The Safety/Efficacy of hUC Mesenchymal Stem Cells（19#iSCLife®-OA） Therapy for Patients With Osteoarthritis

Официальное название

A Clinical Research on the Safety/Efficacy of Human Umbilical Cord Mesenchymal Stem Cells（19#iSCLife®-OA） Therapy for Patients With Osteoarthritis

Обзор

The purpose of this study is verify the efficacy and safety of Human Umbilical Cord Mesenchymal Stem Cells (UC-MSC) therapy for patients with Osteoarthritis, and in addition, provide basis for exploring the treatment regimen of UC-MSC therapy in different degree of cartilage defect disease

Подробное описание

This is a random, open label, and parallel controled experiment. All patients are selected and sign consent forms, then divided into 3 groups. Doctors collect the basic information of patient. All patients receive laboratory and image examination as baseline. Then, they will give cell treatment based on the clinical protocol. Doctors have follow-up visit on 2 weeks, 1, 2, 3, 6, and 12 months after treatment, and do safety and efficacy evaluation.

Safety evaluation. Researcher collect all examination data of patients and compare with each groups. The safety tests including blood routine, urine routine, hepatorenal function, C reactive protein, erythrocyte sedimentation rate, and tumor marker, etc.

Efficacy evaluation. Based on Lysholm, the international knee documentation committee (IKDC) knee evaluation form, and Visual Analogue Scale/Score (VAS) to examine the change/improvement of knee joint function. By Magnetic Resonance Imaging (MRI) examination, grade patients with Kellgren-Lawrence Grading Scale, Assessment of Preoperative Cartilage Defect Severity (AMADEUS), and observe the change/improvement of patient.

Вмешательства

• Биопрепарат Low dose mesenchymal stem cells
  Human umbilical cord mesenchymal stem cells (SCLnow 19#): group A, 1 \* 10\^7 cells (5ml);
• Биопрепарат High dose mesenchymal stem cells
  Human umbilical cord mesenchymal stem cells (SCLnow 19#): group B, 2 \* 10\^7 cells (5ml)
• Процедура Intraarticular injection
  Intraarticular injection with human umbilical cord mesenchymal stem cells (SCLnow 19#) with different dose group

Первичные конечные точки

• Kellgren-Lawrence Grading Scale [Срок оценки: 12 months]

Вторичные конечные точки (4)

• Assessment of Preoperative Cartilage Defect Severity (AMADEUS) [Срок оценки: 12 months]
• Lysholm scoring [Срок оценки: 12 months]
• The international knee documentation committee (IKDC) knee evaluation form [Срок оценки: 12 months]
• Visual Analogue Scale/Score（VAS） [Срок оценки: 12 months]

Критерии участия

Критерии включения

• Diagnosis of Knee Osteoarthritis by Kellgren and Lawrence Grading Scale, classified with Grade 2-3
• Confirm with cartilage injury,articular cartilage part or full-thickness injury, by MR (Magnetic Resonance)
• Age <70, no serious organ dysfunction
• Over 2 years knee pain or no very effective with conservative treatments
• Knee pain of VAS (visual analog scale score) is 4 or higher
• Normal hepatic and renal function, no history of gout, rheumatoid arthritis, and autoimmune diseases, etc.
• Understand and sign the consent form of this study

Критерии исключения

• Refuse to sign the consent form, or cannot keep follow-up visit
• Age >70; Age <70, but with multiple organ failure
• Unstable vital signs (breath, blood pressure, pulse)
• Combined with knee ligament (anterior and the posterior cruciate ligament, medial and lateral collateral ligament) rupture, laxity, etc.
• Serious bleeding tendency, poor coagulation function (PTA <35%)
• Pregnant or breast feeding women, or positive pregnancy test in 7 days before treatment
• Participate other clinical experiments in 3 months
• With progressing malignant tumor
• Combined with shock and critically ill patients
• With mental disease, cannot
• With history of knee joint infection, surgery, and radiotherapy
• With immunosuppressive agents treatment in 6 weeks
• Injection with hormones and sodium hyaluronate in joint in 3 months
• Overweight expressed as body mass index (BMI) >35
• With skin disease around knee joint
• With Immunodeficiency disease, including long term use immunosuppressive agents patients
• Combined with serious infection
• With some other conditions that doctor propose not to participate

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Xiangya Hospital Central South University — Чанша

Идентификаторы

NCT: NCT03383081 · SCLnow-XY-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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