A phase IIb, prospective, multicentre, double-blind, triple-arm, randomized versus placebo trial, to assess the efficacy of a single injection of either 2 or 10 x 106 autologous adipose derived mesenchymal stromal cells (ASC) in the treatment of mild to moderate osteoarthritis (OA) of the knee, active and unresponsive to conservative therapy for at least 12 months. - ADIPOA 2

CHU Montpellier0 个研究点目标入组 150 人开始时间: 2017年1月3日最近更新: 2017年7月3日

适应症

试验速览

暂无简介。

•1.Symptomatic mild to moderate osteoarthritis (OA) of the index knee as defined by the American college of Rheumatology (ACR):
•- History of pain in the index knee = 6 months, AND
•- Kellgren-Lawrence (K-L) Grade 2 or 3 only, on plain radiographs of the index knee (including fixed flexion), AND
•- Swelling of the index knee evaluated by the investigator
•2.Must meet the following pain criteria at the time of screening/baseline visit since at least half of the days in the previous month:
•- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscores = 40 mm on the 0-100 normalised scale
•- Visual Analogic Scale (VAS) pain rating of at least 40 on a 100-mm scale
•- Subject’s global assessment of arthritis status must be fair, poor, or very poor
•-Subject’s global assessment of the contralateral knee <20 mm by 100-mm using Visual Analogic Scale (VAS)
•3.NSAID washout of at least 2 days before screening/baseline
•4. BMI between 20-35 kg/m2
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 45
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 70

•1.Previous treatments acting on cartilage or bone metabolism (eg, oral or intravenous bisphosphonates <1 year previously, strontium ranelate or teriparatide or raloxifene <7 days prior to selection, and oral glucosamine =1500 mg/day and chondroitin sulphate <3 months previously)
•2.Prior to the screening visit, has received intra-articular injection of corticosteroids, platelet rich plasma or hyaluronic acid within the previous 6 months,
•3.Significant trauma or surgery to the index knee within the last year or arthroscopy of the index knee within 12 months of screening.
•4.Kellgren-Lawrence Grade 1 or 4 in the index knee.
•5.Osteoarthritis causing significant pain in any joint other than the identified knee, i.e., pain in hip, back, or contralateral knee (= 20 mm pain) as confirmed by a separate VAS at baseline for any other painful joint concerned
•6.History of joint replacement of the knee or hip within the ?previous 12 month
•7.Diagnosis of one or more of the following:
•- Inflammatory arthritis such as rheumatoid arthritis, autoimmune disorder, seronegative spondyloarthritis, gout or pseudogout (defined as acute episodic attacks of swollen, painful joint in a patient with X-Ray chondrocalcinosis or CPPD crystals);
•- Severe misalignment of the knee (excessive varus or valgus = 8°) at physical examination, as confirmed by standard radiograph
•- Severe osteoporosis with previous fractures

发起方