Critical Limb IschemiaPhase 1NCT02336646

Cell Therapy With Mesenchymal Stem Cell in Ischemic Limb Disease

A Phase 1 study testing Allogenic MSC and Normal saline in people with Critical Limb Ischemia, run by Taiwan Bio Therapeutics Inc. at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Bone marrow MSCs will be isolated from allogenic donors, expanded under hypoxic conditions using medium containing no serum or animal-derived reagents, and applies for Phase Ⅰ/Ⅱ study in treating 18 recipients with ischemic limb diseases. Read more about this study

Who is it for?: Ages 20 to 80 years
Conditions the study is for: Critical Limb Ischemia
What is being tested?: Allogenic MSC and Normal saline
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 18 participants
Where: 1 siteTaiwan
Study dates: 1 May 2015to 20 Dec 2018
Phase: Phase 1
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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Fontaine stage > II, total walking distance < 100 m, stair < 1 floor, or ulcer / necrosis
Established critical limb ischemia, clinically and hemodynamically confirmed as per Rutherford- Ⅱ-4, Ⅲ-5, or Ⅲ-6; Patients having Infra-inguinal arterial occlusive disease with rest pain or ischemic ulcer/necrosis, who are not eligible for or have failed traditional revascularization treatment
Ankle Brachial Pressure Index (ABPI) ≤ 0.8，ankle pressure ≤ 70 mm Hg, or TcPO2 ≤ 70 mmHg in the foot
No response to medication (aspirin and cilostazol)
Normal liver and renal function
On regular medication for hypertension if any

Who cannot join

The above mentioned patients combined with infection or systemic septicemia. (ps, patients with poor control of diabetes, hypertension and hyperlipidemia will also be excluded
Patient with Immunocompromised or immunosuppressed
Type I Diabetes
Patients having stroke or myocardial infarction within last 3 months
Hb% < 10 gm%, Serum Creatinine ≥ 2mg%, Serum Total Bilirubin ≥2mg%, HbA1c > 8%

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

Taipei Veterans General Hospital
Taipei

Other trials in Taiwan

About this study

Read the detailed description

Ischemic limb disease remains one of the major causes of morbidity and mortality in the industrialized world despite the development of several new therapeutic modalities. Based on experimental data demonstrating that infusion or injection of stem/progenitor cells enhances blood flow in models of cardiovascular diseases, clinical trials were initiated in 2001 to treat patients with critical limb ischemia or cardiac ischemia with circulating blood or bone marrow-derived cells. Despite all promises, pending uncertainties and practical limitations attenuate the therapeutic use of stem/progenitor cells for ischemic limb disease. The main theme and method in the current program project, based on expertise, track record, and preliminary results of PI's laboratory, is to focus on clinical studies of using allogenic mesenchymal stem cells (MSCs), expanded under hypoxic conditions (1% O2), in treating ischemic limbs. This project is an integrated and coordinated effort aimed to overcome the regulation of cell product, and the barriers of preclinical and clinical studies. For the purposes, we have specially set up the core laboratory for stem/progenitor cells production and quality control in Cell Therapy Clean Room on the 9th floor of Medical Science Technology Building in Taipei Veterans General Hospital. We have also completed the preclinical studies in using allogenic hypoxic mouse MSCs in treating limb ischemia. In the current project, bone marrow MSCs will be isolated from allogenic donors, expanded under hypoxic conditions using medium containing no serum or animal-derived reagents, and applies for Phase Ⅰ/Ⅱ study in treating 18 recipients with ischemic limb diseases in three years.

Conditions: Critical Limb Ischemia
Being tested: Allogenic MSC, Normal saline
Medical subject headings: Chronic Limb-Threatening Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Allogenic MSCDrug
Also called Biochymal
Hypoxia-cultured human bone marrow derived mesenchymal stem cells
Normal salineDrug

Study groups in NCT02336646
Study group	Role	What they receive
Low Dose Allogenic MSC	Experimental	Low dose allogenic mesenchymal stem cells with IM injection Receives: Drug: Allogenic MSC
High Dose Allogenic MSC	Experimental	High dose allogenic mesenchymal stem cells with IM injection Receives: Drug: Allogenic MSC
Placebo	Placebo comparator	normal saline with Intramuscular injection Receives: Drug: Normal saline

What is being measured

The primary outcome is the main question the study is designed to answer.

