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

NCT01065337 | Completed Phase 2

• 1 other identifier: HDZ-SBE-2004
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot

Keywords

peripheral arterial occlusion disease (PAD); diabetic foot; critical limb ischemia (CLI); stem cell therapy

Outcome Measures

Primary Outcomes (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

  12 months

Secondary Outcomes (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

  12 months

Study Arms (5)

control group

NO INTERVENTION

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

bone marrow stem cells intraarterial

ACTIVE COMPARATOR

bone marrow stem cells administered intraarterial

Biological: bone marrow stem cells (BMC)

tissue repair cells intramuscular

ACTIVE COMPARATOR

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

Biological: tissue repair cells (TRC)

tissue repair cells intraarterial

ACTIVE COMPARATOR

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

Biological: tissue repair cells (TRC)

bone marrow stem cells intramuscular

ACTIVE COMPARATOR

bone marrow stem cells administered intramuscular

Biological: bone marrow stem cells (BMC)

Interventions

tissue repair cells (TRC) BIOLOGICAL

expanded bone marrow cells enriched in CD90+ mesenchymal stem cells

tissue repair cells intraarterial; tissue repair cells intramuscular

bone marrow stem cells (BMC) BIOLOGICAL

bone marrow stem cells

bone marrow stem cells intraarterial; bone marrow stem cells intramuscular

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Ruhr University of Bochum: lead

Study Sites (1)

Herz- und Diabeteszentrum Nordrhein Westfalen

Bad Oeynhausen, 32545, Germany

Location

Related Publications (1)

• Kirana S, Stratmann B, Prante C, Prohaska W, Koerperich H, Lammers D, Gastens MH, Quast T, Negrean M, Stirban OA, Nandrean SG, Gotting C, Minartz P, Kleesiek K, Tschoepe D. Autologous stem cell therapy in the treatment of limb ischaemia induced chronic tissue ulcers of diabetic foot patients. Int J Clin Pract. 2012 Apr;66(4):384-93. doi: 10.1111/j.1742-1241.2011.02886.x. Epub 2012 Jan 27.

  PMID: 22284892 DERIVED

MeSH Terms

Conditions

Diabetic Foot; Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Officials

• Diethelm Tschoepe, Prof Dr Dr

  Herz- und Diabeteszentrum NRW

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Dr.

Study Record Dates

• First Submitted: February 8, 2010
• First Posted: February 9, 2010
• Study Start: August 1, 2005
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: May 25, 2012

Record last verified: 2012-05

Locations

DE (1)