Tolerability and Efficacy of Intravenous Infusion of Auto... | NCT01351610

Studies
Tolerability and Efficacy of Intravenous Infusion of Autologous MSC_Apceth for the Treatment of Critical Limb Ischemia

NCT01351610

Sponsor

Apceth GmbH & Co. KG

Status

Completed

Last Update Posted

Dec 15, 2015Estimated

Enrollment

25Actual

Phase

Phase 1Phase 2

Conditions

Critical Limb Ischemia
Peripheral Artery Disease

Interventions

PTA + Infusion of MSC_Apceth
PTA

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

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

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2011

Primary Completion Date

Oct 2014Actual

Completion Date

Oct 2015Actual

First Submitted Date

May 10, 2011

First Submission Date that Met QC Criteria

May 10, 2011

First Posted Date

May 11, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 14, 2015

Last Update Posted Date

Dec 15, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group B	Experimental		Procedure: PTA
Group A	Experimental		Biological: PTA + Infusion of MSC_Apceth

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PTA + Infusion of MSC_Apceth	Biological	percutaneous transluminal angioplasty followed by infusion of MSC_Apceth	Group A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Collection of adverse events		one year
Safety laboratory values		1 year
ECG findings		1 year
Analysis of inflammation markers		1 year

Secondary Outcomes

Measure	Description	Time Frame
Comparison of course of haemodynamic and vascular processes		1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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,

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Peter Heider, MD, PhD	Isar Medizin Zentrum, München	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Isar Medizin Zentrum		Munich	Bavaria	80331	Germany

Condition Browse Module

MeSH Terms

ID	Term
D000089802	Chronic Limb-Threatening Ischemia
D058729	Peripheral Arterial Disease
C564658	Peripheral Arterial Occlusive Disease 1
D016491	Peripheral Vascular Diseases

Ancestor Terms

ID	Term
D050197	Atherosclerosis
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided