Safety & Effectiveness of Autologous Regenerative Cell Therapy on Pain & Inflammation of Osteoarthritis of the Hip

Официальное название

Safety and Effectiveness of Autologous Regenerative Cell Therapy on Pain and Inflammation Associated With Osteoarthritis of the Hip

Обзор

This is a prospective open-label clinical study of 50 patients to determine safety and treatment potential of autologous cell therapy for pain and inflammation associated with Osteoarthritis of the hip. Follow-up will consist of a larger sample including 4,000 patients.

Подробное описание

This is a prospective open-label clinical study of 50 patients to determine safety and treatment potential of autologous cell therapy for pain and inflammation associated with Osteoarthritis of the hip. Follow-up will consist of a larger sample including 4,000 patients.

Patients will be treated for Osteoarthritis (OA) of the hip due to degeneration or chronic injury. They will be treated with autologous Stromed obtained by the Adipose Ultrasonic Cell Recovery Unit (AUCRU) and Platelet Rich Plasma (PRP) processed by the RegenLab (RegenKit BCT-3) PRP product each as direct injections to the affected joints. Patient outcomes will be tracked with laboratory tests for inflammation markers, hip disability and osteoarthritis outcome score (HOOS) questionnaires and follow up MRI's at various endpoints to 6 months. SF-36 forms (a quality of life measure) and numerical rating scales (NRS) will also be used to assess safety and efficacy of treatment, as well as any reduction in patient medication and/or delay in pending hip replacement therapy.

Вмешательства

• Биопрепарат [StroMed + platelet rich plasma (PRP)]
  Patients will be treated with autologous StroMed obtained by the Adipose Ultrasonic Cell Recovery Unit (AUCRU) and Platelet Rich Plasma (PRP) processed by the RegenLab (RegenKit BCT-3) PRP product each as direct injections to the affected joints at the time of initial treatment. Thereafter the affected joints will be treated with direct injections to the joint with Platelet Rich Plasma processed by RegenLab (RegenKit BCT-3) PRP product. Day 0 \[StroMed + platelet rich plasma (PRP)\], Day 7, 14 a

Первичные конечные точки

• Change is being assessed for the HOOS survey (Hip Osteoarthritis Outcome Scores) [Срок оценки: 0,2,6 months]

Вторичные конечные точки (3)

• Change is being assessed by MRI of afflicted joint [Срок оценки: 0 and (6 months optional)]
• Change is being assessed for the SF36 survey (Short Form Quality of Life Survey) [Срок оценки: 0,2,6 months]
• Change is being assessed for the NRS survey (Numerical Rating Scale for Pain) [Срок оценки: 0,2,6 months]

Критерии участия

Критерии включения

• Patients with indication of Osteoarthritis. Can be from degeneration or chronic injury.
• Patients range from 18-90 years of age.
• Patients must be able to comply with treatment plan, laboratory tests and periodic interviews.
• Patients with adequate renal function, Creatinine ≤ 1.5 mg/dl.
• Patients with adequate cardiac and respiratory function.
• Patients with adequate blood coagulation activity, PT(INR) < 1.5, APTT
• Patients must have adequate immune system function, with no known immunodeficiency disease.
• Greater than 6 months hip pain with the index side (left or right).

Критерии исключения

• Neoplastic cancer within 5 years prior to screening, except for cutaneous basal cell or squamous cell cancer resolved by excision
• Presence of clinically significant acute or unstable cardiovascular and cerebrovascular (stroke).
• Diagnosis of a transient ischemic attack in the 6 months prior to screening.
• Patients infected with hepatitis B, C or HIV.
• Patients with Body Mass Index (BMI) > 40kg/m2
• Presence of active infection.
• Any other illness, psychiatric disorder, alcohol or chemical dependence that in the opinion of the investigator would render a patient unsuitable to participate in the study.
• Conditions/therapies/factors which could confound or interfere with the evaluation of pain/mobility including, but not limited to:

• Treatments with strong opioid drugs in the previous 4 weeks for other pain rather than hip osteoarthritis
• Corticosteroid injection at treatment site within 1 month
• Consistent use of NSAIDs within 48 hours of procedure.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• VivaTech International, Inc. — Grove City

Идентификаторы

NCT: NCT02844764 · IRCM-2016-111

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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