NCT01216865

Umbilical Cord Mesenchymal Stem Cells Injection for Diabetic Foot

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Qingdao University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-01-01
• Primary completion: 2012-12-01
• Completion: 2013-07-01
• First posted: 2010-10-07
• Last updated: 2010-10-13

Locations

1 site across 1 country: China