Status:
COMPLETED
Autologous Transplantation of Bone Marrow Mononuclear Cell (BM-MNC) With and Without Granulocyte-Colony Stimulation Factor (G-CSF) for Treatment of Chronic Lower Limb Ischemic Patients
Lead Sponsor:
Royan Institute
Collaborating Sponsors:
Tehran University of Medical Sciences
Conditions:
Peripheral Vascular Diseases
Ischemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to investigate the efficacy and safety of autologous transplantation of mononuclear cells with and without G-CSF in patients with chronic lower limb ischemia.
Detailed Description
Critical limb ischemia (CLI) results from severe occlusive disease that impairs distal limb perfusion to the point where oxygen delivery is no longer adequate to meet the metabolic needs of the tissue...
Eligibility Criteria
Inclusion
- Presence of Critical Limb ischemia according to the guidelines of the Transatlantic Consensus Group (TASC) Rutherford grade II or III. Perfusion is measured with absolute perfusion pressure and ankle-brachial index (ABI) and transcutaneous oxygen tension (TcpO2); for inclusion, ABI has to be less than or equal to 0.6 or absolute ankle pressure must be less than 60 mmHg. If ABI is technically not feasible, e.g. in patients with media calcification, inclusion criteria are a tcpO2 value (supine, forefoot, 44°C) of less than 20 mmHg if there is no tissue loss, or a tcpO2 of less than 40 mmHg if there is tissue loss.
- No sufficient response to best standard care delivered for six weeks.
- No surgical or radiological interventional option for revascularisation as confirmed by a vascular surgeon and an interventional radiologist
- Signed informed consent
- Absence of life-threatening complications from the ischemic limb
Exclusion
- Expected life span less than six months
- Bone marrow diseases which preclude transplantation (eg lymphoma, leukaemia, myelodysplastic syndrome and others)
- Patients with poorly controlled diabetes mellitus (HbA1C \> 8%)
- Patients with renal insufficiency (creatinine \> 2.5).
- Patients with evidence of infectious disease as determined by e. above or other medical findings.
- Pregnant women (women capable of childbearing must have a negative pregnancy test).
- Patients with cognitive impairments.
- Other comorbid disease that would be expected to result in less than one year life expectancy
- Past malignancy or history of chemotherapy or radiation affecting the bone marrow.
- History of inflammatory or progressively fibrotic conditions: .e.g., rheumatoid arthritis, systemic lupus erythematosis, vasculitic disorders, idiopathic pulmonary fibrosis, retroperitoneal fibrosis
- Infection as evidenced by WBC count of \>15,000 and/or temperature more than 38C. Large area of cellulitis in the afflicted limb that in the opinion ofthe investigators would require the institution of antibiotics OR evidence of osteomyelitis corroborated by radiographic or scintigraphic examination
- Cardiovascular conditions:
- EF\<30%
- Acute ST elevation myocardial infarction (MI) within 1month;
- Transient ischemic attack or stroke within 1 month;
- Severe valvular disease
- CVA
- Patients with any history of organ transplants
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00677404
Start Date
January 1 2008
End Date
January 1 2010
Last Update
July 29 2011
Active Locations (2)
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1
Royan Institute
Tehran, Tehran Province, Iran, 1665659911
2
Tehran University of medical sciences, Vascular Surgery department, Sina Hospital
Tehran, Tehran Province, Iran