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Outcomes Data of Adipose Stem Cells to Treat Osteoarthritis

28 août 2018 mis à jour par: 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.

Aperçu de l'étude

Statut

Inconnue

Les conditions

Arthrose

Type d'étude

Observationnel

Inscription (Anticipé)

100

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

États-Unis
- California
  - San Diego, California, États-Unis, 92121
    - Recrutement
    - StemGenex
    - Contact:
      
      Numéro de téléphone: 855-742-7836

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Community Sample

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Modèles d'observation: Cohorte
Perspectives temporelles: Éventuel

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
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) Délai: 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) Délai: 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

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

StemGenex

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 septembre 2014

Achèvement primaire (Anticipé)

1 septembre 2019

Achèvement de l'étude (Anticipé)

1 septembre 2019

Dates d'inscription aux études

Première soumission

13 septembre 2014

Première soumission répondant aux critères de contrôle qualité