Cell Therapy With Mesenchymal Stem Cell in Ischemic Limb Disease

• Status: Completed
• Trial end date: 2018-12-20
• Target enrollment: 0
• Participant gender: All

Summary

Bone marrow MSCs will be isolated from allogenic donors, expanded under hypoxic conditions using medium containing no serum or animal-derived reagents, and applies for Phase Ⅰ/Ⅱ study in treating 18 recipients with ischemic limb diseases.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taiwan Bio Therapeutics Co., Ltd.

Criteria

Inclusion Criteria:

• Fontaine stage > II, total walking distance < 100 m, stair < 1 floor, or ulcer / necrosis

• Established critical limb ischemia, clinically and hemodynamically confirmed as per Rutherford- Ⅱ-4, Ⅲ-5, or Ⅲ-6; Patients having Infra-inguinal arterial occlusive disease with rest pain or ischemic ulcer/necrosis, who are not eligible for or have failed traditional revascularization treatment

• Ankle Brachial Pressure Index (ABPI) ≤ 0.8，ankle pressure ≤ 70 mm Hg, or TcPO2 ≤ 70 mmHg in the foot

• No response to medication (aspirin and cilostazol)

• Normal liver and renal function

• On regular medication for hypertension if any

Exclusion Criteria:

• The above mentioned patients combined with infection or systemic septicemia. (ps, patients with poor control of diabetes, hypertension and hyperlipidemia will also be excluded

• Patient with Immunocompromised or immunosuppressed

• Type I Diabetes

• Patients having stroke or myocardial infarction within last 3 months

• Hb% < 10 gm%, Serum Creatinine ≥ 2mg%, Serum Total Bilirubin ≥2mg%, HbA1c > 8%