NCT00282646

Brief Summary

Patients with peripheral artery disease, stage III or IV who are not candidates for interventional or operative therapy should be treated with intraarterial progenitor cell therapy (autologous bone marrow cells) in a randomized, placebo controlled trial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2005

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

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

October 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 27, 2006

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

October 26, 2021

Status Verified

October 1, 2021

Enrollment Period

5 years

First QC Date

January 25, 2006

Last Update Submit

October 18, 2021

Conditions

Arterial Occlusive Diseases

Keywords

critical limb ischemiaperipheral arterial occlusive disease[C14.907.137]

Outcome Measures

Primary Outcomes (1)

  • Ankle brachial index

    6 months

Secondary Outcomes (4)

  • Ulcer size

    6 months

  • Pain

    6 months

  • Walking distance

    6 months

  • TCO2

    6 months

Study Arms (2)

1

ACTIVE COMPARATOR

intraarterial application of bone marrow mononuclear cells

Procedure: intraarterial stem cell therapyOther: Stem cells

2

PLACEBO COMPARATOR

intraarterial application of placebo

Procedure: intraarterial stem cell therapyOther: Stem cells

Interventions

intraarterial stem cell therapyPROCEDURE

catheter delivery of stem cells

12
Stem cellsOTHER

intraarterial application of bone marrow mononuclear cells versus placebo

12

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with PAOD (Stage III or IV)
  • Distal arterial occlusions
  • Patients with Buergers Disease
  • Signed informed consent

You may not qualify if:

  • Successful bypass operation or intervention within the last 3 months
  • Active infection, feber, chronic inflammatory disease
  • HIV, Hepatitis
  • Tumor within the last 5 years, complete remission required
  • Stroke or myocardial infarction within last 3 months
  • Renal insufficiency (creatinine \> 2 mg/dl)
  • Liver disease (GOT \> 2x upper limit oder spontaneous INR \> 1,5).
  • Anemia (hemoglobin \< \<10 mg/dl)
  • Thrombocytopenia \< 100.000/µl
  • Allergies to Aspirin, Clopidogrel, Heparin
  • Bleeding disorder
  • Gastrointestinal bleeding within last 3 months
  • Surgery or trauma within the last 2 months
  • Pregnancy
  • Mental retardation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Div. of Cardiology and Vascular Medicine

Frankfurt, 60590, Germany

Location

Related Publications (2)

  • Sciahbasi A, Romagnoli E, Trani C, Burzotta F, Sarandrea A, Summaria F, Patrizi R, Rao S, Lioy E. Operator radiation exposure during percutaneous coronary procedures through the left or right radial approach: the TALENT dosimetric substudy. Circ Cardiovasc Interv. 2011 Jun;4(3):226-31. doi: 10.1161/CIRCINTERVENTIONS.111.961185. Epub 2011 May 17.

    PMID: 21586692DERIVED

  • Walter DH, Krankenberg H, Balzer JO, Kalka C, Baumgartner I, Schluter M, Tonn T, Seeger F, Dimmeler S, Lindhoff-Last E, Zeiher AM; PROVASA Investigators. Intraarterial administration of bone marrow mononuclear cells in patients with critical limb ischemia: a randomized-start, placebo-controlled pilot trial (PROVASA). Circ Cardiovasc Interv. 2011 Feb 1;4(1):26-37. doi: 10.1161/CIRCINTERVENTIONS.110.958348. Epub 2011 Jan 4.

    PMID: 21205939DERIVED

MeSH Terms

Conditions

Arterial Occlusive DiseasesChronic Limb-Threatening IschemiaPeripheral Arterial Occlusive Disease 1

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPeripheral Arterial DiseaseAtherosclerosisArteriosclerosisPeripheral Vascular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsIschemia

Study Officials

  • Andreas M Zeiher, MD

    Div. of Cardiology, University of Frankfurt, Germany

    PRINCIPAL INVESTIGATOR

  • Dirk H Walter, MD

    Div. of Cardiology, University of Frankfurt, Germany

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Intraarterial administration of BM-MNC or placebo
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. A.M. Zeiher

Study Record Dates

First Submitted

January 25, 2006

First Posted

January 27, 2006

Study Start

October 1, 2005

Primary Completion

October 1, 2010

Study Completion

March 1, 2011

Last Updated

October 26, 2021

Record last verified: 2021-10

Locations

DE(1)