Trial | NCT02336646  Report issue

Official Title

Cell Therapy With Mesenchymal Stem Cell in Ischemic Limb Disease

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    18
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 Started
May 01
2015
Primary Completion
Apr 27
2018
Study Completion
Dec 20
2018
Last Update
Aug 25
2021

Drug Allogenic MSC

Hypoxia-cultured human bone marrow derived mesenchymal stem cells

  • Other names: Biochymal

Drug Normal saline

Low Dose Allogenic MSC Experimental

Low dose allogenic mesenchymal stem cells with IM injection

High Dose Allogenic MSC Experimental

High dose allogenic mesenchymal stem cells with IM injection

Placebo Placebo Comparator

normal saline with Intramuscular injection

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%
No Results Posted