding 3 months;
• Significant valvular disease or after valve replacement;
• After heart transplantation;
• Cardiomyopathy;
• Renal failure (creatinine \> 2 mg/dl );
• Hepatic failure;
• Anemia (lower than 11 mg/dl hemoglobin for female and lower than 12 mg/dl for male);
• Abnormal coagulation tests \[platelets, PT (INR), PTT\];
• Stroke within the preceding 3 years;
• Malignancy within the preceding 3 years;

Sponsors & Collaborators

• Salus Ltd.: lead
• TheraVitae Ltd.: collaborator

Study Sites (2)

Kelen Hospital

Budapest, Hungary

Location

Semmelweis University Department of Cardiovascular Surgery

Budapest, Hungary

Location

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Officials

• György Acsády, DSc

  Semmelweis University Department of Cardiovascular Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2012
• First Posted: April 25, 2012
• Study Start: May 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: July 1, 2009
• Last Updated: April 25, 2012

Record last verified: 2012-04

Locations

HU (2)