Biological Characterization Study of an Autograft Nanofat (Nanocarabio)

Study Overview
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Brief Summary
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Rhizarthrosis (trapeziometacarpal osteoarthritis) is the most common primary osteoarthritis of the hand, and a source of major functional impact, as it affects the thumb. Non-surgical therapeutic means are currently limited to wearing an immobilization splint, analgesics and oral non-steroidal anti-inflammatory drugs. These symptomatic treatments are of limited effectiveness and do not prevent from progression of the osteoarthritis disease. The most effective treatments currently recognized are surgical, but they also have their limits. Cell therapy is considered as a promising approach to treat tissue damage including osteoarthritis. Mesenchymal stromal cells are excellent candidates for achieving this type of result, because they can differentiate into the different tissues from the mesoderm (cartilage, bone, muscle, tendons, fat, dermis, conjunctive matrix, etc.). In addition, unlike cells from the embryonic cord, the risk of teratoma or tumor does not exist. Mesenchymal stem cells have regenerative and immunomodulatory properties but the methods of collection, preparation, combination with substances such as hyaluronic acid, or PRP, or platelet concentrates, will obviously influence the effectiveness of the results. . Nanofat autografts are obtained in a simple way, in a closed circuit, preserving the stromal mesenchymal cells in large numbers with a minimum impact on the cellular elements. The preparation remains simple and inexpensive, but it is nevertheless necessary to characterize these emulsified preparations biologically before using them as cell therapy. The main objective of this study is to characterize a nanofat autograft on a biological level.

Official Title
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Biological Characterization Study of an Autograft Nanofat (Nanocarabio)

Conditions
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Rhizarthrosis

Intervention / Treatment
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* Procedure: collecting a Nanofat-type microfat autograft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Volunteers, men or women, aged at least 20 to 75 years old. BMI ≥ 20 Kg/m² (in order to have adipose tissue in quantity sufficient) Volunteers who signed an informed consent Hemoglobinemia > 10g/dl Negative Beta-HCG assay Volunteers benefiting from or affiliated to a social security scheme Exclusion Criteria: Thrombocytopenia < 150 G/L Thrombocytosis > 450 G/L Known thrombopathy TP < 70% APT Patient/Control ratio > 1.20 Anemia < 10g/dl Taking antiplatelet, aspirin, anti vitamin K dating less than 15 days before inclusion Fever or recent infection (bacterial or viral) dating from less than a month Autoimmune diseases confirmed by questioning, or clinical and/or biological elements (inflammatory assessment: VS, CRP, fibrinogen) and may interfere with the quality of autograft Inflammatory arthritis Microcrystalline Arthritis Immunodeficiency Current or chronic infectious diseases (viral or bacterial) attested by clinical elements and/or biological (inflammatory assessment: ESR, CRP, Fibrinogen) Malignant tumor under treatment or history of malignant tumor BMI < 20 Kg/m² Contraindication to local anesthesia or surgery Pregnant or breastfeeding women Adults protected by law (under guardianship and guardianship) People participating simultaneously in another research involving the human person Miners Persons staying in a health or social establishment People in an emergency situation Persons deprived of liberty Persons not covered by a social security scheme

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: volunteer for an autograft<br>Collecting and preparing a Nanofat-type autograft using a special kit. | Procedure: collecting a Nanofat-type microfat autograft<br>* Collecting and preparing a Nanofat autograft. The protocol provides for the fat sample to be taken in a doctor's office during a consultation. The preparation will then be carried out at the MEARY center for cell and gene therapy of the AP-HP, at the Saint Louis hospital in Paris.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appearance of nanofat autografts | Expected specification: colorless to slightly yellow | one month | 
| Flow cytometry count of the following cells : leukocytes, stromal celles and endothelial cells | Leukocytes (CD45+): 15 to 55% Stromal cells (CD45-CD34bright CD146-CD90+): 40 to 60% Endothelial cells (CD34bright CD146+CD45-): 1 to 19% | one month | 
| Functionality of nanofat autografts | Expected specification: CFU-F > 10 per 1000 nucleated cells | one month | 
| Microbiological sterility of nanofat autografts | expected specification: negative | one month |