Autologous Bone Marrow Derived Mononuclear Cells in Treating Diabetic Patients With Critical Limb Ischemia
Phase I/II Study of Regenerative Cell Therapy in Treating Diabetic Patients With Critical Limb Ischemia
2 other identifiers
interventional
20
1 country
1
Brief Summary
The aim of this study is to assess the efficacy and safety of autologous transplantation of bone-marrow cells for therapeutic angiogenesis and vasculogenesis in diabetic patients with non-revascularizable critical limb ischemia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Dec 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 30, 2009
CompletedFirst Posted
Study publicly available on registry
March 31, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedNovember 14, 2014
November 1, 2014
1.3 years
March 30, 2009
November 13, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Angiographic evaluation of angiogenesis and vasculogenesis at target limb
3 months
Secondary Outcomes (1)
Ankle-Brachial pressure index
3 months
Study Arms (1)
Autologous Bone Marrow Mononuclear Cells
EXPERIMENTALConsecutive inclusion among diabetic patients with critical limb ischemia. Intraarterial infusion of autologous bone marrow mononuclear cells
Interventions
Infusion \> 80 millions mononuclear cells. Intraarterial administration at popliteal artery level. Infusion during 3 minutes with antegrade blockage of arterial flow.
Eligibility Criteria
You may qualify if:
- Diabetic patients under treatment (type I or II)
- Critical limb ischemia (rest pain and/or non-healing ischemic ulcers lasting more than 4 weeks, and/or Ankle-Brachial Index \< 0,8)
- Not suitable to be revascularized (surgical and interventional consensus)
You may not qualify if:
- Neoplastic disease and/or hematologic disease during the last 2 years
- Diabetic retinopathy
- Ischemic ulcer greater than 10 cm2
- Major amputation at target limb
- Life expectancy \> 2 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Virgen Macarena
Seville, Seville, 41007, Spain
Related Publications (1)
Ruiz-Salmeron R, de la Cuesta-Diaz A, Constantino-Bermejo M, Perez-Camacho I, Marcos-Sanchez F, Hmadcha A, Soria B. Angiographic demonstration of neoangiogenesis after intra-arterial infusion of autologous bone marrow mononuclear cells in diabetic patients with critical limb ischemia. Cell Transplant. 2011;20(10):1629-39. doi: 10.3727/096368910X0177.
PMID: 22289660DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Antonio de la Cuesta, MD
Critical Limb Ischemia Unit. Hospital Universitario Virgen Macarena and Hospital San Lazaro
- PRINCIPAL INVESTIGATOR
Manuel Constantino, PhD
Chief of Hematology. Hospital Universitario Virgen Macarena
- PRINCIPAL INVESTIGATOR
Rafael J Ruiz-Salmeron, PhD
Chief of Endovascular Unit. Hospital Universitario Virgen Macarena
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2009
First Posted
March 31, 2009
Study Start
December 1, 2007
Primary Completion
April 1, 2009
Study Completion
May 1, 2009
Last Updated
November 14, 2014
Record last verified: 2014-11