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

Ruhr University of Bochum

Status and phase: Completed; Phase 2

Conditions: Diabetic Foot

Treatments: Biological: bone marrow stem cells (BMC); Biological: tissue repair cells (TRC)

Study type: Interventional

Funder types: Other

Identifiers

NCT01065337

HDZ-SBE-2004

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 5 patient groups

control group

No Intervention group

Description:

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

bone marrow stem cells intraarterial

Active Comparator group

Description:

bone marrow stem cells administered intraarterial

Treatment:

Biological: bone marrow stem cells (BMC)

tissue repair cells intramuscular

Active Comparator group

Description:

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

Treatment:

Biological: tissue repair cells (TRC)

tissue repair cells intraarterial

Active Comparator group

Description:

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

Treatment:

Biological: tissue repair cells (TRC)

bone marrow stem cells intramuscular

Active Comparator group

Description:

bone marrow stem cells administered intramuscular

Treatment:

Biological: bone marrow stem cells (BMC)