ACPs in Severe PAD/CLI by Direct Intramuscular Injection

Status Completed

Clinical Trial 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)

Clinical Trial 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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00523731
Study type	Interventional
Source	TheraVitae Ltd.
Contact
Status	Completed
Phase	Phase 1
Start date	January 2006
Completion date	March 2007

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06032065` - Sequential Multiple Assessment Randomized Trial of Exercise for PAD: SMART Exercise for PAD (SMART PAD)	Phase 3
Active, not recruiting	`NCT03987061` - MOTIV Bioresorbable Scaffold in BTK Artery Disease	N/A
Recruiting	`NCT03506633` - Impacts of Mitochondrial-targeted Antioxidant on Peripheral Artery Disease Patients	N/A
Active, not recruiting	`NCT03506646` - Dietary Nitrate Supplementation and Thermoregulation	N/A
Active, not recruiting	`NCT04677725` - NEtwork to Control ATherothrombosis (NEAT Registry)
Recruiting	`NCT05961943` - RESPONSE-2-PAD to Reduce Sedentary Time in Peripheral Arterial Disease Patients	N/A
Recruiting	`NCT06047002` - Personalised Antiplatelet Therapy for Patients With Symptomatic Peripheral Arterial Disease
Completed	`NCT03185052` - Feasibility of Outpatient Care After Manual Compression in Patients Treated for Peripheral Arterial Disease by Endovascular Technique With 5F Sheath Femoral Approach	N/A
Recruiting	`NCT05992896` - A Study of Loco-Regional Liposomal Bupivacaine Injection	Phase 4
Completed	`NCT04635501` - AbsorbaSeal (ABS 5.6.7) Vascular Closure Device Trial	N/A
Recruiting	`NCT04584632` - The Efemoral Vascular Scaffold System (EVSS) for the Treatment of Patients With Symptomatic Peripheral Vascular Disease From Stenosis or Occlusion of the Femoropopliteal Artery	N/A
Withdrawn	`NCT03994185` - The Merit WRAPSODY™ Endovascular Stent Graft for Treatment of Iliac Artery Occlusive Disease	N/A
Withdrawn	`NCT03538392` - Serranator® Alto Post Market Clinical Follow Up (PMCF) Study
Recruiting	`NCT02915796` - Autologous CD133(+) Cells as an Adjuvant to Below the Knee Percutaneous Transluminal Angioplasty	Phase 1
Active, not recruiting	`NCT02900924` - Observational Study to Evaluate the BioMimics 3D Stent System: MIMICS-3D
Completed	`NCT02901847` - To Evaluate the Introduction of a Public Health Approach to Peripheral Arterial Disease (PAD) Using National Centre for Sport and Exercise Medicine Facilities.	N/A
Withdrawn	`NCT02126540` - Trial of Pantheris System, an Atherectomy Device That Provides Imaging While Removing Plaque in Lower Extremity Arteries	N/A
Not yet recruiting	`NCT02387450` - Reduced Cardiovascular Morbi-mortality by Sildenafil in Patients With Arterial Claudication	Phase 2/Phase 3
Not yet recruiting	`NCT02455726` - Magnesium Oral Supplementation to Reduce Pain Inpatients With Severe Peripheral Arterial Occlusive Disease	N/A
Completed	`NCT02384980` - Saving Life and Limb: FES for the Elderly With PAD	Phase 1