Stem Cell Therapy to Improve Burn Wound Healing

• Donors:

Eligibility Criteria:

• No history of malignancy
• No active coagulopathy and/or hypocoagulable state
• No history of cardio/pulmonary conditions
• Negative tests for Hepatitis A, Hepatitis B, Hepatitis C, RPR, HIV 1 / 2, HTLV I/II, Chagas Disease, NAT for HCV, HIV and WNV.
• Hemoglobin ≥ 13.0 g/dL
• Platelet count 140,000 to 440,000/ul
• WBC 3.0 to 11.0 K/ul
• BNP ≤ 100 pg /mL
• No anomalies on the CBC and differential suggestive of a hematopoietic disorder
• Creatinine ≤ 1.5 mg/dL
• ALT ≤ 112 IU/L
• AST ≤ 100 IU/L
• Bilirubin < 1.5 mg/dL
• No diabetes
• Systolic blood pressure ≤ 170
• Diastolic blood pressure ≤ 90
• No history of autoimmune disorders

Recipients:

Inclusion criteria

• Male or female subjects 18 years of age or older with Superficial, Intermediate or Deep 2nd Degree Burn Wounds
• Injury within the prior 7 days
• Subjects must understand and give written informed consent.
• Subjects must agree to have biopsies performed as per protocol
• Subjects must be accessible for weekly wound treatment and assessment visits
• Males and females must agree to use an acceptable method of contraception. Exceptions will be females of non-childbearing age and monogamous males who are partners of females of non-childbearing age. Acceptable methods of birth control include; history of sterilization, birth control pills, depoprogesterone injections, a barrier contraceptive such as a condom with or without spermicide cream or gel, diaphragms or cervical cap with or without spermicide cream or gel, or an intrauterine device (IUD).
• Maximum wound size limited to:

• Single wound: ≤ 5% body surface area (BSA)
• Multiple wounds treated in a defined anatomical region with ≤ 20% cumulative BSA.
• Diabetic subjects: HbA1c ≤ 8%

Exclusion criteria

• Solely 1st degree or solely 3rd degree burns
• Subjects with superficial 2nd degree burn who are expected to heal within 2 weeks post standard therapy
• Evidence of active infection at the wound site
• Evidence of significant wound healing prior to treatment
• Wound located in the area of fingers, toes, face, or perineum
• Wound where 75% or more extends across joints
• Electrical or chemical burns
• Have any requirement for the use of systemic steroids or immunosuppressive
• Subjects Allergic to human albumin, streptomycin, or penicillin
• Be a pregnant female or nursing mother
• Subjects who are known or found to be HIV positive
• Current history of alcohol or substance abuse or history of alcohol or substance abuse requiring treatment within the past 12 months
• Patients with severe medical conditions

• Malignancy (other than non melanoma skin cancer) not in remission or in remission less than 5 years
• Life expectancy less than two years
• Severe cardiopulmonary disease restricting ambulation to the clinical facility
• WBC <3 or > 10 x10⁹/L, Hgb < 9g/dL, platelets count 100x10⁹/L or less, serum creatinine > 1.5 times the upper normal limit, AST or ALT > 2.5 times the upper normal limit.
• Subjects with abnormal bilirubin levels.
• Subjects with abnormal PT/INR laboratory values while not on chronic anticoagulant treatment which can be held for minor surgical procedures
• Those with a known history of coagulopathy
• Subjects who are potential recipients of tissue or organ transplantation
• Subjects with circulating Hepatitis B antigen and/or who are seropositive for Hepatitis C antibody
• History of poor compliance, unreliability