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Open Label Single Arm Proof of Concept Trial to Evaluate the Efficacy and Safety of Cytori Celution System in Chronic Non-Healing Venous Leg Ulcers

NCT05165459 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-05-03

No results posted yet for this study

Summary

To evaluate the efficacy and safety of Cytori Celution System in Hungarian patients with chronic non-healing venous leg ulcers.

Conditions

  • Venous Leg Ulcer
  • Autologous Adipose Stromal Vascular Fraction
  • Adipose-Derived Mesenchymal Stem Cells
  • Mesenchymal Stem Cells

Interventions

DEVICE

Venous leg ulcer treatment with adipous SVF

The Celution® System isolates approximately maximum 30 million SVF cells per 100 mL of adipose tissue to be processed. Approximately 1-3 million cells per injection (total 8-30) will be administered locally, in the target ulcer.

Sponsors & Collaborators

  • Szeged University

    lead OTHER

Principal Investigators

  • Balázs Bende, MD · Szeged University

  • Lajos Kemény, Prof. Dr. · Szeged University

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-29
Primary Completion
2022-06-30
Completion
2022-06-30

Countries

  • Hungary

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05165459 on ClinicalTrials.gov