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Trial record 3 of 70 for:    stem cell peripheral arterial disease AND cell therapy

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

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ClinicalTrials.gov Identifier: NCT01584986
Recruitment Status : Completed
First Posted : April 25, 2012
Last Update Posted : April 25, 2012
Sponsor:
Collaborator:
TheraVitae Ltd.
Information provided by (Responsible Party):
Salus Ltd.

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.

Condition or disease Intervention/treatment Phase
Critical Limb Ischemia Biological: ACP injections Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autologous Stem Cell Therapy for the Treatment of Patients With Peripheral Artery Disease
Study Start Date : May 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: ACP treated
Autologous angiogenic cell precursors (ACPs) were injected into the ischemic gastrocnemius muscle in addition to the conventional treatment.
Biological: ACP injections
Peripheral blood-derived, ex vivo expanded autologous angiogenic cell precursors (ACPs)

No Intervention: Control
Control patients were treated with the conventional therapy.



Primary Outcome Measures :
  1. Safety [ Time Frame: 3 months ]
    Evaluation the safety of ACPs intramuscular injection

  2. Rest pain [ Time Frame: 3 months ]
  3. Pain-free walking distance [ Time Frame: 3 months ]
  4. Ulcer size [ Time Frame: 3 months ]
  5. Gangrene dimension and intensity [ Time Frame: 3 months ]
  6. Obtain evidence for improvement of tissue perfusion due to ACPs injection [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Reduction of CLI patients hospitalization time [ Time Frame: 3 months ]
  2. Decrease CLI patient amputation rate [ Time Frame: 3 months ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01584986


Locations
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Hungary
Kelen Hospital
Budapest, Hungary
Semmelweis University Department of Cardiovascular Surgery
Budapest, Hungary
Sponsors and Collaborators
Salus Ltd.
TheraVitae Ltd.
Investigators
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Principal Investigator: György Acsády, DSc Semmelweis University Department of Cardiovascular Surgery

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Responsible Party: Salus Ltd.
ClinicalTrials.gov Identifier: NCT01584986     History of Changes
Other Study ID Numbers: ACP_CLI_P01
First Posted: April 25, 2012    Key Record Dates
Last Update Posted: April 25, 2012
Last Verified: April 2012
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Ischemia
Pathologic Processes
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases