ACPs in Severe PAD/CLI by Direct Intramuscular Injection
Condition: Peripheral Arterial Disease; Critical Limb Ischemia
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases; Chronic Limb-Threatening Ischemia; Ischemia
Study type: Interventional
Phase: Phase 1

Summary: 
      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 Safety
      follow-up (D1&D2),Chronic follow-up (D30 & D90)period ,total follow-up of each case is 3
      months.

      Evaluation criteria :

      Safety : no.& duration of adverse event & serious adverse event Efficacy :Attenuate CLI
      patients symptoms (Rest pain,Pain-free walking distance,Ulcer size &Gangrene dimension and
      intensity)
    

Detailed description: 
      Six patients with Critical Limb Ischemia (CLI) or severe Peripheral Arterial Disease(PAD)
      will be enrolled, screened, treated with an injection of Blood-Borne Autologous Angiogenic
      Cell Precursors(ACPs) in to gastrocnemius of the ischemic leg by intramuscular under regional
      anesthesia. Following injection.
    

Intervention name(s): Angiogenic Cell Precursors (ACPs) or Vescell TM
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stem cells; Rest pain; claudication; chronic ischemic or non-healing ulcers; Angiogenesis; no-option cases