Lower Extremity IschemiaPhase 2NCT00753025
Autologous Bone Marrow For Lower Extremity Ischemia Treating
A Phase 2 study testing Bone marrow aspiration, injection of cells, Bone marrow aspiration , injection of isolated CD 133+ cells and Bone marrow aspiration, injection of saline in people with Lower Extremity Ischemia, run by Clinical Center of Cellular Technologies, Russia.
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 Read more about this study
- Who is it for?
- Ages 39 to 70 years, men only
- Conditions the study is for
- Lower Extremity Ischemia
- What is being tested?
- Bone marrow aspiration, injection of cells, Bone marrow aspiration , injection of isolated CD 133+ cells and Bone marrow aspiration, injection of saline
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Oct 2006to Feb 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 39 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- an obliterating lower extremity atherosclerosis IIB a stage (on Fontaine classification)
- a painless walking distance of 10-50 m
- pulse absence on аа. 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
Who cannot join
- 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
Show all 9Show fewer
- a virus hepatitis
- oncologic diseases
- chemotherapy in the anamnesis
About this study
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
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
Read the detailed 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.
- Conditions
- Lower Extremity Ischemia
- Being tested
- Bone marrow aspiration, injection of cells, Bone marrow aspiration , injection of isolated CD 133+ cells, Bone marrow aspiration, injection of saline
- Keywords
- lower extremity ischemia, Bone marrow, Progenitor cells, Neoangiogenesis
- Medical subject headings
- Neovascularization, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone marrow aspiration, injection of cellsProcedure or surgery
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+ cellsProcedure or surgery
arm "CD133" receives injection of isolated CD 133+ cells
Bone marrow aspiration, injection of salineProcedure or surgery
arm "placebo" receives injection of saline
| Study group | Role | What they receive |
|---|---|---|
| CD133 | Experimental | Not described Receives: Procedure: Bone marrow aspiration , injection of isolated CD 133+ cells |
| TNC | Experimental | Not described Receives: Procedure: Bone marrow aspiration, injection of cells |
| Placebo | Placebo comparator | Not described Receives: Procedure: Bone marrow aspiration, injection of saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increasing of painless walking distance
Measured: Within the first 30 days, 6 months and 12 months after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2008 (estimated)
- Study startOct 2006
- Primary completionJun 2007
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Extremity IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Center of Cellular Technologies, Russia
- Sponsor type
- Other government
- Collaborators
- Samara State Medical University, Regional hospital of Samara
- Investigators
- Olga Tyumina, PhD, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00753025
- Sponsor's protocol ID
- CCCT001
- Status last verified
- Sep 2008
- First submitted
- 9 Sep 2008
- Last updated
- 16 Sep 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00753025
- Acronym / sponsor ID
- CCCT001
- Conditions
- Lower Extremity Ischemia
- Keywords
- lower extremity ischemia, Bone marrow, Progenitor cells, Neoangiogenesis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Clinical Center of Cellular Technologies, RussiaOther government
- Collaborators
- Samara State Medical University, Regional hospital of Samara
- Study start
- Oct 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 16 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CD133 | Experimental | Procedure: Bone marrow aspiration , injection of isolated CD 133+ cells |
| TNC | Experimental | Procedure: Bone marrow aspiration, injection of cells |
| Placebo | Placebo comparator | Procedure: Bone marrow aspiration, injection of saline |
Who may qualify
- Ages
- 39 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- an obliterating lower extremity atherosclerosis IIB a stage (on Fontaine classification)
- a painless walking distance of 10-50 m
- pulse absence on аа. 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone marrow aspiration, injection of cellsBone marrow is aspirated at patients in all arms. Arm "TNC" receives injection of total nucleated cells into ischemic muscle | Procedure or surgery | TNC |
| Bone marrow aspiration , injection of isolated CD 133+ cellsarm "CD133" receives injection of isolated CD 133+ cells | Procedure or surgery | CD133 |
| Bone marrow aspiration, injection of salinearm "placebo" receives injection of saline | Procedure or surgery | Placebo |
Primary outcome
Increasing of painless walking distance
Time frame: Within the first 30 days, 6 months and 12 months after injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olga Tyumina, PhD study director
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bone marrow aspiration, injection of cells, Bone marrow aspiration , injection of isolated CD 133+ cells and Bone marrow aspiration, injection of saline in people with Lower Extremity Ischemia, run by Clinical Center of Cellular Technologies, Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increasing of painless walking distance (time frame: Within the first 30 days, 6 months and 12 months after injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2008; AzTrials last refreshed its copy on 2 Nov 2026.