Trials / Unknown
UnknownNCT05165459
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
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- Sponsor
- Szeged University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the efficacy and safety of Cytori Celution System in Hungarian patients with chronic non-healing venous leg ulcers.
Detailed description
This motive trial can help to establish routine application of this internationally widely used device at University of Szeged. The primary outcome is the reduction rate of the wound size. The treatment response will be calculated from wound size before and after treatment. Any adverse events related to the study device will be monitored.
Conditions
- Venous Leg Ulcer
- Autologous Adipose Stromal Vascular Fraction
- Adipose-Derived Mesenchymal Stem Cells
- Mesenchymal Stem Cells
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2021-11-29
- Primary completion
- 2022-06-30
- Completion
- 2022-06-30
- First posted
- 2021-12-21
- Last updated
- 2022-05-03
Locations
1 site across 1 country: Hungary
Source: ClinicalTrials.gov record NCT05165459. Inclusion in this directory is not an endorsement.