Safety Study of Stem Cells Treatment in Diabetic Foot Ulcers

This is an interventional treatment trial for Type I Diabetes Mellitus With Ulcer focused on measuring Diabetic mellitus, Diabetic foot ulcers, Ischemic Limb Read More

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.