Autologous BMMNC Combined With HA Therapy for PAOD

Academia Sinica, Taiwan

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: Peripheral Arterial Occlusive Disease; Critical Limb Ischemia

Treatments: Biological: RV-P1501

Study type: Interventional

Funder types: Other

Identifiers

NCT03214887

AS-IRB-BM-14056

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

RV-P1501-4

Experimental group

Description:

Gel-like product with 10 thousand BMMNCs in each ml of 1% hyaluronan (HA) solution

Treatment:

Biological: RV-P1501

RV-P1501-5

Experimental group

Description:

Gel-like product with 100 thousand BMMNCs in each ml of 1% hyaluronan (HA) solution

Treatment:

Biological: RV-P1501

RV-P1501-6

Experimental group

Description:

Gel-like product with 1 million BMMNCs in each ml of 1% hyaluronan (HA) solution

Treatment:

Biological: RV-P1501