Intramuscular Autologous Stem Cell Therapy for Patients With Chronic Limb Ischemia (CLI)

Phase 1

Lead Sponsor: KIMS Foundation and Research Center and Krishna Institute of Medical Sciences

Recruitment & Eligibility

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 <= 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 <=.

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 < 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

Primary Outcome Measures

Name	Time	Method
To measure the ulcer healing and improvement of walking distance through induction of vasculogenesis (Time Frame 6 months) <br/ ><br>Ulcer healing â?? measured by reduction in wound size and formation of scar tissue (Time Frame 6 months) <br/ ><br>Prevention of major amputation of the lower limb (Time Frame 6 Months) <br/ ><br>Number of adverse events as a measure of safety (Time Frame 1, 3 Months) <br/ ><br>Timepoint: 1, 3, 6 months

Secondary Outcome Measures

Name	Time	Method
Improvement in ABI, TcPO2, relief from rest pain and prevention of major amputation (Time Frame 6 months) <br/ ><br>Serious Adverse Events (Time Frame 1, 3 month) <br/ ><br>Improvement in Quality of life (Time Frame 6 months) <br/ ><br>Timepoint: 1, 3, 6 months