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liushuai8608木虫 (小有名气)
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[求助]
医学临床实验设计
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42. ADIPOA - Clinical Study. 1) Agency &Identifier Agency: University Hospital, Montpellier (First received: March 19, 2012 Last updated: December 3, 2014 Last verified: December 2014) Identifier： 2) Purpose Primary: To study the safety of a single injection of autologous adipose derived mesenchymal stromal cells (ASCs) on patients with moderate or severe osteoarthritis of the knee (OA). Secondary: To study the efficacy of a single injection of autologous adipose derived mesenchymal stromal cells on patients with moderate or severe osteoarthritis of the knee (OA). Condition Intervention Phase Osteoarthritis Biological: Autologous adipose derived stem cells administrated for intra-articular use Phase 1 Arms Assigned Interventions Experimental: Group 1 2 x 10E6 ASC intra-articular injection (5 ml) Biological: Autologous adipose derived stem cells administrated for intra-articular use Each patient will receive one single administration of the cells and will be followed for 3 months. Each patients will be follow-up during one year with routinely examinations for safety issues. The first patient will be followed during 12 weeks before inclusion of the second patient. Experimental: Group 2 10 x 10E6 ASC intra-articular injection (5 ml) Biological: Autologous adipose derived stem cells administrated for intra-articular use Each patient will receive one single administration of the cells and will be followed for 3 months. Each patients will be follow-up during one year with routinely examinations for safety issues. Experimental: Group 3 50 x 10E6 ASC intra-articular injection (5 ml) Biological: Autologous adipose derived stem cells administrated for intra-articular use Each patient will receive one single administration of the cells and will be followed for 3 months. Each patients will be follow-up during one year with routinely examinations for safety issues. 3) Criteria Inclusion Criteria: OA diagnosis should fulfil the criteria of the American College of Rheumatology (ACR) with moderate or severe medial and/ or external femorotibial knee osteoarthritis (OA) (stage 3 or 4) and indication total knee arthroplasty. Exclusion Criteria: Any disease or medication affecting the bone or cartilage metabolism, including corticoids. 4) Outcome Measures Primary Outcome Measures: • Recording of Serious Adverse Events [ Time Frame: during 365 days following injection ] [ Designated as safety issue: Yes ] Adverse events will be described with respect to seriousness, intensity, relationship to treatment, action taken and outcome of the adverse event. Secondary Outcome Measures: • Functional status of the knee [ Time Frame: during 365 days following injection ] [ Designated as safety issue: Yes ] Efficacy will be assessed by measuring: o WOMAC (Western Ontario and McMaster Universities osteoarthritis index), o Short Arthritis assessment Scale (SAS), o range of motion of the target knee joint, o imaging through MRI evaluation, dGEMRIC and T1rho MRI. • Quality of life [ Time Frame: during 365 days following injection ] [ Designated as safety issue: No ] Quality of life will be assessed by measuring: o pain-specific assessment o global patient assessment (visual analog scale, Short-Form 8) o decrease in rescue paracetamol medication. |
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