A Phase 1/2 interventional study of RV-P1501 in Peripheral Arterial Occlusive Disease and Critical Limb Ischemia, sponsored by Academia Sinica, Taiwan. Withdrawn at 2 sites in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2022-03-15.
Sponsored by Academia Sinica, Taiwan · Phase 1/2, Interventional, and Treatment
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.
This is a multicenter, non-blinded and randomized study to evaluate the safety and efficacy of hyaluronan (HA) combined with autologous bone marrow mononuclear cells (BMMNC) therapy for critical peripheral arterial occlusive disease (PAOD) patients.
A total of 30 subjects will be recruited into the study. The subjects will be randomized into 3 different arms. During the Phase I study, 9 subjects recruited while another 21 additional subjects will be recruited in Phase II after the review of DSMB and consultation of Taiwan FDA on the results of the Phase I study.
Each subject will be administered 5\~10 injections of RV-P1501, the number of injections depends on the size of the subject's ischemic leg. Each subject will receive treatment once. Subjects will be assigned to the treatments in random order. Evaluations including ABI, PWT/PFWT, clinical status, EF, CTA, biochemistry and hematology checked during the inclusion and exclusion evaluation, and will be taken at baseline, 1 week, 2 weeks, 4 weeks, 12 weeks, and 24 weeks after the treatment.
348 studies on the registry are indexed under Chronic Limb-Threatening Ischemia; 70 are open to participants now.
Browse Chronic Limb-Threatening Ischemia studies →Academia Sinica, Taiwan is the lead sponsor of 15 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Gel-like product with 10 thousand BMMNCs in each ml of 1% hyaluronan (HA) solution
Biological: RV-P1501
Gel-like product with 100 thousand BMMNCs in each ml of 1% hyaluronan (HA) solution
Biological: RV-P1501
Gel-like product with 1 million BMMNCs in each ml of 1% hyaluronan (HA) solution
Biological: RV-P1501
Gel-like product with BMMNCs in each ml of hyaluronan (HA) solution
Ankle Brachial Index (ABI)
The percentage change of ABI from 3 follow-ups with the baseline.
Time frame: Day 0, Week 4, Week 12, Week 24
Clinical status (Rutherford category)
Improvement in Rutherford scale was recorded at baseline and each follow-up.
Time frame: Day 0, Week 1, Week 2, Week 4, Week 12, Week 24
Level of pain at rest
Rest pain was measured using Wong-Baker FACES pain rating scale at baseline and each follow-up visit.
Time frame: Day 0, Week 1, Week 2, Week 4, Week 12, Week 24
Ulcer size in cm2
Ulcer size was assessed and measured at each follow-up interval and compared to baseline.
Time frame: Day 0, Week 1, Week 2, Week 4, Week 12, Week 24
Ulcer category
Ulcer status was assessed at each follow-up interval and compared to baseline.
Time frame: Day 0, Week 1, Week 2, Week 4, Week 12, Week 24
PWT/PFWT in seconds
Peak walking time and pain-free walking time was measured at baseline and compared to W4, W12 and W24 by treadmill walking tests.
Time frame: Day 0, Week 4, Week 12, Week 24
Amputation free
Time to below the knee amputation of the ipsilateral leg after the treatment.
Time frame: Week 1, Week 2, Week 4, Week 12, Week 24
Ejection fraction
Ejection fraction was measured by echocardiogram to record the cardiac function at W12 and W24.
Time frame: Week 12, Week 24
CT angiography
CT angiography was performed to record the morphology of blood vessel, location, and the vessel cross section percentage.
Time frame: Week 12, Week 24
Biochemistry
Biochemistry tests were performed to interpret the health assessment at W12 and W24.
Time frame: Week 12, Week 24
Hematology
Hematology tests were performed to interpret the health assessment at W12 and W24.
Time frame: Week 12, Week 24
Plan to share: No
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This study is withdrawn, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Academia Sinica, Taiwan