- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01351610
Tolerability and Efficacy of Intravenous Infusion of Autologous MSC_Apceth for the Treatment of Critical Limb Ischemia
December 14, 2015 updated by: Apceth GmbH & Co. KG
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bavaria
-
Munich, Bavaria, Germany, 80331
- Isar Medizin Zentrum
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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,
Exclusion Criteria:
- 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,
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A
|
percutaneous transluminal angioplasty followed by infusion of MSC_Apceth
|
Experimental: Group B
|
percutaneous transluminal angioplasty only
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Collection of adverse events
Time Frame: one year
|
one year
|
Safety laboratory values
Time Frame: 1 year
|
1 year
|
ECG findings
Time Frame: 1 year
|
1 year
|
Analysis of inflammation markers
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Comparison of course of haemodynamic and vascular processes
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Peter Heider, MD, PhD, Isar Medizin Zentrum, München
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2011
Primary Completion (Actual)
October 1, 2014
Study Completion (Actual)
October 1, 2015
Study Registration Dates
First Submitted
May 10, 2011
First Submitted That Met QC Criteria
May 10, 2011
First Posted (Estimate)
May 11, 2011
Study Record Updates
Last Update Posted (Estimate)
December 15, 2015
Last Update Submitted That Met QC Criteria
December 14, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MSC_Apceth_001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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