Tolerance of intra-articular injection of autologous stromal vascular fraction for the treatment of rhizarthrosis_FVS-RHIZA

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire Rouen

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

Trial duration

26 Oct 2023 → ongoing

Decision date (initial)

2024-09-24

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-515317-18-00

EudraCT number

2022-001784-27

ClinicalTrials.gov

NCT05708430

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy, Safety

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.

Secondary objectives 4

1. Assess at 1, 3 and 6 months the efficacy of intra-articular injection of FVS on functional level
2. Assess at 1, 3 and 6 months the efficacy of intra-articular injection of FVS on pain
3. Assess at 1, 3 and 6 months the efficacy of intra-articular injection of FVS on cartilage regeneration after intra-articular injection of FVS.
4. Assess at 1, 3 and 6 months the tolerance of intra-articular injection of FVS

Conditions and MedDRA coding

Adults with a rhizarthrosis stage DELL 1 to 3

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. Adult (≥ 18 years old)
2. Rhizarthrosis DELL stage 1 to 3
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)
4. EVA pain ≥ 4
5. Quick Dash or PRWHE ≥ 20/100
6. Affiliation to a social security scheme
7. Person who has read and understood the information letter and signed the consent form
8. 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
9. For men: Surgical sterility, or mechanical contraception (condom) for the duration of the study, or with a partner of childbearing age taking effective contraception (Cf. CTFG) (estrogen-progestin or intrauterine device or tubal ligation) for at least 3 months at inclusion and for the duration of the study, or with a postmenopausal partner: confirmatory diagnosis (non-medically induced amenorrhea for at least 12 months prior to the inclusion visit).

Exclusion criteria 22

1. History of intra-articular injection of the trapezio-metacarpal (corticoid or hyaluronic acid) in the last 6 months
2. Prescription of a new systemic treatment that may influence the condition of the hand (vasodilator or immunosuppressant) in the 90 days preceding inclusion
3. Persons infected with HIV, HCV, HBV, HTLV I and syphilis
4. Contraindication to MRI, (eg, due to presence of pacemakers or other incompatible foreign material or claustrophobia)
5. Contraindication to the injection of gadolinated contrast product (gadolinium) for performing MRI (history of hypersensitivity to gadolinated contrast products)
6. Active COVID-19 infection (PCR positive)
7. Any cardiovascular, metabolic, endocrine, psychiatric or cancerous pathology in uncontrolled evolution
8. 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)
9. Breastfeeding woman or absence of proven contraception
10. Person deprived of liberty by an administrative or judicial decision or person placed under legal safeguard / sub-tutorship or curatorship
11. Person taking part in the research participating in another trial / having participated in another trial within 6 months
12. Body Mass Index < 18 kg/m2
13. 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
14. Contraindication to general or local anesthetics including XYLOCAINE 10 mg/mL ADRENALINE 0.005 mg/mL, solution for injection
15. Contraindication to liposuction (eg bleeding disorder)
16. Documented severe allergy to conventional antibiotics such as β- lactams, cyclins, macrolides, quinolones, aminoglycosides, etc…
17. A general or local infection near the sampling or injection sites
18. 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
19. 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
20. Congenital or acquired immune deficiency
21. Known hypersensitivity to human albumin or to any of the excipients (VIALEBEX 200 g/L, solution for infusion)
22. Contraindication to sedation or general anesthesia (left to the discretion of the anesthesiologist)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The number of treatment-attributable Grade ≥ 3 adverse reactions occurring over a 6-month period after intra-articular injection of FVS

Secondary endpoints 4

1. Assess at 1, 3 and 6 months functional assessment of the hand (Kapandji score, JAMAR and Key pinch, Active mobility of the trapezio-metacarpal in antepulsion and abduction, Grinding test, DASH and PWRHE quick score)
2. Assess at 1, 3 and 6 months the pain by the EVA scale and by monitoring the progress of long-term analgesic treatment
3. Assess at 1, 3 and 6 months cartilage regeneration (Evaluation by MRI of the cartilage and X-ray of the trapezio-metacarpal
4. Assessment of adverse events using EvI/EvIG data collection

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire Rouen

Sponsor organisation

Centre Hospitalier Universitaire Rouen

Address

1 Rue De Germont, Bp 96031 Bp 96031

City

Rouen Cedex

Postcode

76031

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire Rouen

Contact name

David MALLET

Public contact point

Organisation

Centre Hospitalier Universitaire Rouen

Contact name

David MALLET

Locations

1 EU/EEA country · 3 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Unexpected events 1 · Art. 53 CTR

Note: SUSARs are reported via EudraVigilance, not CTIS — events shown here are CTIS-public notifications only.

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications