Health Condition 1: null- Critical Limb Ischemia
Conditions
Interventions
Intervention1: Stem Cell Therapy: Intramuscular injection of 60 - 80 million autologous hematopoietic stem cells in the diseased lower limb at day 0 and 30
Control Intervention1: Standard Treatment: I
Sponsors
KIMS Foundation and Research Center and Krishna Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 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 6. Patients with neuropathy symptoms with DNS score of >= 1.5 and/or DNE score >= 5.0. 7. Patients with VascuQOL questionnaire score of
Exclusion criteria
Exclusion criteria: 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 = 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To measure the ulcer healing and improvement of walking distance through induction of vasculogenesis (Time Frame 6 months) Ulcer healing â?? measured by reduction in wound size and formation of scar tissue (Time Frame 6 months) Prevention of major amputation of the lower limb (Time Frame 6 Months) Number of adverse events as a measure of safety (Time Frame 1, 3 Months) Timepoint: 1, 3, 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in ABI, TcPO2, relief from rest pain and prevention of major amputation (Time Frame 6 months) Serious Adverse Events (Time Frame 1, 3 month) Improvement in Quality of life (Time Frame 6 months) Timepoint: 1, 3, 6 months | — |
Countries
India
Contacts
Public ContactDr GVPraveen Kumar
Krishna Institute of Medical Sciences/KIMS Foundation and Research Center
Outcome results
None listed