Autologous BMMNC Combined With HA Therapy for PAOD

NCT ID: NCT03214887

Last Updated: 2022-03-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-17
• Study Completion Date: 2018-07-27

Brief 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.

Detailed 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.

Conditions

Peripheral Arterial Occlusive Disease; Critical Limb Ischemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RV-P1501-4

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

Group Type: EXPERIMENTAL

RV-P1501

Intervention Type: BIOLOGICAL

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

RV-P1501-5

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

Group Type: EXPERIMENTAL

RV-P1501

Intervention Type: BIOLOGICAL

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

RV-P1501-6

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

Group Type: EXPERIMENTAL

RV-P1501

Intervention Type: BIOLOGICAL

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

Interventions

RV-P1501

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: collaborator

National Cheng-Kung University Hospital

OTHER

Sponsor Role: collaborator

Academia Sinica, Taiwan

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Cheng Kung University Hospital

Tainan City, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

AS-IRB-BM-14056

Identifier Type: -

Identifier Source: org_study_id