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

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ClinicalTrials.gov Identifier: NCT01065337
Recruitment Status : Completed
First Posted : February 9, 2010
Last Update Posted : May 25, 2012
Sponsor:
Information provided by (Responsible Party):
Diethelm Tschoepe, Ruhr University of Bochum

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Biological: tissue repair cells (TRC) Biological: bone marrow stem cells (BMC) Phase 2

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study on Induced Wound Healing Through Application of Expanded Autologous Bone Marrow Stem Cells in Diabetic Patients With Ischemia-induced Chronic Tissue Ulcers Affecting the Lower Limbs
Study Start Date : August 2005
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

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Arms and Interventions
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Arm Intervention/treatment
No Intervention: control group
patients received standard of care wound treatment according guideline of the American Diabetes Association (ADA)
Active Comparator: bone marrow stem cells intraarterial
bone marrow stem cells administered intraarterial
 Biological: bone marrow stem cells (BMC)
bone marrow stem cells
Active Comparator: tissue repair cells intramuscular
expanded bone marrow cells enriched in CD90+ mesenchymal stem cells administered intramuscular
 Biological: tissue repair cells (TRC)
expanded bone marrow cells enriched in CD90+ mesenchymal stem cells
Active Comparator: tissue repair cells intraarterial
expanded bone marrow cells enriched in CD90+ mesenchymal stem cells administered intraarterial
 Biological: tissue repair cells (TRC)
expanded bone marrow cells enriched in CD90+ mesenchymal stem cells
Active Comparator: bone marrow stem cells intramuscular
bone marrow stem cells administered intramuscular
 Biological: bone marrow stem cells (BMC)
bone marrow stem cells


Outcome Measures
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Primary Outcome Measures :
  1. The patient is alive, the patient has not undergone any major amputation, complete primary wound healing has been achieved, no ipsilateral relapse has occurred [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Rate major amputations Rate of patients with complete ulcer healing Rate of treatment related complications Improvement of ankle brachial index (ABI) Improvement of transcutaneous oxygen partial pressure (TcPO2) Improvement of local perfusion [ Time Frame: 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01065337


Locations
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Germany
Herz- und Diabeteszentrum Nordrhein Westfalen
Bad Oeynhausen, Germany, 32545
Sponsors and Collaborators
Ruhr University of Bochum
Investigators
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Principal Investigator: Diethelm Tschoepe, Prof Dr Dr Herz- und Diabeteszentrum NRW
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Diethelm Tschoepe, Prof. Dr. Dr., Ruhr University of Bochum
ClinicalTrials.gov Identifier: NCT01065337    
Other Study ID Numbers: HDZ-SBE-2004
First Posted: February 9, 2010    Key Record Dates
Last Update Posted: May 25, 2012
Last Verified: May 2012
Keywords provided by Diethelm Tschoepe, Ruhr University of Bochum:
peripheral arterial occlusion disease (PAD)
diabetic foot
critical limb ischemia (CLI)
stem cell therapy
Additional relevant MeSH terms:
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Diabetic Foot
Pathologic Processes
Diabetic Angiopathies
Foot Ulcer
Leg Ulcer
Skin Ulcer
Diabetic Neuropathies
 Ischemia
Vascular Diseases
Cardiovascular Diseases
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases