2024-515317-18-00招募中2 期
Tolerance of intra-articular injection of autologous stromal vascular fraction for the treatment of rhizarthrosis_FVS-RHIZA
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 3
- 主要终点
- The number of treatment-attributable Grade ≥ 3 adverse reactions occurring over a 6-month period after intra-articular injection of FVS
研究概览
简要总结
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.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •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
- •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
- •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).
排除标准
- •History of intra-articular injection of the trapezio-metacarpal (corticoid or hyaluronic acid) in the last 6 months
- •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
- •Body Mass Index < 18 kg/m2
- •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
- •Contraindication to general or local anesthetics including XYLOCAINE 10 mg/mL ADRENALINE 0.005 mg/mL, solution for injection
- •Contraindication to liposuction (eg bleeding disorder)
- •Documented severe allergy to conventional antibiotics such as β- lactams, cyclins, macrolides, quinolones, aminoglycosides, etc…
- •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
- •Prescription of a new systemic treatment that may influence the condition of the hand (vasodilator or immunosuppressant) in the 90 days preceding inclusion
- •Congenital or acquired immune deficiency
- •Known hypersensitivity to human albumin or to any of the excipients (VIALEBEX 200 g/L, solution for infusion)
- •Contraindication to sedation or general anesthesia (left to the discretion of the anesthesiologist)
- •Persons infected with HIV, HCV, HBV, HTLV I 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
结局指标
主要结局
The number of treatment-attributable Grade ≥ 3 adverse reactions occurring over a 6-month period after intra-articular injection of FVS
The number of treatment-attributable Grade ≥ 3 adverse reactions occurring over a 6-month period after intra-articular injection of FVS
次要结局
- 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)
- Assess at 1, 3 and 6 months the pain by the EVA scale and by monitoring the progress of long-term analgesic treatment
- Assess at 1, 3 and 6 months cartilage regeneration (Evaluation by MRI of the cartilage and X-ray of the trapezio-metacarpal
- Assessment of adverse events using EvI/EvIG data collection
研究者
David MALLET
Scientific
Centre Hospitalier Universitaire Rouen
研究点 (3)
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