Clinical trial NCT01216865: Umbilical Cord Mesenchymal Stem Cells Injection for Diabetic Foot
Official title: Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cells Injection for Diabetic Foot
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Diabetic Foot
Critical Limb Ischemia
Mesenchymal Stem Cells
Umbilical Cord
Keywords: Diabetic foot
critical limb ischemia
mesenchymal stem cells
umbilical cord
Lead sponsor: Qingdao University
Sponsor class: OTHER
First posted: 2010-10-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether umbilical cord Mesenchymal Stem Cells of treatment for diabetic foot is safe and effective in the management of diabetic foot ischemia, the therapeutic effect of stem cells is caused by improving blood circulation in ischemic limb which would in turn promote ulcer healing, prevent amputation of limb and relieve the Sevier pain of ischemia.

Detailed description: Type 2 diabetic patients with diabetic foot were enrolled and randomized to either transplanted group or control group. Patients in transplanted group received the stem cells treatment,Patients in control group received the standard treatment. After culture in vitro, umbilical cord mesenchymal stem cells should go through safety evaluation which include culture and check of pathogenic microorganisms (bacteria, mycoplasma, chlamydia, eumycete and viruses) of the cells medium and karyotype analysis of the mesenchymal stem cells. Only the safe cells were harvested and transplanted by multiple intramuscular injections into the impaired lower limbs. Follow-up index include: efficacy (pain,ulcer healing rate, lower limb amputation rate and ,ankle-brachial index,magnetic resonance angiography,electromyogram) and safety (infection of the injection site, fever, and tumour generation).

Eligibility criteria: Inclusion Criteria:

* Diabetes mellitus Type 2
* Age 18 - 75 years
* Subject has an Ankle-brachial index \< 0.9
* Subject has had previous conservative treatment which resulted in little or no improvement
* Subject has had no stem cell treatment within the past 6 months
* 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
* Life expectancy more than 2 years
* Negative pregnancy test when applicable

Exclusion Criteria:

* Diabetic retinopathy
* History of neoplasm or hematological disease
* Uncontrolled high blood pressure (\>180/110)
* Severe cardiac insufficiency (New York Heart Association \[NYHA\] IV) or ejection fraction\<30%
* Malignant ventricular arrythmia
* Deep venous thrombosis during the last 3 months
* Active bacterial infection
* Body mass index \> 35 Kg/m2
* Stroke or myocardial infarction during the last 3 months

Primary outcomes:
measure: Angiographic evaluation of angiogenesis at ischemic limb
timeFrame: 6 months
Secondary outcomes:
measure: Pain
timeFrame: 3 months
measure: Ankle-Brachial pressure index
timeFrame: 3 months
measure: Wound healing (wound size, wound stage)
timeFrame: 3 months
measure: Walking distance
timeFrame: 3 months
measure: Rate and extent of amputations
timeFrame: 6 months
Other outcomes:
Locations:
city: Qingdao
country: China
facility: Stem Cell Research Center of Medical School Hospital of Qingdao University
state: Shandong
Study officials:
affiliation: The Affiliated Hospital of Qingdao University
name: Yangang Wang, MD Phd
role: STUDY_DIRECTOR
References: