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Trial record 14 of 72 for:    stem cell peripheral arterial disease AND cell therapy

Intra-arterial Stem Cell Therapy for Patients With Chronic Limb Ischemia (CLI) (JUVENTAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00371371
Recruitment Status : Completed
First Posted : September 4, 2006
Last Update Posted : December 13, 2012
Sponsor:
Collaborator:
Catharijne Foundation
Information provided by (Responsible Party):
R.W. Sprengers, MD, PhD, UMC Utrecht

Tracking Information
First Submitted Date  ICMJE September 1, 2006
First Posted Date  ICMJE September 4, 2006
Last Update Posted Date December 13, 2012
Study Start Date  ICMJE September 2006
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2008)
major amputation [ Time Frame: six months ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 1, 2006)
amputation within inclusion period
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2008)
  • minor amputation [ Time Frame: six months ]
  • number and extent of leg ulcers [ Time Frame: six months ]
  • resolvement of rest pain [ Time Frame: six months ]
  • improvement of ankle-brachial index (ABI) [ Time Frame: six months ]
  • improvement transcutaneous oxygen pressure (TcpO2) [ Time Frame: six months ]
  • changes in quality of life [ Time Frame: suix months ]
  • changes in clinical status (Rutherford classification) [ Time Frame: six months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 1, 2006)
  • CLI related hospitalisation
  • walking test
  • ankle-brachial pressure index
  • transcutaneous oxygen pressure
  • vasculogenesis assessed with MRA
  • pain score
  • quality of life
Current Other Pre-specified Outcome Measures
 (submitted: December 12, 2012)
  • Amputation-free survival [ Time Frame: six months ]
  • Treatment failure [ Time Frame: six months ]
    Composite endpoint defined as major amputation of treated leg, all-cause mortality, doubling in total wound surface area, or de novo gangrene
  • Successfull treatment [ Time Frame: six months ]
    Composite endpoint defined as subject is (A) alive, (B) without major amputation of index limb, (C) not worsened rutherford class or VAS, and (D) improved in either Rutherford or VAS (>30mm)
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intra-arterial Stem Cell Therapy for Patients With Chronic Limb Ischemia (CLI)
Official Title  ICMJE Intra-arterial Infusion of Autologous Bone Marrow Mononuclear Cells in Patients With Chronic Critical Limb Ischemia: a Randomized, Placebo-controlled Clinical Trial
Brief Summary The purposes of this study are to determine whether intra-arterial injection of autologous stem cells is effective in the treatment of chronic limb ischemia (CLI), to characterize stem cell dysfunction in patients with CLI, and to relate the stem cell function with clinical outcome.
Detailed Description

Despite advances in surgical and radiological vascular techniques, a significant number of patients with chronic critical limb ischaemia (CLI) are not eligible for revascularization procedures, often leaving amputation as the only option. Consequently, exploring new strategies for revascularization of ischemic limbs is of major importance. Preclinical studies and pioneering clinical trials suggest that administration of bone marrow (BM) mononuclear cells (MNC) into ischemic limbs enhances neovascularization, improves tissue perfusion and prevents amputation. However, no definite proof is available as the clinical studies thus far have been small and lacked double-blinded controls.

JUVENTAS is a randomized, double-blinded placebo-controlled trial in 109 - 160 patients with CLI to investigate the potential clinical effects of repeated intra-arterial infusion of BM-MNC in these patients (the exact number of patients to be included cannot be specified in advance because of the planned group sequential interim analyses). In addition, it will study the functional characteristics of the BM-MNC obtained from CLI patients and relate BM-MNC dysfunction to clinical outcome.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Peripheral Vascular Diseases
  • Arterial Occlusive Diseases
  • Leg Ulcer
  • Gangrene
  • Ischemia
Intervention  ICMJE
  • Procedure: Bone marrow punction
    A total volume of 100 ml bone marrow will be aspirated from the iliac crest under local anaesthesia (lidocaine) according to local routine. To maximise the patients comfort, 5-10 mg midazolam and 50 ug fentanyl will be administered intravenously.
  • Procedure: BM-MNC infusion
    Repeated intra-arterial infusion of autologous BM-MNC into the common femoral artery
  • Procedure: Placebo infusion
    Repeated intra-arterial infusion of placebo (PBS/4% HAS/heparin, coloured with autologous erythrocytes to match the colour of BM-MNC suspension) into the common femoral artery.
Study Arms  ICMJE
  • Experimental: BM-MNC
    autologous bone marrow-derived mononuclear cells
    Interventions:
    • Procedure: Bone marrow punction
    • Procedure: BM-MNC infusion
  • Placebo Comparator: Placebo
    Placebo
    Interventions:
    • Procedure: Bone marrow punction
    • Procedure: Placebo infusion
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 5, 2011)
160
Original Enrollment  ICMJE
 (submitted: September 1, 2006)
110
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age > 18 years
  • Severe infra-popliteal peripheral arterial occlusive disease [PAOD] (Fontaine class IIb, III or IV)
  • Invalidating intermittent claudication, persistent, recurring rest pain requiring analgesia and/or non-healing ulcers present for > 4 weeks without evidence of improvement in response to conventional therapies
  • Ankle brachial index < 0.6 or "unreliable"
  • Not eligible for surgical or radiological revascularization
  • Written informed consent

Exclusion Criteria:

  • History of neoplasm or malignancy in the past 10 years
  • Serious known concomitant disease with life expectancy of less than one year
  • Anticipated inability to obtain 100 ml of bone marrow aspirate
  • Known infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus
  • Follow-up impossible
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00371371
Other Study ID Numbers  ICMJE JUVENTAS
06/030 ( Other Grant/Funding Number: Catharijne Foundation )
CS 06.007
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party R.W. Sprengers, MD, PhD, UMC Utrecht
Study Sponsor  ICMJE UMC Utrecht
Collaborators  ICMJE Catharijne Foundation
Investigators  ICMJE
Study Chair: Frans L Moll, MD, PhD UMC Utrecht
Study Director: Marianne C Verhaar, MD, PhD UMC Utrecht
Principal Investigator: Ralf W Sprengers, MD, PhD UMC Utrecht
Principal Investigator: Martin Teraa, MD UMC Utrecht
PRS Account UMC Utrecht
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP