NCT00616980

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of intramuscular injections of adult stem cells in patients with Critical Limb Ischemia (CLI).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2007

Typical duration for phase_1

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2008

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 15, 2008

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

July 25, 2011

Status Verified

July 1, 2011

Enrollment Period

2.3 years

First QC Date

January 24, 2008

Last Update Submit

July 21, 2011

Conditions

Peripheral Artery DiseasePeripheral Vascular DiseaseCritical Limb Ischemia

Keywords

PADPVDCLIStem Cells

Outcome Measures

Primary Outcomes (5)

  • Safety of Intramuscular Injection of CD34-positive cells

    6 months and 1 year

  • Change in Rest Pain

    6 months

  • Ulcer Healing

    6 months

  • Functional Improvement

    6 months

  • Limb Salvage

    6 months

Secondary Outcomes (2)

  • Disease Severity

    6 months

  • Assessment of Co-morbidity

    6 months

Study Arms (3)

Low Dose

ACTIVE COMPARATOR
Biological: CD34-positive cells

High Dose

ACTIVE COMPARATOR
Biological: CD34-positive cells

Saline

PLACEBO COMPARATOR
Biological: Saline and 5% autologous plasma

Interventions

CD34-positive cellsBIOLOGICAL
Low Dose
Saline and 5% autologous plasmaBIOLOGICAL
Saline

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age
  • moderate or high-risk Critical Limb Ischemia (Rutherford Clinical Severity Score 4 or 5)
  • unsuitable for conventional revascularization

You may not qualify if:

  • advanced CLI (Rutherford Clinical Severity Score 6) characterized by extensive tissue loss or gangrene
  • advance AV block or NYHA Class III or Class IV heart failure
  • myocardial infarction within 3 months of treatment
  • successful coronary or lower extremity revascularization within 3 months of study enrollment
  • arterial insufficiency in the lower extremity is the result of a non-atherosclerotic disorder with the exception of thromboangitis obliterans (Buerger's Disease)
  • co-morbidity associated with life expectancy of less than 1 year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Cardiology, PC

Birmingham, Alabama, 35211, United States

Location

Florida Research Network LLC

Gainsville, Florida, 32605, United States

Location

Orlando Regional Medical Center

Orlando, Florida, 32806, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Mount Sinai School of Medicine Division of Vascular Surgery

New York, New York, 10029, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

University Hospitals of Cleveland, Case Medical Center

Cleveland, Ohio, 44106, United States

Location

University of Utah-Vascular Surgery Division

Salt Lake City, Utah, 84132, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

Comprehensive Cardiovascular Care St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

Related Publications (2)

  • Moazzami B, Mohammadpour Z, Zabala ZE, Farokhi E, Roohi A, Dolmatova E, Moazzami K. Local intramuscular transplantation of autologous bone marrow mononuclear cells for critical lower limb ischaemia. Cochrane Database Syst Rev. 2022 Jul 8;7(7):CD008347. doi: 10.1002/14651858.CD008347.pub4.

    PMID: 35802393DERIVED

  • Losordo DW, Kibbe MR, Mendelsohn F, Marston W, Driver VR, Sharafuddin M, Teodorescu V, Wiechmann BN, Thompson C, Kraiss L, Carman T, Dohad S, Huang P, Junge CE, Story K, Weistroffer T, Thorne TM, Millay M, Runyon JP, Schainfeld R; Autologous CD34+ Cell Therapy for Critical Limb Ischemia Investigators. A randomized, controlled pilot study of autologous CD34+ cell therapy for critical limb ischemia. Circ Cardiovasc Interv. 2012 Dec;5(6):821-30. doi: 10.1161/CIRCINTERVENTIONS.112.968321. Epub 2012 Nov 27.

    PMID: 23192920DERIVED

MeSH Terms

Conditions

Peripheral Arterial DiseasePeripheral Vascular DiseasesChronic Limb-Threatening Ischemia

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsIschemia

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDIV

Study Record Dates

First Submitted

January 24, 2008

First Posted

February 15, 2008

Study Start

December 1, 2007

Primary Completion

April 1, 2010

Study Completion

August 1, 2010

Last Updated

July 25, 2011

Record last verified: 2011-07

Locations

US(12)