Cell Therapy With Mesenchymal Stem Cell in Ischemic Limb Disease

Taiwan Bio Therapeutics Inc.18 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Critical Limb Ischemia

Interventions

Allogenic MSCDRUG

Hypoxia-cultured human bone marrow derived mesenchymal stem cells

Normal salineDRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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%

Locations (1)

Taipei Veterans General Hospital

Taipei, Taiwan

Outcomes

Primary Outcomes

Adverse events

Number of adverse events reported

Time frame: 6 months

Secondary Outcomes

Efficacy-The Wong Baker FACES® pain rating scale

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

Time frame: 6 months

Efficacy-Transcutaneous oxygen pressure(TcPO2)

The Transcutaneous oxygen pressure (TcPO2) on foot of subjects receiving cell injection compared to placebo

Time frame: 6 months

Efficacy-walking distance (TWD)

Total walking distance (TWD) on a standardized treadmill test compared to placebo

Time frame: 6 months

Efficacy-Ankle Brachial Pressure Index (ABPI)

The Ankle Brachial Pressure Index (ABPI) in the lower limb of subjects receiving cell injection compared to placebo

Time frame: 6 months

Data from ClinicalTrials.gov

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