Treatment of Severe Limb Ischemia With Autologous Bonemarrow Derived Mononuclear Cells (DANCELL-CLI)

Odense University Hospital

Status and phase: Unknown; Phase 1

Conditions: Ischemia

Treatments: Procedure: Stem cell implantation

Study type: Interventional

Funder types: Other

Identifiers

NCT00442143

024

Details and patient eligibility

About

The aim of the study is to investigate whether implantation of autologous bone marrow derived stem cells in ishemics limbs will improve vascularization

Full description

10 patients with severe lower limb ischemia will be included in this pilote trial.

Bonemarrow aspiration will be performed and and the monocuclear cells isolated an injected into the gastrocnemius.

The patiens are followed for 4 months. Were trancutaneous oxygenpressure, ankel and toe blood pressure is measured.

Enrollment: 10 estimated patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ankle blood pressure < 70 mmgHG
• Either pain at rest and/or ischemic wound
• No possible surgical treatment

Exclusion criteria

• Infection
• Malignant disease

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)