Application of Cell Regeneration Therapy With Mesenchymal Stem Cells From Adipose Tissue in Critical Chronic Ischemic Syndrome of Lower Limbs (CLI) in Nondiabetic Patients.

Critical Limb Ischemia Clinical Trial

Official title: Clinical Trial Phase I / II, Multicentre, Open, Randomized Study of the Use of Mesenchymal Stem Cells From Adipose Tissue (CeTMAd) as Cell Regeneration Therapy in Critical Chronic Ischemic Syndrome of Lower Limb in Nondiabetic Patients.

Status Completed

Clinical Trial Summary

Clinical trial phase I / II, prospective, multicenter, open, randomized, parallel-groups controlled by two levels of dose to assess the safety and feasibility of the infusion of mesenchymal stem cells from adipose tissue administered intra-arterially in nondiabetic patients with chronic ischemia of lower limbs (CLI) and no possibility of revascularization.

Clinical Trial Description

A prospective, multicenter, open, randomized, parallel-group controlled study for two levels of dose.

The study population will consist of 30 non-diabetic patients with critical chronic ischemia in at least one of the lower limbs (CLI) and without possibility of revascularization, from whom results can clinically be evaluable, of whom, 20 patients will be included in the experimental group (10 for each dose level) and 10 in the control group.

In each of the two dose levels to be used in the study, 15 patients will be included, who will be randomized to the experimental group or the control group according to a distribution 2:1 (2 patients in the experimental group and 1 in control group), thus at each dose level, we will have 10 patients in the experimental group (treated with mesenchymal cells of adipose tissue) and 5 patients in the control group (conventional treatment, including the use of prostaglandins per protocol).

Patients who are randomized to experimental treatment Group with CeTMAd may receive one of the following dose levels:

• 0.5x106 cells / kg of patient weight

• 1x106 cells / kg of patient weight

The recruitment will be done with escalating doses, starting at the lower dose. To switch to the higher dose will require a favorable opinion of the Ethics Committee of the H. Universitario Virgen Macarena to evaluate the clinical status of patients and therapeutic safety and study procedures.

Patients who are randomized to the treatment control group will continue with conventional treatment which they were performing at the time of inclusion in the study (including the use of prostaglandins as protocol).

STUDY OBJECTIVE: To evaluate the safety and feasibility of regenerative treatment with mesenchymal stem cells from adipose tissue (CeTMAd), administered intraarterial in nondiabetic patients with chronic critical ischemia of at least one lower limb without possibilities of revascularization or alternative therapies. We will analyze the complications from regenerative therapy and / or study procedures.

• Main objectives:

1. Security: It will be studied the possible complications due to the procedure in the first 24 hours of administration of CeTMAd, 1 month, 3 months, 6 months, 9 months and 12 months.

2. Efficiency: It will be studied the generation of new vessels (vasculogenesis) and enhancement of collateral circulation (angiogenesis / arteriogenesis).

• Secondary objectives:

It will be studied the evolution of ankle brachial index, transcutaneous oxygen pressure, degree of Rutherford-Becker, ulcer size, calf perimeter, the score of pain and intermittent claudication (walking test).

Duration of the clinical trial: From the infusion to the patient of the Mesenchymal Stem Cells from Adipose Tissue to the end of the monitoring, there will be 12 months. ;

Related Conditions & MeSH terms

• Critical Limb Ischemia
• Ischemia

• NCT number: NCT01745744
• Study type: Interventional
• Source: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
• Status: Completed
• Phase: Phase 2
• Start date: February 2011
• Completion date: July 2018