- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05915962
Biological Characterization Study of an Autograft Nanofat (Nanocarabio) (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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Champigny-sur-Marne, France, 94500
- Hopital Prive Paul d'Egine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: volunteer for an autograft
Collecting and preparing a Nanofat-type autograft using a special kit.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Appearance of nanofat autografts
Time Frame: one month
|
Expected specification: colorless to slightly yellow
|
one month
|
Flow cytometry count of the following cells : leukocytes, stromal celles and endothelial cells
Time Frame: one month
|
|
one month
|
Functionality of nanofat autografts
Time Frame: one month
|
Expected specification: CFU-F > 10 per 1000 nucleated cells
|
one month
|
Microbiological sterility of nanofat autografts
Time Frame: one month
|
expected specification: negative
|
one month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2020-A01605-34
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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