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Cell Therapy for Peripheral Arterial Disease and Diabetes

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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

Tracking Information
First Submitted Date  ICMJE July 6, 2018
First Posted Date  ICMJE August 17, 2018
Last Update Posted Date August 31, 2018
Actual Study Start Date  ICMJE May 18, 2018
Actual Primary Completion Date May 18, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 15, 2018)
TcPO2 [ Time Frame: 180 days ]
Change is being assessed, through the transcutaneous pressure of oxygen, after the application of the therapies
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cell Therapy for Peripheral Arterial Disease and Diabetes
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Peripheral Arterial Disease
  • Diabetes Mellitus
Intervention  ICMJE Procedure: celular therapy
application of cell therapy with a concentrate of hematopoietic progenitor cells or celular therapy
Study Arms  ICMJE
  • Placebo Comparator: conventional treatment
    receive the best conventional therapy
    Intervention: Procedure: celular therapy
  • Active Comparator: experimental treatment
    The best medical treatment possible plus celular therapy
    Intervention: Procedure: celular therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 15, 2018)
24
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 18, 2019
Actual Primary Completion Date May 18, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03635970
Other Study ID Numbers  ICMJE CIBIUG-P14-2018
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Hospital Regional de Alta Especialidad del Bajio
Study Sponsor  ICMJE Hospital Regional de Alta Especialidad del Bajio
Collaborators  ICMJE Instituto Mexicano del Seguro Social
Investigators  ICMJE
Study Director: B MURILLO, MD IMSS
PRS Account Hospital Regional de Alta Especialidad del Bajio
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP