Induced Wound Healing by Application of Expanded Bone Marrow Stem Cells in Diabetic Patients With Critical Limb Ischemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2009-02-28

Brief Summary

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Diabetic foot patients with chronic limb ischemia and without the option for surgical or interventional revascularization were recruited and randomized to the transplant groups or the control group within this clinical trial. These patients are randomized to control or intervention group, whereas the intervention is divided into bone marrow cells administered intramuscular or intraarterial or expanded bone marrow cells administered intramuscular or intraarterial resulting in five distinct groups. To measure the therapeutic effects of the various treatment arms patients were evaluated for (ankle brachial index (ABI), transcutaneous oxygen partial pressure (TcPO2), and reactive hyperemia (Blood Oxygen Level Dependent \[BOLD\]). Patients also underwent imaging with angiographic methods.

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Detailed Description

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Diabetic foot (DF) is a concomitant illness of diabetes mellitus. Diabetes is one of the main causes of non-traumatic amputation worldwide due to severe peripheral arterial occlusive disease with chronic critical limb ischemia being the most abundant problem. Ulceration occurs as failure of oxygenation, nutrient supply and progressive occlusion of larger blood vessels often exacerbates pre-existing microvascular abnormalities.

Purified bone marrow mononuclear cells or expanded bone marrow cells enriched in Cluster of Differentiation 90+ (CD90+) mesenchymal stem cells (named tissue repair cells, \[TRCs\]) are used in the treatment of diabetic ulcers in comparison to bone marrow derived stem cells to induce revascularization of the affected limb and to enhance local perfusion. Cells are administered intramuscular or intraarterial. A control group of patients treated according national guidelines without stem cells serves as comparator.

Diabetic foot patients with chronic limb ischemia and without the option for surgical or interventional revascularization were recruited and randomized to the transplant groups or the control group within this clinical trial. To measure the therapeutic effects of the various treatment arms patients were evaluated for (ankle brachial index (ABI), transcutaneous oxygen partial pressure (TcPO2), and reactive hyperemia (Blood Oxygen Level Dependent \[BOLD\]). Patients also underwent imaging with angiographic methods.

Conditions

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Diabetic Foot

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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control group

patients received standard of care wound treatment according guideline of the American Diabetes Association (ADA)

Group Type NO_INTERVENTION

No interventions assigned to this group

bone marrow stem cells intraarterial

bone marrow stem cells administered intraarterial

Group Type ACTIVE_COMPARATOR

bone marrow stem cells (BMC)

Intervention Type BIOLOGICAL

bone marrow stem cells

tissue repair cells intramuscular

expanded bone marrow cells enriched in CD90+ mesenchymal stem cells administered intramuscular

Group Type ACTIVE_COMPARATOR

tissue repair cells (TRC)

Intervention Type BIOLOGICAL

expanded bone marrow cells enriched in CD90+ mesenchymal stem cells

tissue repair cells intraarterial

expanded bone marrow cells enriched in CD90+ mesenchymal stem cells administered intraarterial

Group Type ACTIVE_COMPARATOR

tissue repair cells (TRC)

Intervention Type BIOLOGICAL

expanded bone marrow cells enriched in CD90+ mesenchymal stem cells

bone marrow stem cells intramuscular

bone marrow stem cells administered intramuscular

Group Type ACTIVE_COMPARATOR

bone marrow stem cells (BMC)

Intervention Type BIOLOGICAL

bone marrow stem cells

Interventions

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tissue repair cells (TRC)

expanded bone marrow cells enriched in CD90+ mesenchymal stem cells

Intervention Type BIOLOGICAL

bone marrow stem cells (BMC)

bone marrow stem cells

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Diabetes mellitus Type 1 or 2
* Peripheral occlusive arterial disease stage III or IV (Fontaine) with chronical ischemia, chronic foot ulcer, degree of severity \<5 (Wagner), older than 6 weeks, without acute wound infection
* Ulcer size 1 - 30cm2, in case of osteomyelitis only one bone should be affected no trend towards healing in the ulcer after one week of standard treatment
* Angiopathic or angioneuropathic diabetic foot syndrome with no possible option of operative or interventional revascularisation
* Age 18 - 80 years
* Declaration of patient consent

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No