Autologous Transplantation of BM-ECs With Platelet-Rich Plasma Extract for the Treatment of Critical Limb Ischemia
NCT ID: NCT02993809
Last Updated: 2016-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
40 participants
INTERVENTIONAL
2018-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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BM-ECs and PRPE
Multipoint of intramuscular injections into ischemic limbs.Injections composed of bone marrow derived endothelial cells (BM-ECs) and platelet-rich plasma extract (PRPE).
BM-ECs and PRPE
BM-ECs
Intramuscular injection of bone marrow derived endothelial cells only.
BM-ECs
Interventions
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BM-ECs and PRPE
BM-ECs
Eligibility Criteria
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Inclusion Criteria
1. 18 Years to 80 Years (Adult, Senior);
2. Have ability to understand and comply with the study requirements, and provide the written informed consent prior to any procedures ;
3. Patient meets at least one of the following diagnostic criteria for the index limb:
1. ABI\<0.7mmHg
2. TcpO2 \<40 mm Hg
3. Or, nonhealing ulcer due to local arterial compromise with no opportunity for revascularization;
4. Have no improvement after conservative treatment and are not suitable for surgical bypass surgery because no outflow tract of diseased vessel can be found by imaging;
5. Despite having good outflow artery, but the elderly and frail patients can also not tolerate revascularization or interventional surgery;
6. Unlikelihood of major amputation of the leg during the next 12 months;
7. Expected life span more than 2 years.
Exclusion Criteria
2. Diabetics with poorly controlled blood glucose levels (defined as HbA1c\>7% and/or proliferative retinopathy);
3. Patients with decompensated cardiac, renal or liver disease;
4. Patients with confirmed malignant tumor;
5. Subjects are with serious heart, liver, kidney and lung failure or under poor general condition that are inability to undergo bone marrow harvesting and transplantation;
6. Known or suspected disease of the immune system or osteomyelitis;
7. Inability to sign informed consent form and to comply with the schedule of the study;
8. There has reason to suspect that the patient is forced to join the study;
9. Any other condition, in the opinion of the investigator, would render the patient unsuitable for the study.
18 Years
80 Years
ALL
No
Sponsors
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South China Research Center for Stem Cell and Regenerative Medicine
OTHER
Responsible Party
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Central Contacts
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Other Identifiers
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BMEC-PRPE
Identifier Type: -
Identifier Source: org_study_id