Cell Therapy With Mesenchymal Stem Cell in Ischemic Limb Disease
- Registration Number
- NCT02336646
- Lead Sponsor
- Taiwan Bio Therapeutics Inc.
- Brief 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.
- Detailed Description
Ischemic limb disease remains one of the major causes of morbidity and mortality in the industrialized world despite the development of several new therapeutic modalities. Based on experimental data demonstrating that infusion or injection of stem/progenitor cells enhances blood flow in models of cardiovascular diseases, clinical trials were initiated in 2001 to treat patients with critical limb ischemia or cardiac ischemia with circulating blood or bone marrow-derived cells. Despite all promises, pending uncertainties and practical limitations attenuate the therapeutic use of stem/progenitor cells for ischemic limb disease. The main theme and method in the current program project, based on expertise, track record, and preliminary results of PI's laboratory, is to focus on clinical studies of using allogenic mesenchymal stem cells (MSCs), expanded under hypoxic conditions (1% O2), in treating ischemic limbs. This project is an integrated and coordinated effort aimed to overcome the regulation of cell product, and the barriers of preclinical and clinical studies. For the purposes, we have specially set up the core laboratory for stem/progenitor cells production and quality control in Cell Therapy Clean Room on the 9th floor of Medical Science Technology Building in Taipei Veterans General Hospital. We have also completed the preclinical studies in using allogenic hypoxic mouse MSCs in treating limb ischemia. In the current project, 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 in three years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
- 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
- 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%
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Low Dose Allogenic MSC Allogenic MSC Low dose allogenic mesenchymal stem cells with IM injection High Dose Allogenic MSC Allogenic MSC High dose allogenic mesenchymal stem cells with IM injection Placebo Normal saline normal saline with Intramuscular injection
- Primary Outcome Measures
Name Time Method Adverse events 6 months Number of adverse events reported
- Secondary Outcome Measures
Name Time Method Efficacy-The Wong Baker FACES® pain rating scale 6 months The Wong Baker FACES® pain rating scale, for evaluation of ischemic pain in the diseased lower limb of subjects receiving cell injection compared to placebo
Efficacy-Transcutaneous oxygen pressure(TcPO2) 6 months The Transcutaneous oxygen pressure (TcPO2) on foot of subjects receiving cell injection compared to placebo
Efficacy-walking distance (TWD) 6 months Total walking distance (TWD) on a standardized treadmill test compared to placebo
Efficacy-Ankle Brachial Pressure Index (ABPI) 6 months The Ankle Brachial Pressure Index (ABPI) in the lower limb of subjects receiving cell injection compared to placebo
Trial Locations
- Locations (1)
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan