Autologous bone marrow derived progenitor cell therapy in critical limb ischemia (CLI) and foot ulcer in diabetes

KIMS Foundation and Research Center and Krishna Institute of Medical Sciences0 个研究点目标入组 48 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1. Patients aged between 35 â?? 75 years with chronic critical limb ischemia with Rutherford Category IV & V and Fontaine Scale IV.
•2. Patients failed basic conservative and standard revascularization treatment (Surgical/Endovascular)
•3. Patients with diagnosis of thromboangitis obliterans.
•4. Major amputation recommended due to life threatening PAD.
•5. ABI <= 0.5 or TcPO2 <= 40mm Hg or ankle systolic pressure <= 60mm Hg
•6. Patients with neuropathy symptoms with DNS score of >= 1.5 and/or DNE score >= 5.0.
•7. Patients with VascuQOL questionnaire score of <=.

•1. Advanced CLI (Rutherford Category VI), characterized by extensive tissue loss or gangrene.
•2. CLI patient requiring amputation proximal to trans-metatarsal level.
•3. Subjects with severe COPD
•4. Heart angioplasty or CABG within 3 months prior to enrollment.
•5. Ischemic wounds with uncontrolled infectious symptoms
•6. Subjects with immunodeficient states or receiving immunosuppressive drugs.
•7. Hb < 8.5 gm%; serum creatinine >= 2.0 mg%; serum total bilirubin >= 2.0 mg%; HbAlc > 8.0%
•8. Renal insufficiency or failure
•9. Hepatic dysfunction
•10. Hematologic or malignant disease
•11. History of bleeding disorder and/or platelet count <100,000/ml
•12. Not fit for anesthesia
•13. Patient who do not give consent
•14. Patient on ventilatory support
•15. Continued abuse of alcohol or other drugs
•16. Hepatitis B , HIV or HCV positive subjects
•17. Unable to give consent
•18. Psychiatric disorder/mentally unstable

发起方

KIMS Foundation and Research Center and Krishna Institute of Medical Sciences