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Completed

NCT Number: NCT05915962

Biological Characterization Study of an Autograft Nanofat (Nanocarabio)

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.

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Key information

Conditions

Rhizarthrosis

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Privé Paul d'Egine

Champigny-sur-Marne, 94500, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Appearance of nanofat autografts

    Time frame: one month

    Expected specification: colorless to slightly yellow

  2. Flow cytometry count of the following cells : leukocytes, stromal celles and endothelial cells

    Time frame: one month

    • Leukocytes (CD45+): 15 to 55%
    • Stromal cells (CD45-CD34bright CD146-CD90+): 40 to 60%
    • Endothelial cells (CD34bright CD146+CD45-): 1 to 19%

  3. Functionality of nanofat autografts

    Time frame: one month

    Expected specification: CFU-F > 10 per 1000 nucleated cells

  4. Microbiological sterility of nanofat autografts

    Time frame: one month

    expected specification: negative

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Registry information

Acronym: Nanocarabio

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 23, 2023
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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