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Идёт набор NCT04684602

Mesenchymal Stem Cells for the Treatment of Various Chronic and Acute Conditions

Фаза I / Фаза II С лечением Autoimmune Diseases Cardiovascular Disorders Diabetes Complications Integumentary Disease

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: PrimePro™/ PrimeMSK™.
Кому может быть актуально
Состояния в реестре: Autoimmune Diseases, Cardiovascular Disorders, Diabetes Complications, Integumentary Disease. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Evaluation of the Safety, Tolerability and Efficacy of Regenerative Therapy for the Treatment of Various Chronic and Acute Conditions

Обзор

This multi-arm, multi-site study investigates the safety, tolerability, and efficacy of stem cell therapy for the treatment of various acute and chronic conditions. Clinically observed initial findings and an extensive body of research indicate regenerative treatments are both safe and effective for the treatment of multiple conditions.

Подробное описание

This multi-arm, multi-site study investigates the safety, tolerability, and efficacy of stem cell therapy for the treatment of various acute and chronic conditions. Clinically observed initial findings and an extensive body of research indicate regenerative treatments are both safe and effective for the treatment of multiple conditions.

This study investigates clinical outcomes of treatments for numerous indications including: Autoimmune, Cardiovascular, Diabetes, Integumentary, Neurologic / Neurodegenerative, Pulmonary, Orthopedic Diseases, Sexual Dysfunction, Urologic Disorders and Viral Illnesses.

Our hypotheses posit that regenerative treatments are both safe and statistically beneficial for a range of conditions. Outcomes will be determined by multiple valid outcome instruments that measure general quality of life information along with condition-specific information.

Вмешательства

  • Биопрепарат PrimePro™/ PrimeMSK™
    Injection via condition specific route of administration.

Первичные конечные точки

  • Assessment of quality of life (QOL) via 36-Item Short Form Survey (SF-36) change from baseline at 6 and 12 months. [Срок оценки: Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.]
  • Assessment of disabilities of arm, shoulder, hand via DASH Questionnaire change from baseline at 6 and 12 months. [Срок оценки: Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.]
  • Assessment of erectile function via International Index of Erectile Function (IIEF-5) change from baseline at 6 and 12 months. [Срок оценки: Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.]
  • Assessment of COPD via Clinical Chronic Obstructive Pulmonary Disease Questionnaire change from baseline at 6 and 12 months. [Срок оценки: Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.]
  • Assessment of mental state via Mini Mental State Examination (MMSE) change from baseline at 6 and 12 months. [Срок оценки: Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.]
  • Assessment of interstitial cystitis via O'Leary/Sant Questionnaire change from baseline at 6 and 12 months. [Срок оценки: Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.]
  • Assessment of back pain via Oswestry Low Back Pain Disability Questionnaire change from baseline at 6 and 12 months. [Срок оценки: Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.]
  • Assessment of osteoarthritis via Western Ontario and McMaster Osteoarthritis Index (WOMAC) change from baseline at 6 and 12 months. [Срок оценки: Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.]

Критерии участия

Критерии включения

  • Age 18 and older
  • Ability to provide informed consent
  • Availability for follow up visits

Критерии исключения

  • Active or recent malignancy (within last 2 years)
  • Pregnancy or breast-feeding
  • Inability to provide informed consent

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Southern California Hospital at Culver City / Southern California Hospital at Hollywood / — Culver City

Идентификаторы

NCT: NCT04684602 · ICSS-2020-032

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