Safety and Tolerability of StroMel™ in Subjects with Moderate to Severe Osteoarthritis of the Knee Joint

Официальное название

An Open Label Study to Evaluate Safety and Tolerability of StroMel™ in Subjects with Moderate to Severe Osteoarthritis of the Knee Joint

Обзор

The aim of this trial is to evaluate the safety and tolerability of autologous StroMel™ for the treatment of moderate to severe OA of the knee joint.

Вмешательства

• Биопрепарат StroMel
  Autologous MSC

Первичные конечные точки

• Safety of StroMel in subjects with moderate to severe OA of the kneee [Срок оценки: 12 months]
• Overall Safety of StroMel [Срок оценки: 12 months]

Вторичные конечные точки (2)

• Efficacy of StroMel in managing OA of the knee [Срок оценки: 52 weeks]
• Efficacy of StroMel in assessment of OA of the knee post-treatment [Срок оценки: 52 weeks]

Критерии участия

Критерии включения

• Adults between the ages of 25-65 years
• Body Mass Index (BMI) less than 40 kg/m2
• Ambulatory and in good general health as described by vital signs (blood pressure 90/60 mm Hg to 120/80 mm Hg, pulse rate 60-100 beats per minute, temperature 97.2-99.1 °F) and normal blood chemistry.
• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain score of ≥ 11 (worst possible = 20) over the previous 7 days
• OA of the knee with Kellgren and Lawrence radiographic classification (Grade 2-4 inclusive) within the last 6 months
• Minimum score of 40 out of possible 100 on the VAS (Visual Analog Scale) for pain.
• Patients who have failed to adequately respond for at least 6 months to at least 2 OA therapies that include conservative, non-pharmacological therapy and simple analgesics (e.g., acetaminophen); nonsteroidal anti-inflammatory drugs (NSAIDS); avoidance of activities that cause joint pain; exercise; weight loss; physical therapy; and removal of excess fluid from the knee.
• Have suitable knee joint anatomy for intra-articular injection.
• For adults of reproductive potential: use of effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation.

Критерии исключения

• Reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease.
• Subject with an infection that requires parenteral antibiotic administration.
• Active infection or crystal disease in the index joint within 1 month of screening
• History of fracture in the index limb, joint instability, or history of acute dislocation within 12 months of screening, or fracture with sequelae at any time
• Intra-articular treatment of any joint with any of the following agents within 6 months of screening: Any corticosteroid preparation (investigational or marketed), sodium hyaluronate, any biologic agent (e.g., platelet rich plasma (PRP) injection, stem cells, prolotherapy, amniotic fluid injection); investigational six months prior to enrollment.
• Presence of surgical hardware or other foreign body in the index joint
• Subjects who were administered with immunosuppressants such as cyclosporin A or azathioprine within 6 weeks before screening.
• Planned or anticipated surgery of the joint during the study period
• Allergies to anesthesia
• Subjects who tested positive for HIV, HCV, WNV, CMV, HBV, HTLV, ZIKA, syphilis, flu or COVID-19. Note: CMV is not a relevant communicable disease agent. A subject who tests positive or reactive for CMV is not necessarily ineligible. Physicians will determine donor eligibility for subjects with positive CMV test results.
• History of lipid disorders: lipedema, lipomatosis, or lipodystrophies.
• Active cancer, chemotherapy, or other malignancies in the last 6 months.
• Recent history of DVT or pulmonary embolism requiring anticoagulants or other medicines per the hematologist.
• Subject who participated in another clinical trial within 3 months before the screening visit
• Any illness which, in the Investigator's judgment, will interfere with the subject's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results.
• Subjects who are breastfeeding
• Subjects with uncontrolled arrhythmias
• Subjects with hemophilia; factor II, V, VII, X, or XII deficiencies; or Von Willebrand's disease.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Mukesh — Gaithersburg

Идентификаторы

NCT: NCT04750252 · StroMel-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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