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Trial record 21 of 67 for:    stem cell peripheral arterial disease AND Occlusive

Cell Therapy for Peripheral Arterial Disease and Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03635970
Recruitment Status : Active, not recruiting
First Posted : August 17, 2018
Last Update Posted : August 31, 2018
Sponsor:
Collaborator:
Instituto Mexicano del Seguro Social
Information provided by (Responsible Party):
Hospital Regional de Alta Especialidad del Bajio

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.


Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Diabetes Mellitus Procedure: celular therapy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Treatment for peripheral arterial disease plus diabetes with 2 arms of study.
Masking: Single (Outcomes Assessor)
Masking Description: the evaluator of the treatment goals does not know the treatment that each patient received
Primary Purpose: Treatment
Official Title: Microvascular Effect After the Application of Cell Therapy With a Hematopoietic Stem Cell Concentrate in Patients With Peripheral Arterial Disease With Non-critical Ischemia and Diabetes
Actual Study Start Date : May 18, 2018
Actual Primary Completion Date : May 18, 2018
Estimated Study Completion Date : May 18, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: conventional treatment
receive the best conventional therapy
Procedure: celular therapy
application of cell therapy with a concentrate of hematopoietic progenitor cells or celular therapy

Active Comparator: experimental treatment
The best medical treatment possible plus celular therapy
Procedure: celular therapy
application of cell therapy with a concentrate of hematopoietic progenitor cells or celular therapy




Primary Outcome Measures :
  1. TcPO2 [ Time Frame: 180 days ]
    Change is being assessed, through the transcutaneous pressure of oxygen, after the application of the therapies



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03635970


Locations
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Mexico
Instituto Mexicano Del Seguro Social
León, Guanajuato, Mexico, 37660
Sponsors and Collaborators
Hospital Regional de Alta Especialidad del Bajio
Instituto Mexicano del Seguro Social
Investigators
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Study Director: B MURILLO, MD IMSS

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Responsible Party: Hospital Regional de Alta Especialidad del Bajio
ClinicalTrials.gov Identifier: NCT03635970     History of Changes
Other Study ID Numbers: CIBIUG-P14-2018
First Posted: August 17, 2018    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Diabetes Mellitus
Atherosclerosis
Arteriosclerosis