Cell Therapy With Mesenchymal Stem Cell in Ischemic Limb Disease

Critical Limb Ischemia Clinical Trial

Official title:

Cell Therapy With Mesenchymal Stem Cell in Ischemic Limb Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02336646
• Other study ID #: 2012-02-070B
• Status: Completed
• Phase: Phase 1
• Start date: May 1, 2015
• Est. completion date: December 20, 2018

Study information

• Verified date: November 2015
• Source: Taiwan Bio Therapeutics Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 20, 2018
• Est. primary completion date: April 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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- ?-4, ?-5, or ?-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%

Related Conditions & MeSH terms

• Critical Limb Ischemia
• Ischemia

Intervention

Drug:
• Allogenic MSC
Hypoxia-cultured human bone marrow derived mesenchymal stem cells
• Normal saline

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taiwan Bio Therapeutics Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events	Number of adverse events reported	6 months
Secondary	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	6 months
Secondary	Efficacy-Transcutaneous oxygen pressure(TcPO2)	The Transcutaneous oxygen pressure (TcPO2) on foot of subjects receiving cell injection compared to placebo	6 months
Secondary	Efficacy-walking distance (TWD)	Total walking distance (TWD) on a standardized treadmill test compared to placebo	6 months
Secondary	Efficacy-Ankle Brachial Pressure Index (ABPI)	The Ankle Brachial Pressure Index (ABPI) in the lower limb of subjects receiving cell injection compared to placebo	6 months