Critical Limb IschemiaPhase 1/2NCT01351610
Tolerability and Efficacy of Intravenous Infusion of Autologous MSC_Apceth for the Treatment of Critical Limb Ischemia
A Phase 1/2 study testing PTA + Infusion of MSC_Apceth and PTA in people with Critical Limb Ischemia and Peripheral Artery Disease, run by Apceth GmbH & Co. KG at 1 site in Germany.
Trial summary
MSC_Apceth are GMP-manufactured, autologous ex-vivo expanded non-hemapoietic bone-marrow derived stem cells for the treatment of Critical Limb Ischemia Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Critical Limb Ischemia, Peripheral Artery Disease
- What is being tested?
- PTA + Infusion of MSC_Apceth and PTA
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2011to Oct 2015
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with peripheral arterial occlusive disease (symptomatic PAOD), diagnosis of CLI defined as persistent, recurring ischemic rest pain for at least 2 weeks, and/or ulceration or gangrene of the foot or toe, with an ABPI </= 0.5,
- Patients with staging of ≥III according to Fontaine and ≥4 according to Rutherford categories,
- Patients fulfilling the criteria for an invasive re-vascularisation procedure (PTA) at the discretion of the investigator,
- Patients without major amputation of the lower extremities within the period of 6 months after inclusion in the opinion of the investigator,
Who cannot join
- Patients with wounds of a severity of greater than grade 2 on the Wagner Scale,
- Patients with life-threatening ventricular arrhythmia,
- Patients with unstable angina pectoris,
- Patients with severe congestive heart failure (i.e. NYHA Stage IV),
- Patients with uncontrolled hypertension (defined as diastolic blood pressure >110 mmHg or systolic blood pressure >180 mmHg during screening),
- Patients with an uncontrolled diabetes mellitus (HbA1c > 9%),
- Patients having any history of malignant tumour in the anamnesis or are currently on tumour treatment,
- Patients who are unsuitable for a MSC stem cell therapy in the opinion of the investigator,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open, Randomized, Mono-Centre, Two-Parallel Group Clinical Phase I/II Trial on the Evaluation of Tolerability and Efficacy of an Intravenous Infusion of Human Bone Marrow Derived Autologous, CD34-Negative Mesenchymal Stem Cells for the Treatment of Critical Limb Ischemia in Patients With Advanced Peripheral Arterial Occlusive Disease Subsequent to Percutaneous Transluminal Angioplasty
MSC_Apceth are GMP-manufactured, autologous ex-vivo expanded non-hemapoietic bone-marrow derived stem cells for the treatment of Critical Limb Ischemia
- Conditions
- Critical Limb Ischemia, Peripheral Artery Disease
- Being tested
- PTA + Infusion of MSC_Apceth, PTA
- Keywords
- Critical Limb Ischemia, Peripheral Arterial Occlusive Disease, Peripheral Artery Disease, Peripheral Vascular Disease, Stem Cell Therapy, Mesenchymal Stem Cells
- Medical subject headings
- Chronic Limb-Threatening Ischemia, Peripheral Arterial Disease, Peripheral Arterial Occlusive Disease 1, Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTA + Infusion of MSC_ApcethBiological
percutaneous transluminal angioplasty followed by infusion of MSC_Apceth
PTAProcedure or surgery
percutaneous transluminal angioplasty only
| Study group | Role | What they receive |
|---|---|---|
| Group B | Experimental | Not described Receives: Procedure: PTA |
| Group A | Experimental | Not described Receives: Biological: PTA + Infusion of MSC_Apceth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of adverse events
Measured: one year
Safety laboratory values
Measured: 1 year
ECG findings
Measured: 1 year
Analysis of inflammation markers
Measured: 1 year
Secondary outcomes (1)
Comparison of course of haemodynamic and vascular processes
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2011 (estimated)
- Study startMar 2011
- Primary completionOct 2014
- Study completionOct 2015
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Apceth GmbH & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Heider, MD, PhD, Principal investigator, Isar Medizin Zentrum, München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01351610
- Sponsor's protocol ID
- MSC_Apceth_001
- Status last verified
- Dec 2015
- First submitted
- 10 May 2011
- Last updated
- 15 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open, Randomized, Mono-Centre, Two-Parallel Group Clinical Phase I/II Trial on the Evaluation of Tolerability and Efficacy of an Intravenous Infusion of Human Bone Marrow Derived Autologous, CD34-Negative Mesenchymal Stem Cells for the Treatment of Critical Limb Ischemia in Patients With Advanced Peripheral Arterial Occlusive Disease Subsequent to Percutaneous Transluminal Angioplasty
- ClinicalTrials.gov ID
- NCT01351610
- Acronym / sponsor ID
- MSC_Apceth_001
- Conditions
- Critical Limb Ischemia, Peripheral Artery Disease
- Keywords
- Critical Limb Ischemia, Peripheral Arterial Occlusive Disease, Peripheral Artery Disease, Peripheral Vascular Disease, Stem Cell Therapy, Mesenchymal Stem Cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Apceth GmbH & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 11 May 2011 (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.
MSC_Apceth are GMP-manufactured, autologous ex-vivo expanded non-hemapoietic bone-marrow derived stem cells for the treatment of Critical Limb Ischemia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group B | Experimental | Procedure: PTA |
| Group A | Experimental | Biological: PTA + Infusion of MSC_Apceth |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with peripheral arterial occlusive disease (symptomatic PAOD), diagnosis of CLI defined as persistent, recurring ischemic rest pain for at least 2 weeks, and/or ulceration or gangrene of the foot or toe, with an ABPI </= 0.5,
- Patients with staging of ≥III according to Fontaine and ≥4 according to Rutherford categories,
- Patients fulfilling the criteria for an invasive re-vascularisation procedure (PTA) at the discretion of the investigator,
- Patients without major amputation of the lower extremities within the period of 6 months after inclusion in the opinion of the investigator,
Key exclusion criteria (8 listed)
- Patients with wounds of a severity of greater than grade 2 on the Wagner Scale,
- Patients with life-threatening ventricular arrhythmia,
- Patients with unstable angina pectoris,
- Patients with severe congestive heart failure (i.e. NYHA Stage IV),
- Patients with uncontrolled hypertension (defined as diastolic blood pressure >110 mmHg or systolic blood pressure >180 mmHg during screening),
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 |
|---|---|---|
| PTA + Infusion of MSC_Apcethpercutaneous transluminal angioplasty followed by infusion of MSC_Apceth | Biological | Group A |
| PTApercutaneous transluminal angioplasty only | Procedure or surgery | Group B |
Primary outcome
Collection of adverse events
Time frame: one year
Safety laboratory values
Time frame: 1 year
ECG findings
Time frame: 1 year
Analysis of inflammation markers
Time frame: 1 year
1 secondary outcome
Comparison of course of haemodynamic and vascular processes
Time frame: 1 year
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 15 Dec 2015.
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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.
Peter Heider, MD, PhD principal investigator
Isar Medizin Zentrum, München
1 site 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 PTA + Infusion of MSC_Apceth and PTA in people with Critical Limb Ischemia and Peripheral Artery Disease, run by Apceth GmbH & Co. KG at 1 site in Germany.
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 4 inclusion and 8 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 15 Dec 2015. 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 Germany. 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 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?
Collection of adverse events (time frame: one year). The study lists 4 primary outcomes in all. 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 Dec 2015.