Biological Characterization Study of an Autograft Nanofat (Nanocarabio)

Plain-language summary

This study examined the biological properties of a Nanofat-type microfat graft (autograft) prepared from a person's own fat tissue. It enrolled healthy volunteers aged 20 to 75 who had sufficient fat tissue. It was a study without an assigned phase and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Completed

Sponsor

Ramsay Générale de Santé

Intervention

collecting a Nanofat-type microfat autograft

Start date

6/3/2022

Estimated completion

9/9/2022

Countries

France

Related genes

Locations

• Champigny-sur-Marne, France

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

1. Volunteers, men or women, aged at least 20 to 75 years old.
2. BMI ≥ 20 Kg/m² (in order to have adipose tissue in quantity sufficient)
3. Volunteers who signed an informed consent
4. Hemoglobinemia \> 10g/dl
5. Negative Beta-HCG assay
6. Volunteers benefiting from or affiliated to a social security scheme

Exclusion Criteria:

1. Thrombocytopenia \< 150 G/L
2. Thrombocytosis \> 450 G/L
3. Known thrombopathy
4. TP \< 70%
5. APT Patient/Control ratio \> 1.20
6. Anemia \< 10g/dl
7. Taking antiplatelet, aspirin, anti vitamin K dating less than 15 days before inclusion
8. Fever or recent infection (bacterial or viral) dating from less than a month
9. Autoimmune diseases confirmed by questioning, or clinical and/or biological elements (inflammatory assessment: VS, CRP, fibrinogen) and may interfere with the quality of autograft
10. Inflammatory arthritis
11. Microcrystalline Arthritis
12. Immunodeficiency
13. Current or chronic infectious diseases (viral or bacterial) attested by clinical elements and/or biological (inflammatory assessment: ESR, CRP, Fibrinogen)
14. Malignant tumor under treatment or history of malignant tumor
15. BMI \< 20 Kg/m²
16. Contraindication to local anesthesia or surgery
17. Pregnant or breastfeeding women
18. Adults protected by law (under guardianship and guardianship)
19. People participating simultaneously in another research involving the human person
20. Miners
21. Persons staying in a health or social establishment
22. People in an emergency situation
23. Persons deprived of liberty
24. Persons not covered by a social security scheme