Safety Study of Stem Cells Treatment in Diabetic Foot Ulcers

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 . * The Diabetic Foot Ulcer (DFU) is neuropathic: The patient is checked by a 5.27 mm Monofilament, and doesn't have a sensation in at least 4 of 9 points in the foot. * 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: * Patient weight is greater than 120 Kg. * 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.