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Outcomes Data of Adipose Stem Cells to Treat Osteoarthritis

28. August 2018 aktualisiert von: StemGenex

Autologous Adipose Stromal Vascular Fraction Outcomes in Osteoarthritis Research Study

The purpose of this study is to determine the impact that treatment with a cellular concentrate derived from an individual's own fat, known as the stromal vascular fraction (SVF), has on joint pain and functionality in people with Osteoarthritis (OA). SVF contains components with "regenerative" properties, including stem cells that have shown promise for ameliorating specific disease conditions. This study is designed to evaluate joint pain and functionality changes in individuals with OA for up to 12 months following SVF treatment.

Studienübersicht

Status

Unbekannt

Bedingungen

Arthrose

Studientyp

Beobachtungs

Einschreibung (Voraussichtlich)

100

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

Vereinigte Staaten
- California
  - San Diego, California, Vereinigte Staaten, 92121
    - Rekrutierung
    - StemGenex
    - Kontakt:
      
      Telefonnummer: 855-742-7836

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

Community Sample

Beschreibung

Inclusion Criteria:

Fluent in English
Over the age of 18
Diagnosed with OA of the knee and/or hip
Scheduled for intravenous and intra-articular administrations of autologous SVF
Capable of understanding and willing to sign informed consent
Willing and able to complete brief phone interviews
Willing and able to complete online surveys

Exclusion Criteria:

Co-morbidity with an autoimmune disorder
Pregnant, may become pregnant, or breastfeeding
Subjects for which baseline data is not available

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Beobachtungsmodelle: Kohorte
Zeitperspektiven: Interessent

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme	Maßnahmenbeschreibung	Zeitfenster
Change from Baseline in Overall Knee Assessment Over the Course of a 12 Month Period as Measured by the Knee Injury and Osteoarthritis Outcome Score (KOOS LK 1.0) Zeitfenster: Baseline, 12 months	The change from baseline over the course of 12 months using participants' assessment of their knee and associated problems. Mean scores will be used for baseline (day 0) and all interviews up to month 12 (months 1, 3, 6, and 12). Answer options are graded on a 5 point Likert scale and each question gets a score from 0 to 4.	Baseline, 12 months
Change from Baseline in Overall Hip Assessment Over the Course of a 12 Month Period as Measured by the Hip Dysfunction and Osteoarthritis Outcome Score (HOOS LK 2.0) Zeitfenster: Baseline, 12 months	The change from baseline over the course of 12 months using participants' assessment of their hip and associated problems. Mean scores will be used for baseline (day 0) and all interviews up to month 12 (months 1, 3, 6, and 12). Answer options are graded on a 5 point Likert scale and each question gets a score from 0 to 4.	Baseline, 12 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme	Maßnahmenbeschreibung	Zeitfenster
Change from Baseline in Knee Pain at Month 12 as Measured by Participants Using the Knee Injury and Osteoarthritis Outcome Score (KOOS LK 1.0) The Pain Subscale Zeitfenster: Baseline, Month 12	Participant assessment in the change in knee pain from baseline to month 12 using the KOOS pain subscale.	Baseline, Month 12
Change from Baseline in Function in Daily Living (ADL) at Month 12 as Measured by Participants Using the Knee Injury and Osteoarthritis Outcome Score (KOOS LK 1.0) The ADL Subscale Zeitfenster: Baseline, Month 12	Participant assessment in the change in function in daily living from baseline to month 12 using the KOOS ADL subscale.	Baseline, Month 12
Change from Baseline in Function in Sport and Recreation at Month 12 as Measured by Participants Using the Knee Injury and Osteoarthritis Outcome Score (KOOS LK 1.0) The Sport/Rec Subscale Zeitfenster: Baseline, Month 12	Participant assessment in the change in sport and recreation from baseline to month 12 using the KOOS sport/rec subscale.	Baseline, Month 12
Change from Baseline in Knee Related Quality of Life (QOL) at Month 12 as Measured by Participants Using the Knee Injury and Osteoarthritis Outcome Score (KOOS LK 1.0) The Knee Related Quality of Life Subscale Zeitfenster: Baseline, Month 12	Participant assessment in the change in knee related quality of life from baseline to month 12 using the KOOS QOL subscale.	Baseline, Month 12
Change from Baseline in Other Knee Symptoms at Month 12 as Measured by Participants Using the Knee Injury and Osteoarthritis Outcome Score (KOOS LK 1.0) The Other Symptoms Subscale Zeitfenster: Baseline, Month 12	Participant assessment in the change in other knee symptoms from baseline to month 12 using the KOOS other symptoms subscale.	Baseline, Month 12
Change from Baseline in Hip Pain at Month 12 as Measured by Participants Using the Hip Dysfunction and Osteoarthritis Outcome Score (HOOS LK 2.0) The Pain Subscale Zeitfenster: Baseline, Month 12	Participant assessment in the change in hip pain from baseline to month 12 using the HOOS pain subscale.	Baseline, Month 12
Change from Baseline in Function in Daily Living (ADL) at Month 12 as Measured by Participants Using the Hip Dysfunction and Osteoarthritis Outcome Score (HOOS LK 2.0) The ADL Subscale Zeitfenster: Baseline, Month 12	Participant assessment in the change in function in daily living from baseline to month 12 using the HOOS ADL subscale.	Baseline, Month 12
Change from Baseline in Function in Sport and Recreation at Month 12 as Measured by Participants Using the Hip Dysfunction and Osteoarthritis Outcome Score (HOOS LK 2.0) The Sport/Rec Subscale Zeitfenster: Baseline, Month 12	Participant assessment in the change in function in sport and recreation from baseline to month 12 using the HOOS sport/rec subscale.	Baseline, Month 12
Change from Baseline in Hip Related Quality of Life (QOL) at Month 12 as Measured by Participants Using the Hip Dysfunction and Osteoarthritis Outcome Score (HOOS LK 2.0) The QOL Subscale Zeitfenster: Baseline, Month 12	Participant assessment in the change in hip related quality of life from baseline to month 12 using the HOOS QOL subscale.	Baseline, Month 12
Change from Baseline in Other Hip Symptoms at Month 12 as Measured by Participants Using the Hip Dysfunction and Osteoarthritis Outcome Score (HOOS LK 2.0) The Other Symptoms Subscale Zeitfenster: Baseline, Month 12	Participant assessment in the change in other hip symptoms from baseline to month 12 using the HOOS other symptoms subscale.	Baseline, Month 12

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

StemGenex

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. September 2014

Primärer Abschluss (Voraussichtlich)

1. September 2019

Studienabschluss (Voraussichtlich)

1. September 2019

Studienanmeldedaten

Zuerst eingereicht

13. September 2014

Zuerst eingereicht, das die QC-Kriterien erfüllt hat