Peripheral Arterial Occlusive DiseasePhase 1/2NCT03214887
Autologous BMMNC Combined With HA Therapy for PAOD
A Phase 1/2 study testing RV-P1501 in people with Peripheral Arterial Occlusive Disease and Critical Limb Ischemia, run by Academia Sinica, Taiwan at 2 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Peripheral Arterial Occlusive Disease, Critical Limb Ischemia
- What is being tested?
- RV-P1501
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesTaiwan
- Study dates
- 17 Jan 2017to 27 Jul 2018
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
2 sites in 1 country.
Taiwan2 sites
National Cheng Kung University Hospital
Tainan, 704
National Taiwan University Hospital
Taipei, 100
About this study
Official title: Therapeutic Angiogenesis for Peripheral Artery Occlusive Disease Using Hyaluronan Combined With Autologous Bone Marrow Cell Therapy -- Phase I/II Safety and Efficacy Study
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.
Read the 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.
- Being tested
- RV-P1501
- Keywords
- Hyaluronan, Bone marrow mononuclear cells
- Medical subject headings
- Peripheral Arterial Occlusive Disease 1, Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RV-P1501Biological
Gel-like product with BMMNCs in each ml of hyaluronan (HA) solution
| Study group | Role | What they receive |
|---|---|---|
| RV-P1501-4 | Experimental | Gel-like product with 10 thousand BMMNCs in each ml of 1% hyaluronan (HA) solution Receives: Biological: RV-P1501 |
| RV-P1501-5 | Experimental | Gel-like product with 100 thousand BMMNCs in each ml of 1% hyaluronan (HA) solution Receives: Biological: RV-P1501 |
| RV-P1501-6 | Experimental | Gel-like product with 1 million BMMNCs in each ml of 1% hyaluronan (HA) solution Receives: Biological: RV-P1501 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ankle Brachial Index (ABI)
The percentage change of ABI from 3 follow-ups with the baseline.
Measured: Day 0, Week 4, Week 12, Week 24
Secondary outcomes (10)
Clinical status (Rutherford category)
Improvement in Rutherford scale was recorded at baseline and each follow-up.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 0, Week 4, Week 12, Week 24
Amputation free
Time to below the knee amputation of the ipsilateral leg after the treatment.
Measured: Week 1, Week 2, Week 4, Week 12, Week 24
Ejection fraction
Ejection fraction was measured by echocardiogram to record the cardiac function at W12 and W24.
Measured: Week 12, Week 24
CT angiography
CT angiography was performed to record the morphology of blood vessel, location, and the vessel cross section percentage.
Measured: Week 12, Week 24
Biochemistry
Biochemistry tests were performed to interpret the health assessment at W12 and W24.
Measured: Week 12, Week 24
Hematology
Hematology tests were performed to interpret the health assessment at W12 and W24.
Measured: Week 12, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2017
- Study start17 Jan 2017
- Primary completion30 Jun 2018 (estimated)
- Study completion27 Jul 2018
Why it stopped: Incomplete enrollment process
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial Occlusive DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Academia Sinica, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03214887
- Sponsor's protocol ID
- AS-IRB-BM-14056
- Status last verified
- Mar 2022
- First submitted
- 5 Jul 2017
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Angiogenesis for Peripheral Artery Occlusive Disease Using Hyaluronan Combined With Autologous Bone Marrow Cell Therapy -- Phase I/II Safety and Efficacy Study
- ClinicalTrials.gov ID
- NCT03214887
- Acronym / sponsor ID
- AS-IRB-BM-14056
- Keywords
- Hyaluronan, Bone marrow mononuclear cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Incomplete enrollment process
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Academia Sinica, TaiwanUniversity, hospital or other
- Collaborators
- National Taiwan University Hospital, National Cheng-Kung University Hospital
- Study start
- 17 Jan 2017 (actual)
- Primary completion
- 30 Jun 2018 (estimated)
- Study completion
- 27 Jul 2018 (actual)
- First posted
- 12 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| RV-P1501-4 | Experimental | Biological: RV-P1501Gel-like product with 10 thousand BMMNCs in each ml of 1% hyaluronan (HA) solution |
| RV-P1501-5 | Experimental | Biological: RV-P1501Gel-like product with 100 thousand BMMNCs in each ml of 1% hyaluronan (HA) solution |
| RV-P1501-6 | Experimental | Biological: RV-P1501Gel-like product with 1 million BMMNCs in each ml of 1% hyaluronan (HA) solution |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (16 listed)
- Patient undergone any organ transplantation
- Inability to undergo bone marrow aspiration
- Pregnant woman
- Life expectancy < 1 year
- Cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RV-P1501Gel-like product with BMMNCs in each ml of hyaluronan (HA) solution | Biological | RV-P1501-4, RV-P1501-5, RV-P1501-6 |
Primary outcome
Ankle Brachial Index (ABI)
Time frame: Day 0, Week 4, Week 12, Week 24
The percentage change of ABI from 3 follow-ups with the baseline.
10 secondary outcomes
Clinical status (Rutherford category)
Time frame: Day 0, Week 1, Week 2, Week 4, Week 12, Week 24
Level of pain at rest
Time frame: Day 0, Week 1, Week 2, Week 4, Week 12, Week 24
Ulcer size in cm2
Time frame: Day 0, Week 1, Week 2, Week 4, Week 12, Week 24
Ulcer category
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
Amputation free
Time frame: Week 1, Week 2, Week 4, Week 12, Week 24
Ejection fraction
Time frame: Week 12, Week 24
CT angiography
Time frame: Week 12, Week 24
Biochemistry
Time frame: Week 12, Week 24
Hematology
Time frame: Week 12, Week 24
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing RV-P1501 in people with Peripheral Arterial Occlusive Disease and Critical Limb Ischemia, run by Academia Sinica, Taiwan at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ankle Brachial Index (ABI) (time frame: Day 0, Week 4, Week 12, Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2022.