Umbilical Cord Mesenchymal Stem Cells Injection for Diabetic Foot

Diabetic Foot Clinical Trial

Official title:

Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cells Injection for Diabetic Foot

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01216865
• Other study ID #: MSCDF001
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: October 6, 2010
• Last updated: October 12, 2010
• Start date: January 2011
• Est. completion date: July 2013

Study information

• Verified date: January 2009
• Source: Qingdao University
• Contact: Jianxia Hu, MD
• Phone: 86-0532-82911676
• Email: qdyxyhjx[@]126.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: July 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Limb Ischemia
• Diabetic Foot
• Mesenchymal Stem Cells
• Umbilical Cord

Intervention

Biological:
• umbilical cord mesenchymal stem cells
5*10/7 per ischemic limb

Drug:
• Standard Therapy
Any thing directed to improve blood perfusion in the limb example.Heparin,Antiplatelet agents etc

Locations

Country	Name	City	State
China	Stem Cell Research Center of Medical School Hospital of Qingdao University	Qingdao	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qingdao University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Angiographic evaluation of angiogenesis at ischemic limb		6 months	No
Secondary	Pain		3 months	No
Secondary	Ankle-Brachial pressure index		3 months	No
Secondary	Wound healing (wound size, wound stage)		3 months	No
Secondary	Walking distance		3 months	No
Secondary	Rate and extent of amputations		6 months	No