- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00518401
Combination Stem Cell Therapy for the Treatment of Severe Leg Ischemia (mesendo)
Phase I Study of A Combination Stem Cell Therapy is Safe and Feasible in the Development of Mature Stable Vessels in Ischemic Limbs
The purpose of this research study is to determine if the transplant of a combination of stem cells obtained from the bone marrow of the same patient will contribute to the formation of new blood vessels in the severely diseased ischemic limb (leg). In this study the safe use of this combination of stem cells and its effects on making new blood vessels will be evaluated.
Limb Ischemia (LI) is a severe obstruction of the arteries which seriously decreases blood flow to the extremities (mainly feet and legs) and has progressed to the point of severe pain and even skin ulcers or sores.
LI needs comprehensive treatment since the condition will not improve on its own. The overall goal of treatment is to reduce the pain and increase blood flow to improve symptoms or save the leg or feet. In many cases, current options for treatment including medications, surgery or endovascular procedures have not been successful.
In the last few years, investigators have explored therapies aimed to increase blood flow to the ischemic vessels by transplanting cells that will promote the development of new vessels in the diseased leg.
The study hypothesis is based on the concept that the process of formation of new blood vessels is complex and requires the participation of several types of stem cells and growth factors. The lack of any of these components will produce vessels which are immature and unable to provide appropriate blood supply to the leg.
Patients eligible to participate in this study are those suffering from poor circulation or severe leg blockages, which are not candidates for surgical procedures.
Once the mixture of stem cells is prepared and the patient's bone marrow is ready, cells will be transplanted into the calf muscle of the diseased leg. Clinical studies to evaluate if the transplant works and is safe will be performed up to 1 year after cell transplant.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
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Louisiana
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Covington, Louisiana, Forenede Stater, 70433
- TCA Cellular Therapy
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Males or females older than 18 years of age.
- Limb ischemia with ABI of £ 0.6 in the index lower extremity in two consecutive examinations done at least 1 week apart.
- Limb ischemia with resting ischemic pain and/or non-healing ulcers.
- Patients not considered candidates for surgical or percutaneous revascularization, due to poor target vessels, inability to cross total occlusions, or a morbidity which precludes general anesthesia
Exclusion Criteria:
- Inability to provide informed consent.
- Previous angiogenic therapy.
- Known sensitivity to gentamycin and/or amphotericin B.
- Use or expected use of antineoplastic drugs.
- Any illness which might affect the patient's survival after enrollment in the protocol.
- Any illness or significant laboratory abnormality, which in the investigator's judgment will interfere with the patient's ability to comply with the protocol, compromise the patient's safety, or interfere with the interpretation of the study results.
- No evidence of acute infection - WBC > 15000.
- WBC < 4000.
- Serum Creatinine > 3.0 mg/dL.
- Pregnant women or women planning to become pregnant.
- Recent myocardial infarction within 3 months prior to screening.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Sikkerhed
Tidsramme: 6 måneder
|
6 måneder
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Gabriel P. Lasala, MD, FACC, TCA Cellular Therapy
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2007-01-I
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Kliniske forsøg med Perifer vaskulær sygdom
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McMaster UniversityCanadian Institutes of Health Research (CIHR); Population Health Research... og andre samarbejdspartnereAktiv, ikke rekrutterendeKirurgi (hjerte) | Kirurgi (Major Vascular)Canada, Det Forenede Kongerige
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Becton, Dickinson and CompanyAfsluttetKateterrelateret komplikation | Vascular Access Site Management | DesinfektionshætteBelgien, Østrig, Spanien, Italien
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Mayo ClinicTilmelding efter invitationAnatomi af GSV for Rescue Peripheral IV AccessForenede Stater
Kliniske forsøg med Mesendo
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TCA Cellular TherapyAfsluttetKoronararteriesygdom | Koronar sygdom | Koronar arteriosklerose | Koronar aterosklerose | Koronar iskæmiForenede Stater
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TCA Cellular TherapyAfsluttetKoronararteriesygdom | Koronar sygdom | Koronar arteriosklerose | Koronar ateroskleroseForenede Stater
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TCA Cellular TherapySuspenderetKoronararteriesygdom | Koronar sygdom | Hjerte sygdom | Koronar aterosklerose | Koronar iskæmi | Blokkede arterierForenede Stater