NCT07542808招募中2 期
An Open-Label, Double-Treatment Group Study to Evaluate the Efficacy and Safety of Human Allogeneic Bone-Marrow- Derived Mesenchymal Stromal Cell Product StromaForte Compared With Hyaluronic Acid for the Treatment of Knee Osteoarthritis
Cellcolabs Clinical SPV Limited1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2026年4月27日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- To show that StromaForte single dose treatment provides superior pain reduction from baseline to 6 months post-injection compared to hyaluronic acid single dose treatment.
研究概览
简要总结
StromaForte injection for knee OA
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to provide written informed consent and comply with all procedures required by the protocol.
- •Aged ≥ 18 years at the time of signing the informed consent form.
- •Diagnosed with knee osteoarthritis (OA) based on the criteria established by the American College of Rheumatology, confirmed through radiological images no older than three months.
- •Grade I to IV osteoarthritis on the Kellgren-Lawrence radiological classification scale.
- •Joint pain during activity as assessed by the Visual Analogue Scale (VAS) of ≥ 40 at the time of screening
- •Body Mass Index (BMI) between ≥ 18.5 to ≤ 35.0 kg/m2
排除标准
- •Unwilling or unable to perform any of the assessments required by the protocol.
- •Mechanically unstable knee due to the presence of a complete anterior cruciate ligament, posterior cruciate ligament, medial collateral ligament and/or posterolateral corner tear.
- •Varus or valgus malalignment >5 degrees as measured by 4-foot standing antero-posterior radiographs.
- •History of subtotal medial or lateral meniscectomy performed less than 9 months ago.
- •History of septic arthritis in the targeted knee.
- •History of infectious or inflammatory joint disorders or suspected infective or inflammatory joint disease.
- •Systemic or intra-articular injection of corticosteroids in any joint within 3 months before screening.
- •Immunosuppression due to illness or medication including but not limited to high dose corticosteroids, calcineurin inhibitors, anti-TNF, anti-IL-6, anti-p40, biologics and prednisone and/or equivalent over 5 mg/day.
- •Planned orthopaedic surgery on lower limbs within the next 12 months
- •Active or suspected infection.
- •History of malignancy in the past 2.5 years, except in-situ cancers treated by local excision with curative intent.
- •Severe bleeding diathesis.
- •Participation in another clinical trial including treatment with a different investigational product within 30 days prior to inclusion in this study.
- •Pregnancy or breastfeeding.
- •Unwilling or for medical reason not recommended to pause anticoagulant medications prior to procedure, as judged by prescribing doctor.
- •Known diagnosis of HIV-1, HIV-2, Hepatitis A, Hepatitis B, Hepatitis C, HTLV-I/II, or Syphilis, or other acute or chronic infectious disease.
- •Pulmonary embolism, deep vein thrombosis or other serious embolic disease within the past 4 months.
- •Known allergies or hypersensitivity to DMSO, human serum albumin, heparin or PlasmaLyte.
- •History or current evidence of any condition, therapy, laboratory abn ormality, or other circumstance that might confound the results of the study or interfere with the study participant's participation for the full duration of the study.
- •Cognitive or language barriers that prohibit obtaining informed consent, questionnaires or any study elements.
- •Recipient of any stem cell therapy within the previous 12 months
研究组 & 干预措施
Hyaluronic Acid
Active Comparator
Hyaluronic Acid
干预措施: Hyaluronic Acid (HA) (Other)
StromaForte- Mesenchymal Stem cells
Experimental
Human Allogenic Bone marrow derived Mesenchymal Stem cells
干预措施: Mesenchymal Stem Cells (MSC) (Other)
结局指标
主要结局
To show that StromaForte single dose treatment provides superior pain reduction from baseline to 6 months post-injection compared to hyaluronic acid single dose treatment.
时间窗: "From enrollment to the end of follow-up at 1 year
Change from baseline in subjective pain during activity assessment according to the Visual Analogue Scale (VAS) questionnaire at 6 months ±30 days post-injection.
次要结局
- To evaluate the effect of StromaForte single dose treatment on pain reduction from baseline to 3 months and 12 months post-injection, compared to hyaluronic acid single dose treatment.(From enrollment to the end of follow-up at 1 year)
- To evaluate the effect of StromaForte single dose treatment on improvement of the patient's functional ability at 3 months, 6 months and 12months post-injection, compared to hyaluronic acid single dose treatment.(From enrollment to the end of follow-up at 1 year)
研究者
研究点 (1)
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