A Multi-centre, double blind, randomized placebo controlled phase II study to assess the efficacy and safety of ASCT01 in Critical limb Ischemia Patients - SCILI - SCILI

• Conditions: Critical Limb Ischemia Rutherford clas 4-6

• Registration Number: EUCTR2010-024391-25-CZ
• Lead Sponsor: XCell-Center GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-31
• Last Update Posted: 29 May 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

1.Patients in the age group of 18-75 yrs.
2.Established CLI (confirmed by Rutherford 4 to 6 or Fontaine III-IV to the
recommendations of the TASC) with infra-inguinal arterial occlusive
disease
3.Ankle Brachial Pressure Index (ABPI) = 0.6 or the absolute ankle blood
pressure < 60 mm Hg or TcPO2 <20 mmHg without tissue loss or TcPO2
<40 mmHg if there is tissue loss.
4.No surgical or interventional option for revascularization and no response
to best standard care delivered as confirmed by a vascular surgeon.
5.No immediate life-threatening complication from CLI which would demand
immediate amputation.
6.Patients who are able to understand the requirements of the study, and
willing to provide voluntary written informed consent, abide by the study
requirements, and agree to return for required follow-up visits.
7.Coagulation status aPTT within normal limits
8.Sufficient number of stem cells isolated from bone marrow (> 2 million
CD34+).
9.Viability of isolated stem cells > 90%.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Acute life threatening complication of limb ischemia with the need for
immediate limb amputation to avoid death or clinical deterioration
2.Patients with documented terminal illness or cancer or any concomitant
disease process with a life expectancy of less than 6 months.
3.Patients with a history of severe alcohol or drug abuse within 3 months of
screening.
4.Known bone marrow diseases which preclude transplantation.
5.End-stage renal failure on regular dialysis treatment
6.Patients already enrolled in another investigational drug trial or completed
within 3 months.
7.Pregnancy.
8.Patients tested positive for HIV 1, HCV, and/or HBV

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified