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 range
20 Years
Sex
ALL
See this in plain English?
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.