Autologous BMMNC Combined With HA Therapy for PAOD (NCT03214887) | Clinical Trial Compass
WithdrawnPhase 1/2
Autologous BMMNC Combined With HA Therapy for PAOD
Stopped: Incomplete enrollment process
Taiwan0Started 2017-01-17
Plain-language summary
The purpose of this study is to evaluate the safety and efficacy of hyaluronan combined with autologous bone marrow mononuclear cells for the treatment of critical PAOD patients.
Who can participate
Age range20 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient age ≥ 20
* Patients with severe PAOD and diagnosed with Rutherford category 3, 4, or 5
* Contraindication to angioplasty or bypass surgery, or post-angioplasty or bypass surgery for once but with limited or no effect.
* Patient without hypertension or hypertensive patient with adequate-controlled blood pressure.
* With signed informed consent
Exclusion Criteria:
* Patient undergone any organ transplantation
* Inability to undergo bone marrow aspiration
* Pregnant woman
* Life expectancy \< 1 year
* Cognitive impairment
* Active malignancy in 5 years prior to treatment
* Bleeding diathesis or pulmonary embolism
* Patient with active major cardiovascular diseases such as unstable angina, arrhythmia, heart failure, impaired cardiac function (ejection fraction \< 45%), or stroke
* Estimated Glomerular Filtration Rate (eGFR) \< 30
* Glutamic oxaloacetic transaminase (GOT) and glutamic pyruvic transaminase (GPT) values higher than 80 U/L
* Patient with severe diabetes mellitus (HbA1C \> 8%)
* Patient with alcohol addiction
* Patient with drug abuse
* Patient with infections or skin disease on the ischemic leg.
* Allergic to HA
* Patient whose blockage region only occurred in the femoral artery or at foot.