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

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

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01351610

Enrollment

Registered

2011-05-11

Start date

2011-03-31

Completion date

2015-10-31

Last updated

2015-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Brief summary

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

Interventions

BIOLOGICALPTA + Infusion of MSC_Apceth

percutaneous transluminal angioplasty followed by infusion of MSC\_Apceth

PROCEDUREPTA

percutaneous transluminal angioplasty only

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

Healthy volunteers

Inclusion criteria

1. 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, 2. Patients with staging of ≥III according to Fontaine and ≥4 according to Rutherford categories, 3. Patients fulfilling the criteria for an invasive re-vascularisation procedure (PTA) at the discretion of the investigator, 4. Patients without major amputation of the lower extremities within the period of 6 months after inclusion in the opinion of the investigator,

Exclusion criteria

1. Patients with wounds of a severity of greater than grade 2 on the Wagner Scale, 2. Patients with life-threatening ventricular arrhythmia, 3. Patients with unstable angina pectoris, 4. Patients with severe congestive heart failure (i.e. NYHA Stage IV), 5. Patients with uncontrolled hypertension (defined as diastolic blood pressure \>110 mmHg or systolic blood pressure \>180 mmHg during screening), 6. Patients with an uncontrolled diabetes mellitus (HbA1c \> 9%), 7. Patients having any history of malignant tumour in the anamnesis or are currently on tumour treatment, 8. Patients who are unsuitable for a MSC stem cell therapy in the opinion of the investigator,

Design outcomes

Primary

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

Secondary

Measure	Time frame
Comparison of course of haemodynamic and vascular processes	1 year

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026