Lipofilling with MSC enriched fat, a permanent autologous filler?

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-023006-12-DK

Enrollment

Registered

2010-11-09

Start date

2011-01-14

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients who have a need of reconstruction after surgery, eg. after mastectomy. The purpose of this clinical trial, is to make a reproducible and safe method for fat transplantation, that can be used for larger reconstructions. It is a healthy volunteer trial. MedDRA version: 12.1 Level: PT Classification code 10037773 Term: Radical mastectomy

Interventions

Product Name: Mesenchymal stem cells (MSC) Pharmaceutical Form: Concentrate for solution for injection Pharmaceutical form of the placebo: Concentrate for solution for

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy volunteers Men and Women Age: 18-45 BMI 20-30 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Known chronic disease, eg.: Angina pectoris, COLD, diabetes, reduced renal function, previous cancer or family disposition to cancer, metabolic disease, HIV, chronic hepatitis, etc. Previous abdominal surgery Pregnancy Active breast feeding Smoking.

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of this clinical trial, is to establish a reproducible and safe method for fat transplantation, that can be used for larger reconstructions. Fat grafts after transplantation will be examined, the residual volume will be evaluated by MR. MSC enriched fat vs. non-MSC enriched fat (control) will be testet. ;Secondary Objective: To evaluate the histology of the transplantet fat grafts and to register side effects of the treatment.; Primary end point(s): 1) To examine the residual volume of fat grafts after transplantation, evaluated by MR. MSC enriched fat vs. non-MSC enriched fat (control). 2) To examine the histology of the tranplantet fat grafts (MSC enriched fat vs. non-MSC enriched fat (control)): a) Capillary density b) Distribution of fat tissue, fat necrosis and fibrosis. 3) Registration of side effects.	—

Measure

Time frame

Main Objective: The objective of this clinical trial, is to establish a reproducible and safe method for fat transplantation, that can be used for larger reconstructions. Fat grafts after transplantation will be examined, the residual volume will be evaluated by MR. MSC enriched fat vs. non-MSC enriched fat (control) will be testet. ;Secondary Objective: To evaluate the histology of the transplantet fat grafts and to register side effects of the treatment.; Primary end point(s): 1) To examine the residual volume of fat grafts after transplantation, evaluated by MR. MSC enriched fat vs. non-MSC enriched fat (control). 2) To examine the histology of the tranplantet fat grafts (MSC enriched fat vs. non-MSC enriched fat (control)): a) Capillary density b) Distribution of fat tissue, fat necrosis and fibrosis. 3) Registration of side effects.

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Countries

Denmark

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026