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临床试验/EUCTR2015-002125-19-IE
EUCTR2015-002125-19-IE进行中（未招募）1 期

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 153 人开始时间: 2016年10月5日最近更新:
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适应症

试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
153
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • •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 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:
  • •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

排除标准

  • •1)Previous treatments acting on cartilage or bone metabolism (eg, oral or intravenous bisphosphonates <1 year previously, denosumab < 6 months, strontium ranelate or teriparatide or raloxifene <7 days prior to selection, and oral glucosamine =1500 mg/day or chondroitin sulphate =1000 mg/day <3 months previously)
  • •2)Has had any trauma of the index knee in the previous 12 months prior to the screening visit
  • •3)Has OA of the index knee that meets K-L classification criteria of grade 1 or 4
  • •4)Osteoarthritis causing significant pain in any joint other than the identified knee, i.e., pain in hip, or contralateral knee (= 20 mm pain) as confirmed by a separate VAS at baseline for any other painful joint concerned
  • •5)Significant trauma or surgery to the index knee within the last year or arthroscopy of the index knee within 12 months of screening (Not applicable in Germany and Netherland)
  • •6)Prior to the screening visit, has received:-Oral corticosteroid therapy within the previous 3 month, OR-Intramuscular, intravenous or epidural corticosteroid therapy within the previous 6 months, OR-Intra-articular injection of corticosteroids in the index within the previous 6 months, OR
  • •-Intra-articular injection of hyaluronic acid in the index knee within the 6 months. OR-Intra-articular injection of platelet rich plasma in the index knee within the 6 months.
  • •7)Inflammatory or other rheumatic diseases defined by clinical examination and previous serum markers (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)), History or evidence of infectious arthritis, Paget’s disease, Ochronosis, Wilson’s Disease, Primary osteochondromatosis
  • •8)History of articular fracture of the target knee joint
  • •9)History of heritable disorders (e.g. hypermobility) and collagen gene mutations
  • •10)Immunodeficiency diseases
  • •11)Alcoholics not in treatment and still drinking (14+ drinks/week)
  • •12)Subjects with poorly controlled diabetes mellitus (HbA1C > 8%) or known concomitant vascular problems
  • •13)Planned longer stay outside the region that prevents compliance with the scheduled visit
  • •14)Severe misalignment of the knee (excessive varus or valgus = 8°) at physical examination, as confirmed by standard radiograph
  • •15)Severe osteoporosis with previous symptomatic vertebral or hip fractures
  • •16)History of joint replacement of the knee or hip within the previous 12 months
  • •17)Serious systemic diseases or infectious/inflammatory skin diseases in the area of the affected knee
  • •18)Positive serology for HIV, hepatitis B, C and syphilis
  • •19)History of cancer or blood dyscrasias, or previous chemotherapy, radiotherapy or immunotherapy
  • •20)Contraindication to MRI, including MRI-incompatible internal devices (pacemaker, neurostimulator, cochlear implant, ocular foreign bodies, foreign bodies close to neurovascular structures)
  • •21)Intolerance or allergy to local anaesthesia
  • •22)Anticoagulant treatment
  • •23)Overweight with body mass index greater than 35 (obesity grade II).
  • •25)Abnormal blood tests:
  • •-Hepatic (alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST] > 2 × upper limit of normal [ULN]),-Renal (clearance < 30 ml/min/1,73 m2),pancreatic or biliary disease, except asymtomatic bile stones-Blood coagulation disorders, Anaemia (= 10 g/dL) or platelet count of = 100 × 109/L
  • •26)Significant

研究者

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