Adverse events
Number of adverse events reported
Measured: 6 months

Secondary outcomes (4)

Efficacy-The Wong Baker FACES® pain rating scale
The Wong Baker FACES® pain rating scale, for evaluation of ischemic pain in the diseased lower limb of subjects receiving cell injection compared to placebo
Measured: 6 months
Efficacy-Transcutaneous oxygen pressure(TcPO2)
The Transcutaneous oxygen pressure (TcPO2) on foot of subjects receiving cell injection compared to placebo
Measured: 6 months
Efficacy-walking distance (TWD)
Total walking distance (TWD) on a standardized treadmill test compared to placebo
Measured: 6 months
Efficacy-Ankle Brachial Pressure Index (ABPI)
The Ankle Brachial Pressure Index (ABPI) in the lower limb of subjects receiving cell injection compared to placebo
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 201520 Dec 2018

First posted13 Jan 2015 (estimated)
Study start1 May 2015
Primary completion27 Apr 2018
Study completion20 Dec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Critical Limb IschemiaStudies 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
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02336646
Sponsor's protocol ID: 2012-02-070B
Status last verified: Nov 2015
First submitted: 8 Jan 2015
Last updated: 25 Aug 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
miRNAs in Critical Limb Ischemia (miRNACLI)
Critical Limb Ischemia
Active, not recruitingObservational study
Laser Atherectomy and Sirolimus-eluting Balloon Angioplasty for CLTI
Chronic Limb Threatening Ischemia
Recruiting
Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease
Peripheral Artery Disease, Diabetes Mellitus
RecruitingObservational study
Vessel Recoil in Specific CLTI Populations
Chronic Limb Threatening Ischemia
Not yet recruiting
DCB Outcomes After Non-Compliant Balloon Vessel Preparation With or Without Scoring in Patients With Femoropopliteal Arterial Disease
Femoropopliteal Disease, Drug Coated Balloon

All Critical Limb Ischemia trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cell Therapy With Mesenchymal Stem Cell in Ischemic Limb Disease
ClinicalTrials.gov ID: NCT02336646
Acronym / sponsor ID: 2012-02-070B
Conditions: Critical Limb Ischemia
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Taiwan Bio Therapeutics Inc.Industry (pharma, biotech, devices)
Study start: 1 May 2015 (actual)
Primary completion: 27 Apr 2018 (actual)
Study completion: 20 Dec 2018 (actual)
First posted: 13 Jan 2015 (estimated)
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Low Dose Allogenic MSC	Experimental	Drug: Allogenic MSCLow dose allogenic mesenchymal stem cells with IM injection
High Dose Allogenic MSC	Experimental	Drug: Allogenic MSCHigh dose allogenic mesenchymal stem cells with IM injection
Placebo	Placebo comparator	Drug: Normal salinenormal saline with Intramuscular injection

Who may qualify

Ages: 20 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Fontaine stage > II, total walking distance < 100 m, stair < 1 floor, or ulcer / necrosis
Established critical limb ischemia, clinically and hemodynamically confirmed as per Rutherford- Ⅱ-4, Ⅲ-5, or Ⅲ-6; Patients having Infra-inguinal arterial occlusive disease with rest pain or ischemic ulcer/necrosis, who are not eligible for or have failed traditional revascularization treatment
Ankle Brachial Pressure Index (ABPI) ≤ 0.8，ankle pressure ≤ 70 mm Hg, or TcPO2 ≤ 70 mmHg in the foot
No response to medication (aspirin and cilostazol)
Normal liver and renal function

Key exclusion criteria (5 listed)

The above mentioned patients combined with infection or systemic septicemia. (ps, patients with poor control of diabetes, hypertension and hyperlipidemia will also be excluded
Patient with Immunocompromised or immunosuppressed
Type I Diabetes
Patients having stroke or myocardial infarction within last 3 months
Hb% < 10 gm%, Serum Creatinine ≥ 2mg%, Serum Total Bilirubin ≥2mg%, HbA1c > 8%

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
Allogenic MSCAlso: BiochymalHypoxia-cultured human bone marrow derived mesenchymal stem cells	Drug	High Dose Allogenic MSC, Low Dose Allogenic MSC
Normal saline	Drug	Placebo

Primary outcome

Adverse events
Time frame: 6 months
Number of adverse events reported

4 secondary outcomes

Efficacy-The Wong Baker FACES® pain rating scale
Time frame: 6 months
Efficacy-Transcutaneous oxygen pressure(TcPO2)
Time frame: 6 months
Efficacy-walking distance (TWD)
Time frame: 6 months
Efficacy-Ankle Brachial Pressure Index (ABPI)
Time frame: 6 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.

Related trials for Critical Limb Ischemia

RecruitingObservational study
miRNAs in Critical Limb Ischemia (miRNACLI)
Critical Limb Ischemia
Active, not recruitingObservational study
Laser Atherectomy and Sirolimus-eluting Balloon Angioplasty for CLTI
Chronic Limb Threatening Ischemia
Recruiting
Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease
Peripheral Artery Disease, Diabetes Mellitus
RecruitingObservational study
Vessel Recoil in Specific CLTI Populations
Chronic Limb Threatening Ischemia
Not yet recruiting
DCB Outcomes After Non-Compliant Balloon Vessel Preparation With or Without Scoring in Patients With Femoropopliteal Arterial Disease
Femoropopliteal Disease, Drug Coated Balloon

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.

Chun Che Shih principal investigator

Taipei Veterans General Hospital, Taipei, Taiwan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Allogenic MSC and Normal saline in people with Critical Limb Ischemia, run by Taiwan Bio Therapeutics Inc. at 1 site 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this 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.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Adverse events (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02336646.

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 25 Aug 2021.