Back to results

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

Primary Purpose

Critical Limb Ischemia

Status

Completed

Phase

Phase 2

Locations

Hungary

Study Type

Interventional

Intervention

ACP injections

About this trial

This is an interventional treatment trial for Critical Limb Ischemia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)Does not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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;
Concurrent chronic or acute infectious disease;
Severe concurrent medical disease (e.g., septicemia, HIV-1,2/HBV/HCV infections, poorly controlled insulin-dependent diabetes mellitus; HbAlc > 8% and proliferative retinopathy, systemic lupus erythematosus, multiple sclerosis, amyotrophic lateral sclerosis);
Chronic immunomodulating or cytotoxic drugs treatment;
Patients who have rectal temp. above 38.4 ºC for 2 consecutive days;
Patient unlikely to be available for follow-up.

Sites / Locations

Kelen Hospital
Semmelweis University Department of Cardiovascular Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

ACP treated

Control

Arm Description

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

Control patients were treated with the conventional therapy.

Outcomes

Primary Outcome Measures

Safety

Evaluation the safety of ACPs intramuscular injection

Rest pain

Pain-free walking distance

Ulcer size

Gangrene dimension and intensity

Obtain evidence for improvement of tissue perfusion due to ACPs injection

Secondary Outcome Measures

Reduction of CLI patients hospitalization time

Decrease CLI patient amputation rate

Full Information

NCT ID

NCT01584986

First Posted

April 24, 2012

Last Updated

April 24, 2012

Sponsor

Salus Ltd.

Collaborators

TheraVitae Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01584986

Brief Title

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

Official Title

Autologous Stem Cell Therapy for the Treatment of Patients With Peripheral Artery Disease

Study Type

Interventional

2. Study Status

Record Verification Date

April 2012

Overall Recruitment Status

Completed

Study Start Date

May 2008 (undefined)

Primary Completion Date

April 2009 (Actual)

Study Completion Date

July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Salus Ltd.

Collaborators

TheraVitae Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

Late-stage no-option PAD patients with a high risk of amputation of the affected limb were enrolled and randomized into treated and control groups. In the 10 ACP treated patients the stem cells were injected into the ischemic gastrocnemius muscle. The 10 control patients were treated with the conventional therapy. Physical examination, a treadmill walking test were performed, ankle brachial index (ABI), transcutaneous oxygen pressure (TcO2) were measured at baseline, 1 and 3 months later. Digital substraction angiography and SF-36 quality-of-life (QoL) questionnaire were also performed at baseline and 3 months later.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Critical Limb Ischemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ACP treated

Arm Type

Active Comparator

Arm Description

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

Arm Title

Control

Arm Type

No Intervention

Arm Description

Control patients were treated with the conventional therapy.

Intervention Type

Biological

Intervention Name(s)

ACP injections

Intervention Description

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

Primary Outcome Measure Information:

Title

Safety

Description

Evaluation the safety of ACPs intramuscular injection

Time Frame

3 months

Title

Rest pain

Time Frame

3 months

Title

Pain-free walking distance

Time Frame

3 months

Title

Ulcer size

Time Frame

3 months

Title

Gangrene dimension and intensity

Time Frame

3 months

Title

Obtain evidence for improvement of tissue perfusion due to ACPs injection

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Reduction of CLI patients hospitalization time

Time Frame

3 months

Title

Decrease CLI patient amputation rate

Time Frame

3 months

10. Eligibility

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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; Concurrent chronic or acute infectious disease; Severe concurrent medical disease (e.g., septicemia, HIV-1,2/HBV/HCV infections, poorly controlled insulin-dependent diabetes mellitus; HbAlc > 8% and proliferative retinopathy, systemic lupus erythematosus, multiple sclerosis, amyotrophic lateral sclerosis); Chronic immunomodulating or cytotoxic drugs treatment; Patients who have rectal temp. above 38.4 ºC for 2 consecutive days; Patient unlikely to be available for follow-up.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

György Acsády, DSc

Organizational Affiliation

Semmelweis University Department of Cardiovascular Surgery

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kelen Hospital

City

Budapest

Country

Hungary

Facility Name

Semmelweis University Department of Cardiovascular Surgery

City

Budapest

Country

Hungary

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs