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OpenTrials
Completed

NCT Number: NCT01351610

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

MSC_Apceth are GMP-manufactured, autologous ex-vivo expanded non-hemapoietic bone-marrow derived stem cells for the treatment of Critical Limb Ischemia

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Key information

Conditions

Critical Limb Ischemia Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Chronic Disease Chronic Limb-Threatening Ischemia Disease Attributes Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Arterial Occlusive Disease 1 Peripheral Artery Disease Peripheral Vascular Diseases Vascular Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Isar Medizin Zentrum

Munich, Bavaria, 80331, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

PTA + Infusion of MSC_Apceth

Biological

percutaneous transluminal angioplasty followed by infusion of MSC_Apceth

PTA

Procedure

percutaneous transluminal angioplasty only

Primary outcomes

  1. Collection of adverse events

    Time frame: one year

  2. Safety laboratory values

    Time frame: 1 year

  3. ECG findings

    Time frame: 1 year

  4. Analysis of inflammation markers

    Time frame: 1 year

Secondary outcomes

  1. Comparison of course of haemodynamic and vascular processes

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Apceth GmbH & Co. KG

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
May 11, 2011
Registry last updated
Dec 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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