Cell Therapy for Peripheral Arterial Disease and Diabetes

NCT ID: NCT03635970

Last Updated: 2020-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-18
• Study Completion Date: 2020-07-27

Brief Summary

This is a randomized controlled trial with blinding (for the observer who evaluates treatment goals).

With two groups to study. A group of patients with conventional therapy for the treatment of PAD (Platelet antiaggregant, statin, cilostazol in case of claudication) and the other group of patients with conventional therapy for treatment of PAD plus cell therapy with objective to evaluate the microvascular effect after the application of cell therapy with a hematopoietic stem cell concentrate in patients with PAD with non-critical ischemia and Diabetes. Perform evaluations of the microcirculation by means of TcPO2 at 30, 60, 90 and 180 days after the experimental maneuver (cell therapy) and conventional therapy.

Detailed Description

INTRODUCTION: Peripheral arterial disease (PAD) is defined as arterial occlusion of the lower extremities. Based on epidemiological studies using the Ankle-Brachial Index (ABI), the prevalence of PAD (defined as an ABI <0.9) in diabetic patients ranges from 20% to 30%. Diabetic patients with PAD have a higher mortality and death rate at a younger age than patients without diabetes. The appropriate medical treatment for EAP in patients with diabetes is based on the control of cardiovascular risk factors. Revascularization is indicated in particular situations in PAD in the context of critical chronic ischemia (ABI <0.6), however, anatomical factors, operative risk, technical difficulties or patient preferences may limit its use in patients with PAD and diabetes. Therapeutic angiogenesis is an experimental approach to restore perfusion and cell therapy can provide a continuous source of growth factors and structural elements for therapeutic angiogenesis. The transcutaneous oxygen pressure (TcPO2) is defined as a microvascular evaluation system. The microvascular effect of cell therapy at an earlier stage of PAD has not been analyzed as non-critical ischemia in patients with diabetes.

OBJECTIVE: To evaluate the microvascular effect after the application of cell therapy with a concentrate of hematopoietic stem cell in patients with PAD with non-critical ischemia and Diabetes.

MATERIAL AND METHODS: Randomized controlled clinical trial with blinding (for the observer who evaluates treatment goals). With two groups for your study. A group of patients with conventional therapy for the treatment of PAD (Platelet antiaggregant, statin, cilostazol in case of claudication) and the other group of patients with conventional therapy for treatment of PAD plus cell therapy, to be carried out in patients entitled to the Mexican Institute of the Social Security of the Guanajuato Delegation, with diagnosis of Diabetes Mellitus type 2 of more than 10 years of detection and with diagnosis of peripheral arterial disease with an ABI between 0.6 and 0.9 that agree to participate in the study. Cell therapy will consist of hematopoietic progenitor cells identified as a fraction of cells identified by flow cytometry as CD34 + obtained by peripheral blood harvesting procedure, prior mobilization process with filgrastim.

Conditions

Peripheral Arterial Disease; Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

conventional treatment

receive the best conventional therapy

Group Type: PLACEBO_COMPARATOR

celular therapy

Intervention Type: PROCEDURE

application of cell therapy with a concentrate of hematopoietic progenitor cells or celular therapy

experimental treatment

The best medical treatment possible plus celular therapy

Group Type: ACTIVE_COMPARATOR

celular therapy

Intervention Type: PROCEDURE

application of cell therapy with a concentrate of hematopoietic progenitor cells or celular therapy

Interventions

celular therapy

application of cell therapy with a concentrate of hematopoietic progenitor cells or celular therapy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Patients with affiliation to the Mexican Institute of Social Security.

2. Patients older than 35 years.

3. Patients with Type 2 Diabetes Mellitus over 10 years of detection.

4. Patients with Peripheral Arterial Disease with ABI between 0.6 and 0.9.

5. Signature of informed consent.

Exclusion Criteria

1. Patients with a history of uncontrolled oncological disease in the last 5 years.

2. Presence of Chronic Renal Insufficiency with a calculated creatinine clearance using a Cockcroft formula less than 15ml / min.

3. Ulcer that defines diabetic foot or tissue necrosis that requires partial or total amputation of a limb.

4. Serious active infectious process anywhere in the body.

5. Have restrictions with the use of filgrastim such as treatment with lithium, chemotherapy or radiotherapy, as well as a history of autoimmune thrombocytopenia, vasculitis, previous cardiovascular disease, Sweet's syndrome or Steven-Johnson syndrome.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto Mexicano del Seguro Social

OTHER_GOV

Sponsor Role: collaborator

Hospital Regional de Alta Especialidad del Bajio

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

B MURILLO, MD

Role: STUDY_DIRECTOR

IMSS

Locations

Instituto Mexicano Del Seguro Social

León, Guanajuato, Mexico

Countries

Mexico

Other Identifiers

CIBIUG-P14-2018

Identifier Type: -

Identifier Source: org_study_id