RhizarthrosisNanocarabioNCT05915962
Biological Characterization Study of an Autograft Nanofat (Nanocarabio)
A study testing collecting a Nanofat-type microfat autograft in people with Rhizarthrosis, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Rhizarthrosis
- What is being tested?
- collecting a Nanofat-type microfat autograft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jun 2022to 9 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Thrombocytopenia < 150 G/L
- Thrombocytosis > 450 G/L
- Known thrombopathy
- TP < 70%
- APT Patient/Control ratio > 1.20
- Anemia < 10g/dl
Show all 24Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- collecting a Nanofat-type microfat autograft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collecting a Nanofat-type microfat autograftProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| volunteer for an autograft | Experimental | Collecting and preparing a Nanofat-type autograft using a special kit. Receives: Procedure: collecting a Nanofat-type microfat autograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appearance of nanofat autografts
Expected specification: colorless to slightly yellow
Measured: 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%
Measured: one month
Functionality of nanofat autografts
Expected specification: CFU-F > 10 per 1000 nucleated cells
Measured: one month
Microbiological sterility of nanofat autografts
expected specification: negative
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start3 Jun 2022
- Primary completion9 Jul 2022
- Study completion9 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhizarthrosisStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05915962
- Sponsor's protocol ID
- 2020-A01605-34
- Acronym
- Nanocarabio
- Status last verified
- Jul 2026
- First submitted
- 12 Jun 2023
- Last updated
- 16 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological Characterization Study of an Autograft Nanofat (Nanocarabio)
- ClinicalTrials.gov ID
- NCT05915962
- Acronym / sponsor ID
- Nanocarabio / 2020-A01605-34
- Conditions
- Rhizarthrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 3 Jun 2022 (actual)
- Primary completion
- 9 Jul 2022 (actual)
- Study completion
- 9 Sep 2022 (actual)
- First posted
- 23 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| volunteer for an autograft | Experimental | Procedure: collecting a Nanofat-type microfat autograftCollecting and preparing a Nanofat-type autograft using a special kit. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (24 listed)
- Thrombocytopenia < 150 G/L
- Thrombocytosis > 450 G/L
- Known thrombopathy
- TP < 70%
- APT Patient/Control ratio > 1.20
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| collecting a Nanofat-type microfat autograftCollecting 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. | Procedure or surgery | volunteer for an autograft |
Primary outcome
Appearance of nanofat autografts
Time frame: one month
Expected specification: colorless to slightly yellow
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%
Functionality of nanofat autografts
Time frame: one month
Expected specification: CFU-F > 10 per 1000 nucleated cells
Microbiological sterility of nanofat autografts
Time frame: one month
expected specification: negative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing collecting a Nanofat-type microfat autograft in people with Rhizarthrosis, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appearance of nanofat autografts (time frame: one month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.