Autologous BMMNC Combined With HA Therapy for PAOD

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03214887
• Date of registration: 05/07/2017
• Prospective Registration: No
• Primary sponsor: Academia Sinica, Taiwan
• Public title: Autologous BMMNC Combined With HA Therapy for PAOD
• Scientific title: Therapeutic Angiogenesis for Peripheral Artery Occlusive Disease Using Hyaluronan Combined With Autologous Bone Marrow Cell Therapy -- Phase I/II Safety and Efficacy Study
• Date of first enrolment: January 17, 2017
• Target sample size: 30
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03214887
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

Taiwan

Contacts

• Name: Patrick C.H. Hsieh, MD., PhD.

Key inclusion & exclusion 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.



Age minimum: 20 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Peripheral Arterial Occlusive Disease

Critical Limb Ischemia

Intervention(s)

Biological: RV-P1501

Primary Outcome(s)

Ankle Brachial Index (ABI) [Time Frame: Day 0, Week 4, Week 12, Week 24]

Secondary Outcome(s)

Level of pain at rest [Time Frame: Day 0, Week 1, Week 2, Week 4, Week 12, Week 24]

PWT/PFWT in seconds [Time Frame: Day 0, Week 4, Week 12, Week 24]

Biochemistry [Time Frame: Week 12, Week 24]

Ulcer size in cm2 [Time Frame: Day 0, Week 1, Week 2, Week 4, Week 12, Week 24]

Hematology [Time Frame: Week 12, Week 24]

Ulcer category [Time Frame: Day 0, Week 1, Week 2, Week 4, Week 12, Week 24]

Clinical status (Rutherford category) [Time Frame: Day 0, Week 1, Week 2, Week 4, Week 12, Week 24]

Amputation free [Time Frame: Week 1, Week 2, Week 4, Week 12, Week 24]

CT angiography [Time Frame: Week 12, Week 24]

Ejection fraction [Time Frame: Week 12, Week 24]

Secondary ID(s)

AS-IRB-BM-14056

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cheng-Kung University Hospital

National Taiwan University Hospital