Critical Limb IschemiaPhase 2NCT01584986

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

A Phase 2 study testing ACP injections in people with Critical Limb Ischemia, run by Salus Ltd. at 2 sites in Hungary.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Any age
Conditions the study is for: Critical Limb Ischemia
What is being tested?: ACP injections
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 2 sitesHungary
Study dates: May 2008to Jul 2009
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

Show all 20Show fewer

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.

Trial locations and contacts

2 sites in 1 country.

Hungary2 sites

Kelen Hospital
Budapest
Semmelweis University Department of Cardiovascular Surgery
Budapest

Other trials in Hungary

About this study

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

Read the 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.

Conditions: Critical Limb Ischemia
Being tested: ACP injections
Medical subject headings: Chronic Limb-Threatening Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01584986
Study group	Role	What they receive
ACP treated	Active comparator	Autologous angiogenic cell precursors (ACPs) were injected into the ischemic gastrocnemius muscle in addition to the conventional treatment. Receives: Biological: ACP injections
Control	No intervention	Control patients were treated with the conventional therapy.

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety
Evaluation the safety of ACPs intramuscular injection
Measured: 3 months
Rest pain
Measured: 3 months
Pain-free walking distance
Measured: 3 months
Ulcer size
Measured: 3 months
Gangrene dimension and intensity
Measured: 3 months
Obtain evidence for improvement of tissue perfusion due to ACPs injection
Measured: 3 months

Secondary outcomes (2)

Reduction of CLI patients hospitalization time
Measured: 3 months
Decrease CLI patient amputation rate
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2008Jul 2009

First posted25 Apr 2012 (estimated)
Study startMay 2008
Primary completionApr 2009
Study completionJul 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Critical Limb IschemiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01584986
Sponsor's protocol ID: ACP_CLI_P01
Status last verified: Apr 2012
First submitted: 24 Apr 2012
Last updated: 25 Apr 2012
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
miRNAs in Critical Limb Ischemia (miRNACLI)
Critical Limb Ischemia
Active, not recruitingObservational study
Laser Atherectomy and Sirolimus-eluting Balloon Angioplasty for CLTI
Chronic Limb Threatening Ischemia
Recruiting
Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease
Peripheral Artery Disease, Diabetes Mellitus
RecruitingObservational study
Vessel Recoil in Specific CLTI Populations
Chronic Limb Threatening Ischemia
Not yet recruiting
DCB Outcomes After Non-Compliant Balloon Vessel Preparation With or Without Scoring in Patients With Femoropopliteal Arterial Disease
Femoropopliteal Disease, Drug Coated Balloon

All Critical Limb Ischemia trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Autologous Stem Cell Therapy for the Treatment of Patients With Peripheral Artery Disease
ClinicalTrials.gov ID: NCT01584986
Acronym / sponsor ID: ACP_CLI_P01
Conditions: Critical Limb Ischemia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: Salus Ltd.Industry (pharma, biotech, devices)
Collaborators: TheraVitae Ltd.
Study start: May 2008
Primary completion: Apr 2009 (actual)
Study completion: Jul 2009 (actual)
First posted: 25 Apr 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
ACP treated	Active comparator	Biological: ACP injectionsAutologous angiogenic cell precursors (ACPs) were injected into the ischemic gastrocnemius muscle in addition to the conventional treatment.
Control	No intervention	–Control patients were treated with the conventional therapy.

Who may qualify

Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (6 listed)

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;

Key exclusion criteria (20 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ACP injectionsPeripheral blood-derived, ex vivo expanded autologous angiogenic cell precursors (ACPs)	Biological	ACP treated

Primary outcome

Safety
Time frame: 3 months
Evaluation the safety of ACPs intramuscular injection
Rest pain
Time frame: 3 months
Pain-free walking distance
Time frame: 3 months
Ulcer size
Time frame: 3 months
Gangrene dimension and intensity
Time frame: 3 months
Obtain evidence for improvement of tissue perfusion due to ACPs injection
Time frame: 3 months

2 secondary outcomes

Reduction of CLI patients hospitalization time
Time frame: 3 months
Decrease CLI patient amputation rate
Time frame: 3 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2012.

Related trials for Critical Limb Ischemia

RecruitingObservational study
miRNAs in Critical Limb Ischemia (miRNACLI)
Critical Limb Ischemia
Active, not recruitingObservational study
Laser Atherectomy and Sirolimus-eluting Balloon Angioplasty for CLTI
Chronic Limb Threatening Ischemia
Recruiting
Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease
Peripheral Artery Disease, Diabetes Mellitus
RecruitingObservational study
Vessel Recoil in Specific CLTI Populations
Chronic Limb Threatening Ischemia
Not yet recruiting
DCB Outcomes After Non-Compliant Balloon Vessel Preparation With or Without Scoring in Patients With Femoropopliteal Arterial Disease
Femoropopliteal Disease, Drug Coated Balloon

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

György Acsády, DSc principal investigator

Semmelweis University Department of Cardiovascular Surgery

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ACP injections in people with Critical Limb Ischemia, run by Salus Ltd. at 2 sites in Hungary.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety (time frame: 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01584986.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2012.