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Clinical Trials/ISRCTN16096154
ISRCTN16096154
Completed
Not Applicable

Transplantation of autologous bone marrow cells in patients with no-option critical limb ischemia

ational Institute of Heart and Vascular Diseases0 sites62 target enrollmentJuly 26, 2016
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
ational Institute of Heart and Vascular Diseases
Enrollment
62
Status
Completed
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 26, 2016
End Date
TBD
Last Updated
8 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
ational Institute of Heart and Vascular Diseases

Eligibility Criteria

Inclusion Criteria

  • •1\. Patients over 18 years of age
  • •2\. With ischemic skin lesions (ulcers or gangrene) with a Critical limb ischemia Rutherford category of 5 or 6 according to the TransAtlantic InterSociety Consensus (TASC) classification (minor or major tissue loss)
  • •3\. Critical limb ischemia defined by ankle–brachial index \=0\.4, or ankle systolic pressure \<50 mmHg, or toe systolic pressure \<30 mmHg, or transcutaneous oxygen pressure (tcpO2\) \<30 mmHg
  • •4\. No option for endovascular or surgical revascularization assessed by a vascular surgeon and interventionalist
  • •5\. Failed revascularization defined as no change of clinical status with the best standard care 4 weeks after endovascular or surgical revascularization

Exclusion Criteria

  • •1\. Life expectancy \<6 months
  • •2\. Evidence of malignancy during last 5 years
  • •3\. Proliferative retinopathy
  • •4\. Critical coronary artery disease or unstable angina pectoris
  • •5\. End\-stage kidney disease and patient on dialysis
  • •6\. Bone\-marrow disease (e.g., myelodysplastic syndrome, severe anemia, leukopenia, thrombocytopenia)

Outcomes

Primary Outcomes

Not specified

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