Autologous BMMNC Combined With HA Therapy for PAOD

Academia Sinica, Taiwan

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Peripheral Arterial Occlusive Disease Critical Limb Ischemia

Interventions

RV-P1501BIOLOGICAL

Gel-like product with BMMNCs in each ml of hyaluronan (HA) solution

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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.

Locations (2)

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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