Biological Characterization Study of an Autograft Nanofat (Nanocarabio)

NCT05915962 | Completed

• 1 other identifier: 2020-A01605-34
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rhizarthrosis

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

volunteer for an autograft

EXPERIMENTAL

Collecting and preparing a Nanofat-type autograft using a special kit.

Procedure: collecting a Nanofat-type microfat autograft

Interventions

collecting a Nanofat-type microfat autograft PROCEDURE

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.

volunteer for an autograft

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Thrombocytopenia \< 150 G/L
• Thrombocytosis \> 450 G/L
• Known thrombopathy
• TP \< 70%
• APT Patient/Control ratio \> 1.20
• Anemia \< 10g/dl
• 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

Sponsors & Collaborators

• Ramsay Générale de Santé: lead

Study Sites (1)

Hôpital Privé Paul d'Egine

Champigny-sur-Marne, 94500, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: June 23, 2023
• Study Start: June 3, 2022
• Primary Completion: July 9, 2022
• Study Completion: September 9, 2022
• Last Updated: June 23, 2023

Record last verified: 2023-06

Locations

FR (1)