Safety Study of Stem Cells Treatment in Diabetic Foot Ulcers

U.S. FDA Resources

Estimated Enrollment:	20
Study Start Date:	January 2013
Estimated Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Inclusion Criteria:

• Patient signed informed consent.
• Adult males or females between 18 and 81 years of age with diabetes mellitus type 1 or type 2.
• Patient has one Diabetic Foot Ulcer (DFU) on the treated leg. The size of the DFU is no greater than 10 cm2 .
• No endovascular or surgical interventions are planned.
• Patient isn't in an immediate life threat.

• Normal organ and marrow function as defined:

  1. Leukocytes ≥3,000/μL
  2. Absolute neutrophil count ≥1,500/μL
  3. Platelets ≥140,000/μL
  4. AST (SGOT)/ALT (SGPT) ≤2.5 X institutional standards range
  5. Creatinine ≤ 2.5 mg/dL
• Patients with controlled blood pressure (defined as a systolic blood pressure ≤180 and/or a diastolic blood pressure of ≤110 mmHg) and established anti-hypertensive therapy as necessary prior to entry into the study.

Exclusion Criteria:

• Patients with poorly controlled diabetes mellitus (HbA1c > 10%).
• Presence of osteomyelitis (stage B grade 3 and stage D grade 3 on the UT Scale).
• More than one ulcer in the treated foot.
• Patients with a known failed ipsilateral revascularization procedure within 4 weeks prior to enrollment.
• Patients with ABI <= 0.3
• Patients receiving treatment with hematopoietic growth factors.
• (Actively) infected ulcer.
• Infection of the involved extremity(ies) in the intended region of injection. Patient will be included (injected) if there is a safe zone of 10 cm from any soft tissue infection, manifested by fever, purulence and severe cellulitis.
• Active wet gangrenous tissue.
• Patients who require uninterrupted anticoagulation or anti-platelet therapy [i.e. anticoagulation therapy (e.g. Coumadin) that cannot be stopped for 72 hours prior to intramuscular injections.
• Patients with a blood clotting disorder not caused by medication.
• Patients with known cancer undergoing treatment including chemotherapy, radiotherapy or immunotherapy.
• Patients with end stage renal disease requiring dialysis.
• Patients who are pregnant or lactating.
• History of regular alcohol consumption exceeding 2 drinks/day (1 drink = 5 oz [150mL] of wine or 12 oz [360mL] of beer or 1.5 oz [45mL] of hard liquor) within 6 months of screening and/or history of illicit drug use.
• Known allergies to protein products (horse or bovine serum, or porcine trypsin) used in the cell production process.
• Patients receiving experimental medications or participating in another clinical study within 30 days of screening.
• Immune deficient patients.
• Patients with positive blood tests for Hepatitis B or Hepatitis C or HIV or Syphilis at the time of screening.
• Patients treated by Ilomedin (Iloprost).
• Patients having received a new chronic pharmacologic treatment regimen within 4 weeks prior to enrollment.
• Patients undergoing hyperbaric oxygen treatment within 4 weeks of inclusion and/or required throughout the trial.
• Concomitant wound treatments that include growth factors or tissue engineered products.
• In the opinion of the investigator, the patient is unsuitable for cellular therapy.
• Patients receiving systemic or direct target limb injection of antiangiogenic drugs.

Sheba Medical Center

Diabetic mellitus Diabetic foot ulcers Ischemic Limb

Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Ulcer Foot Ulcer Diabetic Foot Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases

Pathologic Processes Foot Diseases Skin Diseases Leg Ulcer Skin Ulcer Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases Diabetes Complications Diabetic Neuropathies