ACPs in Severe PAD/CLI by Direct Intramuscular Injection
CompletedPhase 1NCT00523731
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Study title: A Study of Blood-Borne Autologous Angiogenic Cell Precursors Therapy in Patients with Critical Limb Ischemia ( ACPs-CLI ) Principle Investigator: Assoc.Prof. Pramook Mutirangura,M.D. Head of Division of Vascular Surgery , Department of Surgery, Faculty of Medicine Siriraj Hospital , Mahidol University, BKK,Thailand Study objective : To determine the safety and efficacy of intramuscular injection of blood-borne autologous ACPs in relieving symptoms of critical limb ischemia of patients treated with maximal medical therapy and don't have intravascular or operative revascularization option. Study Design : A pilot study , a single center, a non-randomized, open-label trial. Total expected no. of patients : 6 main selection criteria : A. Subjects will have 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 B. Subjects will have one or more of the following hemodynamic indicators of severe peripheral arterial occlusive disease: I. Ankle brachial index \< 0.45 II. Toe brachial index \< 0.35 III. TcPO2 / TcO2 of \< 40 mmHg. C. The subject is a poor candidate for standard revascularization treatment for peripheral arterial disease, based on inadequate bypass conduit, or unfavorable anatomy D. Age 18 to 80 years Investigational Product : At D-8 250 ml of blood drawn from the patients for production of autologous EPCs or ACPs (VescellTM). On D0 ,at least 1.5 million ACPs with viability \>75 % suspended in 30 ml sterile cell culture medium will be injected 1.5 cm deep and 1.5 apart by a 23 -gauge needle into the gastrocnemius muscle of the leg chosen (ischemic leg) for treatment. For injection planning a grid of 10X10 cm will be prepared and in each point 1 ml of ACPs suspension will be injected. The study consists of 4 periods: Screening ( D-14 to-9\& D-8,Treatment(D0),Acute Saf…
Study details
- Official title
- A Study of Blood-Borne Autologous Angiogenic Cells Precursors Therapy in Patients With Critical Limb Ischemia
- Interventions
- Procedure: Angiogenic Cell Precursors (ACPs) or Vescell TM
- Sponsor
- TheraVitae Ltd.
- Start date
- 2006-01
- Sex
- All
- Age range
- from 18 Years to 80 Years
- Results posted
- No results posted in this snapshot
- Countries
- Israel
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Subjects will have 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 will have one or more of the following hemodynamic indicators of severe peripheral arterial occlusive disease: * Ankle brachial index \< 0.45 * Toe brachial index \< 0.35 * TcPO2 / TcO2 of \< 40 mmHg. * The subject is 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 during the preceding 3 months * After heart transplantation * Severe cardiomyopathy (EF \< 25 %) * Renal failure (creatinine \> 2 mg/dl ) * Hepatic failure * Anemia (lower than 11mg/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 ; HBA1c \>8 % and proliferative retinopathy , systemic lupus erythematosus, multiple sclerosis, amyotrophic lateral sclerosis) * Chronic immunomodulating or cytotoxic drugs treatment * Patients who have rectal temp. above 38.40C for 2 consecutive days * Patient unlikely to be available for follow-up
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00523731