Autologous Bone Marrow For Lower Extremity Ischemia Treating

Lower Extremity Ischemia Clinical Trial

Official title:

Randomized Double Blind Placebo-Controlled Research Of Treatment Efficiency For Patients With Lower Extremity Arteriosclerosis Obliterans By Autologous Transplantation Of Bone Marrow Progenitor Cells

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00753025
• Other study ID #: CCCT001
• Status: Completed
• Phase: Phase 2
• First received: September 9, 2008
• Last updated: September 15, 2008
• Start date: October 2006
• Est. completion date: February 2008

Study information

• Verified date: September 2008
• Source: Clinical Center of Cellular Technologies, Russia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether autologous bone marrow derived cells and isolated CD133+ fraction are effective in the treatment limb ischemia

Description:

The number of patients with low limb obliterating atherosclerosis steadily grows and compounds more than 20-25 % from all kinds of a cardiovascular pathology. At conservation of this tendency to 2020 the amputation percentage executed due to vessel diseases, can reach 45 %. Hemodynamics improvement in an extremity by surgery is possible at 40 - 70 % of patients even with the widespread and plural lesion of arteries, but results are not always satisfactory. The most actual is the problem of angiosurgical help to patients with distal forms of arterial occlusions, due to the difficulty or impossibility performing reconstructive interventions. In these cases the operations of an indirect revascularization referred on stimulation of a collateral blood flow are carried out. However, despite the reached successes, in some cases results of such interventions do not give desirable effect, search of new methods of treatment therefore is necessary. To date the most perspective methods of neoangiogenesis stimulation are a cellular therapy and gene-engineering technologies. Experimental researches on a model of local limb ischemia showed possibility of use of various cells for neoangiogenesis stimulation. A number of clinical researches at patients with obliterating limb diseases has shown efficacy of cellular therapy even at a critical ischemia. However randomized, the placebo-controlled researches based on principles of evidence based medicine while it is not enough for the convincing conclusions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: February 2008
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 39 Years to 70 Years

Eligibility

Inclusion Criteria:

• an obliterating lower extremity atherosclerosis IIB a stage (on Fontaine classification)

• a painless walking distance of 10-50 m

• pulse absence on ??. dorsalis pedis, tibialis posterior, poplitea

• absence of a ischemia in a rest and necrotic changes

• mainly distal form of disease (a lesion of a superficial femoral artery, a popliteal artery, anticnemion arteries) according to an angiography that testifies to impossibility of reconstructive operation performance

• patients after a lumbar sympathectomy and a tibial bone osteoperforations executed previously

• heavy smokers

Exclusion Criteria:

• insulin depended diabetes

• myocardial infarction or a stroke within last year

• an idiopathic hypertensia III stage

• anaemia and other diseases of blood

• decompensation of the chronic diseases which are contraindications to any surgical operation

• HIV infection

• a virus hepatitis

• oncologic diseases

• chemotherapy in the anamnesis

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arteriosclerosis Obliterans
• Ischemia
• Lower Extremity Ischemia

Intervention

Procedure:
• Bone marrow aspiration, injection of cells
Bone marrow is aspirated at patients in all arms. Arm "TNC" receives injection of total nucleated cells into ischemic muscle
• Bone marrow aspiration , injection of isolated CD 133+ cells
arm "CD133" receives injection of isolated CD 133+ cells
• Bone marrow aspiration, injection of saline
arm "placebo" receives injection of saline

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Clinical Center of Cellular Technologies, Russia	Regional hospital of Samara, State medical University of Samara

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increasing of painless walking distance		Within the first 30 days, 6 months and 12 months after injection	No