Autologous BMMNC Combined With HA Therapy for PAOD

NCT03214887 | Withdrawn Phase 1 DMC

• 1 other identifier: AS-IRB-BM-14056
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Peripheral Arterial Occlusive Disease; Critical Limb Ischemia

Keywords

Hyaluronan; Bone marrow mononuclear cells

Outcome Measures

Primary Outcomes (1)

• Ankle Brachial Index (ABI)

  The percentage change of ABI from 3 follow-ups with the baseline.

  Day 0, Week 4, Week 12, Week 24

Secondary Outcomes (10)

• Clinical status (Rutherford category)

  Day 0, Week 1, Week 2, Week 4, Week 12, Week 24

• Level of pain at rest

  Day 0, Week 1, Week 2, Week 4, Week 12, Week 24

• Ulcer size in cm2

  Day 0, Week 1, Week 2, Week 4, Week 12, Week 24

• Ulcer category

  Day 0, Week 1, Week 2, Week 4, Week 12, Week 24

• PWT/PFWT in seconds

  Day 0, Week 4, Week 12, Week 24

Study Arms (3)

RV-P1501-4

EXPERIMENTAL

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

Biological: RV-P1501

RV-P1501-5

EXPERIMENTAL

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

Biological: RV-P1501

RV-P1501-6

EXPERIMENTAL

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

Biological: RV-P1501

Interventions

RV-P1501 BIOLOGICAL

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

RV-P1501-4; RV-P1501-5; RV-P1501-6

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Academia Sinica, Taiwan: lead
• National Taiwan University Hospital: collaborator
• National Cheng-Kung University Hospital: collaborator

Study Sites (2)

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Peripheral Arterial Occlusive Disease 1; Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: RV-P1501-4: Gel-like product with 10 thousand BMMNCs in each ml of 1% hyaluronan (HA) solution RV-P1501-5: Gel-like product with 100 thousand BMMNCs in each ml of 1% hyaluronan (HA) solution RV-P1501-6: Gel-like product with 1 million BMMNCs in each ml of 1% hyaluronan (HA) solution

Study Record Dates

• First Submitted: July 5, 2017
• First Posted: July 12, 2017
• Study Start: January 17, 2017
• Primary Completion: June 30, 2018
• Study Completion: July 27, 2018
• Last Updated: March 15, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)