Intraarterial Infusion of Autologous Marrow Derived Mononuclear Cells in Diabetic Patients With Chronic Critical Limb Ischemia
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Fundación Pública Andaluza Progreso y Salud.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Fundación Pública Andaluza Progreso y Salud
Collaborator:
Fondo de Investigacion Sanitaria
Information provided by:
Fundación Pública Andaluza Progreso y Salud
ClinicalTrials.gov Identifier:
NCT00987363
First received: September 29, 2009
Last updated: August 1, 2011
Last verified: January 2011
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Purpose
The aim of the study is to asses the safety and efficacy of the intraarterial infusion of autologous bone marrow mononuclear cells in diabetic patients with chronic critical limb ischemia without revascularization options. The investigators hypothesize that this approach can be safe and can induce neoangiogenesis in the ischemic limb. Sixty patients will be randomly assigned to receive three different doses of marrow mononuclear cells or no intervention. During one year follow-up, clinical,angiologic and angiographic measures will be monitored to asses the impact of the cell infusion on the evolution of the ischemic limb.
| Condition | Intervention | Phase |
|---|---|---|
|
Arterial Occlusive Disease Diabetic Foot |
Other: Intraarterial infusion of autologous bone marrow cells |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase 1/2 Clinical Trial of Therapeutic Angiogenesis With Autologous Bone Marrow-derived Mononuclear Cells in Diabetic Patients With Chronic Critical Limb Ischemia Without Revascularization Options |
Resource links provided by NLM:
Further study details as provided by Fundación Pública Andaluza Progreso y Salud:
Primary Outcome Measures:
- Number of adverse events [ Time Frame: 24 h, 1,3 ,6 ,9 and 12 months ] [ Designated as safety issue: Yes ]
- Arteriographic, AngioRNM and AngioTC changes [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Clinically objective improvement in the ischemic limb [ Time Frame: 1, 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Low dose
The dose of infused cells is 1x10 E8
|
Other: Intraarterial infusion of autologous bone marrow cells
Autologous bone marrow-derived mononuclear cells will be infused by an intraarterial catheter into de ischemic limb. The number of infused cells will be 1x10 E8, 5x10E8 and 1x10 E9 in the low,intermediate and high dose arms respectively
|
|
Experimental: Intermediate dose
The dose of infused cells is 5x10 E8
|
Other: Intraarterial infusion of autologous bone marrow cells
Autologous bone marrow-derived mononuclear cells will be infused by an intraarterial catheter into de ischemic limb. The number of infused cells will be 1x10 E8, 5x10E8 and 1x10 E9 in the low,intermediate and high dose arms respectively
|
|
Experimental: High dose
The dose of infused cells is 1x10 E9
|
Other: Intraarterial infusion of autologous bone marrow cells
Autologous bone marrow-derived mononuclear cells will be infused by an intraarterial catheter into de ischemic limb. The number of infused cells will be 1x10 E8, 5x10E8 and 1x10 E9 in the low,intermediate and high dose arms respectively
|
| No Intervention: Control |
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Type 1 or 2 diabetes mellitus
- Grade II-III Rutherford-Becker peripheral vascular disease affecting at least one limb
- Arterial obstruction(s) located at infrapopliteal level
- No options of endoarterial or surgical revascularization
- Life expectancy more than 2 years
- Unlikelihood of major amputation of the leg during the next 12 months
- Normal analytical parameters in blood: leucocytes>3000/micoL, neutrophils>1500 microL, Hb>10mg/dl, platelets>100000 microL,AST and ALT<2.5 standard value, creatinin<2.5 mg/dl
- Written informed consent
- Negative pregnancy test when applicable
Exclusion Criteria:
- History of neoplasm or hematological disease
- Uncontrolled high blood pressure (>180/110)
- Severe cardiac insufficiency (NYHA IV) or ejection fraction<30%
- Malignant ventricular arrythmia
- Deep venous thrombosis during the last 3 months
- Active bacterial infection
- Treatment with hyperbaric oxygen, vasoactive drugs, Cox-II inhibitors or antiangiogenic agents
- Body mass index > 40
- Alcoholism
- Proliferative retinopathy
- HIV, HBV or HCV viral infection
- Stroke or myocardial infarction during the last 3 months
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00987363
Locations
| Spain | |
| Hospital Universitario Reina Sofia | |
| Cordoba, Spain, 14004 | |
| Hospital Universitario San Cecilio | |
| Granada, Spain, 18012 | |
| Hospital Universitario Morales Meseguer | |
| Murcia, Spain, 30008 | |
| Hospital Universitario Virgen del Rocio | |
| Sevilla, Spain, 41013 | |
Sponsors and Collaborators
Fundación Pública Andaluza Progreso y Salud
Fondo de Investigacion Sanitaria
Investigators
| Study Director: | Inmaculada Herrera, MD, PhD | Hospital Universitario Reina Sofia |
| Principal Investigator: | Francisco Tadeo Gomez, MD, PhD | Hospital Virgen del Rocio |
| Principal Investigator: | Jose Patricio Linares, MD, PhD | Hospital Universitario San Cecilio |
| Principal Investigator: | Diego Martinez, MD, PhD | Hospital Universitario Morales Messeguer |
| Principal Investigator: | Antonio Chacon, MD, PhD | Hospital Universitario Reina Sofia |
| Principal Investigator: | Jose Garcia-Revillo, MD,PhD | Hospital Universitario Reina Sofia |
| Principal Investigator: | Miguel Canis, MD | Hospital Universitario Reina Sofia |
| Principal Investigator: | Pablo Gonzalez, MD | Hospital Universitario San Cecilio |
| Principal Investigator: | Salvador Oyonarte, MD | CRTS Granada |
| Principal Investigator: | Eduardo Ros, MD,PhD | Hospital Universitario San Cecilio |
| Principal Investigator: | Rafael Ros, MD,PhD | Hospital Universitario San Cecilio |
| Principal Investigator: | Magdalena Carmona, MD | Hospital Universitario Virgen del Rocio |
| Principal Investigator: | Javier Peiro, MD | Hospital Universitario Virgen del Rocio |
| Principal Investigator: | Ricardo Asensio, MD | Hospital Universitario San Cecilio |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00987363 History of Changes |
| Other Study ID Numbers: | CMMo/ICPC/2008, EudraCT 2008-004064-39 |
| Study First Received: | September 29, 2009 |
| Last Updated: | August 1, 2011 |
| Health Authority: | Spain: Spanish Agency of Medicines |
Keywords provided by Fundación Pública Andaluza Progreso y Salud:
|
critical limb ischemia diabetic foot bone marrow derived mononuclear cells cell therapy |
Additional relevant MeSH terms:
|
Arterial Occlusive Diseases Ischemia Diabetic Foot Vascular Diseases Cardiovascular Diseases Pathologic Processes Diabetic Angiopathies Foot Ulcer |
Leg Ulcer Skin Ulcer Skin Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Diabetic Neuropathies |
ClinicalTrials.gov processed this record on May 19, 2013