Diabetes Mellitus Clinical Trial
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
Verified date | August 2020 |
Source | Hospital Regional de Alta Especialidad del Bajio |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 24 |
Est. completion date | July 27, 2020 |
Est. primary completion date | May 18, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 35 Years to 80 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Mexico | Instituto Mexicano Del Seguro Social | León | Guanajuato |
Lead Sponsor | Collaborator |
---|---|
Hospital Regional de Alta Especialidad del Bajio | Instituto Mexicano del Seguro Social |
Mexico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | TcPO2 | Change is being assessed, through the transcutaneous pressure of oxygen, after the application of the therapies | 180 days |
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