Biological Characterization Study of an Autograft Nanofat (Nanocarabio)

Rhizarthrosis Clinical Trial

— Nanocarabio  

Official title:

Biological Characterization Study of an Autograft Nanofat (Nanocarabio)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05915962
• Other study ID #: 2020-A01605-34
• Status: Completed
• Phase: N/A
• Start date: June 3, 2022
• Est. completion date: September 9, 2022

Study information

• Verified date: June 2023
• Source: Ramsay Générale de Santé
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 9, 2022
• Est. primary completion date: July 9, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 75 Years

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

Related Conditions & MeSH terms

• Rhizarthrosis

Intervention

Procedure:
• collecting a Nanofat-type microfat autograft
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.

Locations

Country	Name	City	State
France	Hôpital Privé Paul d'Egine	Champigny-sur-Marne

Sponsors (1)

Lead Sponsor	Collaborator
Ramsay Générale de Santé

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Appearance of nanofat autografts	Expected specification: colorless to slightly yellow	one month
Primary	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
Primary	Functionality of nanofat autografts	Expected specification: CFU-F > 10 per 1000 nucleated cells	one month
Primary	Microbiological sterility of nanofat autografts	expected specification: negative	one month