Autologous Transplantation of Bone Marrow Mesenchymal Stem Cells on Diabetic Foot

Objective:

To study the therapeutic effect and the safety of transplantation of autologous bone marrow mesenchymal stem cells following amplification on diabetic foot.

Methods:

Type 2 diabetic patients with diabetic foot were enrolled and randomized to either the transplanted group or the control group. Patients in both groups received the same conventional treatment. 20 ml bone marrow from each transplanted patient was collected, and the mesenchymal stem cells were separated by density gradient centrifugation and then cultured in the medium with autologous serum (from each patient in the transplant group, about 200 ml of whole blood was drained into blood bags, clotted and then centrifuged. Afterwards, the serum was collected and filtered through a 0.2-μm membrane.)

After culture in vitro, mesenchymal stem cells go through safety evaluation which includes 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 safe cells are harvested and transplanted by multiple intramuscular and hypodermic injections into the impaired lower limbs. Follow-up index include: efficacy (pain,healing rate, ulcer  lower limb amputation rate and ,ankle-brachial index,magnetic resonance angiography,electromyogram) and safety (immunological rejection, infection of the injection site, and tumour generation).