Cell Therapy for Peripheral Arterial Disease and Diabetes

NCT03635970 | Completed

• 1 other identifier: CIBIUG-P14-2018
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease; Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• TcPO2

  Change is being assessed, through the transcutaneous pressure of oxygen, after the application of the therapies

  180 days

Study Arms (2)

conventional treatment

PLACEBO COMPARATOR

receive the best conventional therapy

Procedure: celular therapy

experimental treatment

ACTIVE COMPARATOR

The best medical treatment possible plus celular therapy

Procedure: celular therapy

Interventions

celular therapy PROCEDURE

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

conventional treatment; experimental treatment

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with affiliation to the Mexican Institute of Social Security.
• Patients older than 35 years.
• Patients with Type 2 Diabetes Mellitus over 10 years of detection.
• Patients with Peripheral Arterial Disease with ABI between 0.6 and 0.9.
• Signature of informed consent.

You may not qualify if:

• Patients with a history of uncontrolled oncological disease in the last 5 years.
• Presence of Chronic Renal Insufficiency with a calculated creatinine clearance using a Cockcroft formula less than 15ml / min.
• Ulcer that defines diabetic foot or tissue necrosis that requires partial or total amputation of a limb.
• Serious active infectious process anywhere in the body.
• 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.

Sponsors & Collaborators

• Hospital Regional de Alta Especialidad del Bajio: lead
• Instituto Mexicano del Seguro Social: collaborator

Study Sites (1)

Instituto Mexicano Del Seguro Social

León, Guanajuato, 37660, Mexico

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• B MURILLO, MD

  IMSS

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: the evaluator of the treatment goals does not know the treatment that each patient received
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Treatment for peripheral arterial disease plus diabetes with 2 arms of study.

Study Record Dates

• First Submitted: July 6, 2018
• First Posted: August 17, 2018
• Study Start: May 18, 2018
• Primary Completion: May 18, 2018
• Study Completion: July 27, 2020
• Last Updated: August 31, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will become available in every time and after one year after its publication
• Access Criteria: Via email, the researchers can request information about study

Locations

ME (1)