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Umbilical Cord Mesenchymal Stem Cells Injection for Diabetic Foot

NCT ID: NCT01216865

Last Updated: 2010-10-13

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-07-31

Brief Summary

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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

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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).

Conditions

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Diabetic Foot Critical Limb Ischemia Mesenchymal Stem Cells Umbilical Cord

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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umbilical cord mesenchymal stem cells

Multiple intra muscular injection of mesenchymal stem cells derived from human umbilical cord.

Group Type EXPERIMENTAL

umbilical cord mesenchymal stem cells

Intervention Type BIOLOGICAL

5\*10/7 per ischemic limb

Standard Therapy

Any therapy for diabetic foot which is routinely practiced and accepted in China

Group Type ACTIVE_COMPARATOR

Standard Therapy

Intervention Type DRUG

Any thing directed to improve blood perfusion in the limb example.Heparin,Antiplatelet agents etc

Interventions

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umbilical cord mesenchymal stem cells

5\*10/7 per ischemic limb

Intervention Type BIOLOGICAL

Standard Therapy

Any thing directed to improve blood perfusion in the limb example.Heparin,Antiplatelet agents etc

Intervention Type DRUG

Other Intervention Names

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mesenchymal stem cells Drug therapy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qingdao University

OTHER

Sponsor Role lead

Responsible Party

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Stem Cell Research Center of Medical School Hospital of Qingdao University

Principal Investigators

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Yangang Wang, MD Phd

Role: STUDY_DIRECTOR

The Affiliated Hospital of Qingdao University

Locations

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Stem Cell Research Center of Medical School Hospital of Qingdao University

Qingdao, Shandong, China

Site Status

Countries

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China

Central Contacts

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Jianxia Hu, MD

Role: CONTACT

[email protected]
86-0532-82911676

Hong Gao, MS

Role: CONTACT

[email protected]
86-0532-82911676

Facility Contacts

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Jianxia Hu, MD

Role: primary

[email protected]
86-0532-82911676

Hong Gao, MS

Role: backup

[email protected]
86-0532-82911676

Other Identifiers

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MSCDF001

Identifier Type: -

Identifier Source: org_study_id