- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00498069
Study of Autologous Bone Marrow Concentrate for the Treatment of Critical Limb Ischemia (CLI)
Feasibility Study of the Safety and Activity of Autologous Bone Marrow Aspirate Concentrate (BMAC) for the Treatment of Critical Limb Ischemia Due to Peripheral Arterial Occlusive Disease
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Florida
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Tampa, Florida, Estados Unidos, 33606
- University of South Florida Department of Vascular Surgery at Tampa General
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02111
- Tufts Medical Center
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New York
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Albany, New York, Estados Unidos, 12208
- The Vascular Group at Albany Medical Center
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Brooklyn, New York, Estados Unidos, 11219
- Maimonides Medical Center
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29401
- Roper St. Francis Hospital
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Texas
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Houston, Texas, Estados Unidos, 77030
- Methodist Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Diagnosis of Critical Limb Ischemia per protocol (see diagnostic criteria #2) with regard to the study limb.
Existence of a PAOD with clinical presentation corresponding to Rutherford Category 4 or Category 5 as defined in the reporting standards adopted by the Society of Vascular Surgeons (table 1)
Patient meets at least one of the following diagnostic criteria in the study limb:
- Ankle artery occlusion pressure absolute <50 mmHg or ABI <0.4
- Toe artery occlusive pressure < 40mm Hg or TBI (<0.4)
- TcPO2 <20 mmHg lying down breathing room air.
There is no reasonable open surgical or endovascular revascularization option as determined by the treating vascular specialist. Factors that may contribute to the determination of inoperability may include:
Anatomical considerations
- No outflow targets
- No appropriate conduit (i.e. vein for bypass)
- Long segment occlusions or calcified lesions that predict poor outcome with endovascular approaches.
High risk medical conditions
- Unstable cardiac disease.
- Renal insufficiency
- History of prior failed revascularization attempts
The patient's unsuitability must be confirmed by 2 qualified physicians.
- The attending vascular surgeon will provide the primary assessment.
- The confirmatory opinion must come from a fully licensed physician. (not a resident)
- If anatomical considerations are invoked, the second physician may be a vascular surgeon, interventional radiologist, cardiologist, or vascular medicine specialist.
- If medical co-morbidity is deemed the high risk aspect, then the confirmatory opinion may be obtained from an internist, family physician, cardiologist, vascular medicine, nephrologists, or vascular surgeon.
- Age >18 years and ability to understand the planned treatment
- Subject has read and signed the IRB approved Informed Consent form
- Patients for whom the following medication(s) is prescribed must have a one month stable baseline of appropriate/maximally tolerated therapy prior to enrollment: Plavix/asprin therapy, anticoagulation therapy, cholesterol lowering agent, and or blood pressure medication
- Hematocrit ≥ 28.0%, White Blood Cell count ≤ 14,000, Platelet count ≥ 50,000, Creatinine ≤ 2.0 mg / dL, INR ≤ 1.6 unless on Coumadin, or PTT <1.5 x control (to avoid bleeding complications) Patients on Coumadin will be corrected prior to the procedure and must have an INR<1.6 at the time of randomization/surgery.
Exclusion Criteria:
- Life expectancy <6 months due to concomitant illnesses
- History of bone marrow diseases (especially NHL, MDS) that prohibit transplantation
- Terminal renal failure with existing dependence on dialysis
- Known active malignancy or results outside of normal limits from the following tests: PAP, Chest X-ray, PSA, Mammogram, Hemoccult unless follow-up studies reveal patient to be cancer free..
- Poorly controlled diabetes mellitus (HgbA1C>10%)
- Medical risk that precludes anesthesia (conscious sedation), or ASA Class 5
- Life-threatening complications of the ischemia necessitating immediate amputation
- Uncorrected iliac artery occlusion on index side
- No Doppler signal in the foot (ABI =0)
- Extensive necrosis of the index limb or other conditions that make amputation inevitable (Rutherford Category 6)
- Active clinical infection being treated by antibiotics within one week of enrollment
- Treatment with immunosuppressant drugs (including Prednisone > 5 mg per day).
- Female who is pregnant or nursing, or of child bearing potential and is not using a reliable birth control method.
- Underwent a major open cardiovascular surgical procedure (carotid endarterectomy, arterial aneurysm or bypass surgery, or coronary artery bypass surgery) or a myocardial infarction within the 3 months prior to randomization
- Cerebrovascular accident within 6 months prior to randomization.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Comparador Ativo: 1
Injection of autologous bone marrow concentrate into ischemic tissues of the lower extremity
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injection of 40cc bmac
Outros nomes:
Injection of autologous bone marrow concentrate prepared with the SmartPReP2 BMAC System
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Comparador de Placebo: 2
Injection of placebo into ischemic tissues of the lower extremity
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injection of placebo into ischemic tissue of the lower extremity
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
---|---|
To be determined by data from this feasibility study
Prazo: 3 mos & 5 years
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3 mos & 5 years
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2007-1
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