ZofinTM (Organicell™ Flow) to Treat COPD

Overview

Información sobre este estudio

The purpose of this study is to demonstrate the safety of intravenous infusion (IV) of allo Human Amniotic Fluid (HAF) in subjects with Chronic Obstructive Pulmonary Disease(COPD).

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

  • Age eligible for study:  40 to 80 years.
  • Gender eligible for study:  All.
  • Subjects with moderate-to-severe COPD.
  • Subject must have a post-bronchodilator FEV1/FVC ratio of less than 0.7.
  • Subject must have a post-bronchodilator FEV1percent predicted value < 50%.
  • Subject must have a RV/TLC ratio of > 40%.
  • Subject must be an ex-smoker, with a cigarette smoking history of ≥ 10 pack-years.
  • Subject must have abstained from nicotine products for at least six months prior to enrollment in the study.
  • Subject must have a calculated creatinine clearance of greater than 30 ml/min.
  • Subject must be available for all specified assessments at the study site through the completion of the study.
  • Subject must provide written ICF and authorization for use of and disclosure of PHI. 
  • Subjects must have oxyhemoglobin saturation on room air at rest equal or greater than 88% without oxygen.
  • Subjects must speak, read and understand English.
  • Subjects must be reasonably able to return for multiple follow-up visits.

Exclusion Criteria:

  • Patients with clinically significant illness with manifestations of significant organ dysfunction which in the judgment of the PI or co-investigator would render the study subject unlikely to tolerate the infusion or complete the study.
  • Subject has been diagnosed with a pulmonary disease other than COPD (e.g., asthma, pulmonary, fibrosis, sarcoidosis, pulmonary hypertension, bronchiolitis, interstitial lung disease) Subject has been diagnosed with α1-Antitrypsin deficiency.
  • Subject has a body mass index greater than 42 kg/m^2.
  • Subject has or had an active infection requiring systemic antibiotics within 12 weeks on enrollment in the study.
  • Subject has had exacerbation of COPD requiring hospitalization within 12 weeks of enrollment in the study.
  • Subject has initiated pulmonary rehabilitation within 12 weeks of enrollment in the study.
  • Subject uses or used prednisone (or equivalent dose of another corticosteroid) within 12 weeks of enrollment in the study.
  • Subject has evidence or history of malignancy.
  • Subject has evidence or history of autoimmune disorders independent of COPD Subject is pregnant or breast-feeding.
  • Subject has evidence of liver dysfunction manifested as alkaline phosphatase greater than 345 u/L, total bilirubin greater than 1.65 mg/dL, ALT greater than 275 units/L.
  • Subject has evidence of significant and unstable cardiac dysfunction; e.g. acute myocardial infarction and hypertension with blood pressure over 180/120.
  • Subjects with pulmonary lobectomy or lung volume reduction surgery or lung transplantation. Subjects with clinically significant bronchiectasis.
  • Subject received an experimental therapy (drug or biologic for any indication within 12 months of the study enrollment.
  • Subject is unable to complete all the testing required for the study.
  • Subjects who are on immunosuppressive medications.
  • Subjects that are unwilling to stop taking prescription or over the counter pain medication for 7 days prior to any visit.
  • Subjects with a history of bleeding disorders, anticoagulation therapy that cannot be stopped as prior to injection.
  • Organ transplant recipient.
  • Medical condition that limits expectant lifespan to < 1 year.
  • Subject has a history of HIV, Hepatitis B and/or Hepatitis C or serum positive for HIV, hepatitis HBsAg, or Hepatitis C.
  • A history of drug or alcohol abuse within the past 24 months.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Scottsdale/Phoenix, Ariz.

Investigador principal de Mayo Clinic

Bruce Johnson, Ph.D.

Abierto para la inscripción

Contact information:

Emily Frank R.N., CCRN, PCCN

(480) 301-6198

Frank.Emily1@mayo.edu

More information

Publicaciones

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