Safety and Efficacy of Adipose Derived Stem Cells for Chronic Obstructive Pulmonary Disease
21. november 2017 opdateret af: Ageless Regenerative Institute
An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Effects of Intra-venous and Inhalation Implantation of Autologous Adipose-Derived Stromal Vascular Fraction Cells in Patients With Chronic Obstructive Pulmonary Disease
The intent of this clinical study is to answer the questions: 1) Is the proposed treatment safe and 2) Is treatment effective in improving the health of patients with human Chronic Obstructive Pulmonary Disease.
Studieoversigt
Status
Trukket tilbage
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This will be an open-label, non-randomized multi-center patient sponsored study of Autologous SVF (AD-SVF) implantation after liposuction using an IV delivery system and Inhalation infusion. AD-SVF will be derived from the patient's adipose-derived tissue. Liposuction using local anesthesia and syringe collection will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells. The cells will be delivered intravenously.
The adipose tissue specimen will be collected from the patient's abdomen or applicable area using tumescent syringe liposuction. The adipose tissue is transferred to the laboratory for separation of the adipose tissue-derived stem cells, which are then transferred for IV delivery. The number of cells injected will vary depending on the amount of tissue processed and the number of cells obtained from the process.
Undersøgelsestype
Interventionel
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Florida
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Aventura, Florida, Forenede Stater, 33180
- Ageless Regenerative Institute LLC
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- A prior diagnosis of moderate or severe COPD
- GOLD III and IV
- Age between 25 and 80 years
- Up to date on all age and gender appropriate cancer screening per American Cancer Society
Exclusion Criteria:
- Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
- Life expectancy < 6 months due to concomitant illnesses.
- Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.
- Active infectious disease patients known to have tested positive for HIV, HTLV, HBV, HCV, CMV (IgM > IgG) and/or syphilis. will have an expert consulted as to patient eligibility based on the patient's infectious status
- Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
- Patients on chronic immunosuppressive transplant therapy
- Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate.
- Severe asthma that would contraindicate surgery
- History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years.
- Unwilling and/or not able to give written informed consent.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Intravenous Injection and Inhalation infusion of AD-SVF
AD-SVF harvested from Autologous Adipose Tissue will be deliver after processing via IV and Inhalation
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Patients undergo a liposuction under local Anethesia.
The AD-SVF are then isolated and infused IV and by inhalation delivery.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Functional Capacity improved compared to baseline
Tidsramme: 3 months, 6 months
|
6 Minute Walk Test
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3 months, 6 months
|
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Number of adverse events
Tidsramme: 3 months, 6 months
|
3 months, 6 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Quality of Life improved compared to baseline
Tidsramme: 3 months, 6 months
|
St. George Respiratory Questionnaire
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3 months, 6 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. marts 2014
Primær færdiggørelse (Forventet)
1. november 2017
Studieafslutning (Forventet)
1. december 2017
Datoer for studieregistrering
Først indsendt
19. marts 2012
Først indsendt, der opfyldte QC-kriterier
20. marts 2012
Først opslået (Skøn)
21. marts 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
24. november 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
21. november 2017
Sidst verificeret
1. september 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- AD-US-COPD-001
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
UBESLUTET
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