E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Adults with a rhizarthrosis stage DELL 1 to 3 |
|
E.1.1.1 | Medical condition in easily understood language |
Adults with a rhizarthrosis stage DELL 1 to 3 |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The main objective of the research is to assess the tolerance at 6 months of intra-articular injection of FVS for the treatment of rhizarthosis.
|
|
E.2.2 | Secondary objectives of the trial |
The secondary objectives of the research are to assess at 1, 3 and 6 months:
- the efficacy of intra-articular injection of FVS on (1) functional level and on (2) pain,
- (3) cartilage regeneration after intra-articular injection of FVS. |
|
E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
To evaluate the ability of injected FVS cells to form chondroblasts in vitro |
|
E.3 | Principal inclusion criteria |
• Adult (≥ 18 years old)
• Rhizarthrosis DELL stage 1 to 3
• Symptomatic medical treatment for a period of at least 6 months (analgesic, orthosis, anti-inflammatory, etc. or intra-articular infiltration of the trapezio-metacarpal joint) which has become ineffective (surgical stage)
• EVA pain ≥ 4
• Quick Dash or PRWHE ≥ 20/100
• Affiliation to a social security scheme
• Person who has read and understood the information letter and signed the consent form
• For women :
o Woman of childbearing age with effective contraception (Cf. CTFG) (oestrogen-progestins or intrauterine device or tubal ligation) for 3 months and a negative urine pregnancy test on inclusion (V1)
o Postmenopausal woman: non-medically induced amenorrhea for at least 12 months before the inclusion visit
|
|
E.4 | Principal exclusion criteria |
• History of intra-articular injection of the trapezio-metacarpal (corticoid or hyaluronic acid) in the last 6 months
• Body Mass Index < 18 kg/m2
• Contraindication to general or local anesthetics including XYLOCAINE 10 mg/mL ADRENALINE 0.005 mg/mL, solution for injection
• Contraindication to sedation or general anesthesia (left to the discretion of the anesthesiologist)
• Contraindication to liposuction (eg bleeding disorder)
• Documented severe allergy to conventional antibiotics such as β-lactams, cyclins, macrolides, quinolones, aminoglycosides, etc…
• Known hypersensitivity to human albumin or to any of the excipients (VIALEBEX 200 g/L, solution for infusion)
• A general or local infection near the sampling or injection sites
• Any surgery scheduled over the duration of the study of the hand (carpal tunnel type operation) or upper limb that may have an impact on the assessment of pain and/or functional indices
• Persons on immunosuppressants: corticosteroid therapy > 10 mg/day, methotrexate > 25 mg/week, mycofenolate mofetil > 3 grams/day, azathioprine > 200 mg/day and intravenous cyclophosphamide and any biotherapy within 90 days preceding the medical visit. inclusion
• Congenital or acquired immune deficiency
• Prescription of a new systemic treatment that may influence the condition of the hand (vasodilator or immunosuppressant) in the 90 days preceding inclusion
• Persons infected with HIV, HCV, HBV, HTLV and syphilis
• Contraindication to MRI, (eg, due to presence of pacemakers or other incompatible foreign material or claustrophobia)
• Contraindication to the injection of gadolinated contrast product (gadolinium) for performing MRI (history of hypersensitivity to gadolinated contrast products)
• Active COVID-19 infection (PCR positive)
• Any cardiovascular, metabolic, endocrine, psychiatric or cancerous pathology in uncontrolled evolution
• Pregnant woman or woman likely to be in the absence of effective contraception (Women of childbearing age must have a negative urine pregnancy test on inclusion)
• Breastfeeding woman or absence of proven contraception
• Person deprived of liberty by an administrative or judicial decision or person placed under legal safeguard / sub-tutorship or curatorship
• Person taking part in the research participating in another trial / having participated in another trial within 6 months
• History of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for his participation in the protocol or preventing him from giving his informed consent. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the number of treatment-attributable Grade ≥ 3 adverse reactions occurring over a 6-month period after intra-articular injection of FVS. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
within 6 month period post-surgery |
|
E.5.2 | Secondary end point(s) |
The secondary endpoints are to assess at 1, 3 and 6 months:
• (1) Functional assessment of the hand:
o Kapandji score
o JAMAR and Key pinch
o Active mobility of the trapezio-metacarpal in antepulsion and abduction
o Grinding test
o DASH and PWRHE quick score
• (2) Evaluation of pain by the EVA scale and by monitoring the progress of long-term analgesic treatment
• (3) Assessment of cartilage regeneration
o Evaluation by MRI of the cartilage:
- Evaluation of intra-articular inflammation of the trapezio-metacarpal
- Control of peri-articular inflammatory areas (in particular the flexor carpi radialis or the scapho-trapezio-trapezoid)
- Assessment of cartilage thickness
- Significance of TM subluxation
o X-ray of the trapezio-metacarpal (Kapandji views):
- Evaluation of the thickness of the articular line of the trapezio-metacarpal
- Appearance or regression of signs of osteoarthritis (geode, condensation, osteophyte)
- Trapezio-metacarpal deformity (DELL classification, Appendix 1)
- Significance of TM subluxation |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
At 1, 3 and 6 months post-surgery |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The visit at 6 month post-surgery is the last visit and the end of the study. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | |