Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
E.Badiavas
With
United States Department of Defense
Age
18–any
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
\- 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:
1. Male or female subjects 18 years of age or older with Superficial, Intermediate or Deep 2nd Degree Burn Wounds
2. Injury within the prior 7 days
3. Subjects must understand and give written informed consent.
4. Subjects must agree to have biopsies performed as per protocol
5. Subjects must be accessible for weekly wound treatment and assessment visits
6. 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).
7. Maximum wound size limited to:
* Single wound: ≤ 5% body surface area (BSA)
* Multiple wounds treated in a defined anatomical region with ≤ 20% cumulative BSA.
8. Diabetic subjects: HbA1c ≤ 8%
You may not be if
1. Solely 1st degree or solely 3rd degree burns
2. Subjects with superficial 2nd degree burn who are expected to heal within 2 weeks post standard therapy
3. Evidence of active infection at the wound site
4. Evidence of significant wound healing prior to treatment
5. Wound located in the area of fingers, toes, face, or perineum
6. Wound where 75% or more extends across joints
7. Electrical or chemical burns
8. Have any requirement for the use of systemic steroids or immunosuppressive
9. Subjects Allergic to human albumin, streptomycin, or penicillin
10. Be a pregnant female or nursing mother
11. Subjects who are known or found to be HIV positive
12. Current history of alcohol or substance abuse or history of alcohol or substance abuse requiring treatment within the past 12 months
13. Patients with severe medical conditions
1. Malignancy (other than non melanoma skin cancer) not in remission or in remission less than 5 years
2. Life expectancy less than two years
3. Severe cardiopulmonary disease restricting ambulation to the clinical facility
14. 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.
15. Subjects with abnormal bilirubin levels.
16. Subjects with abnormal PT/INR laboratory values while not on chronic anticoagulant treatment which can be held for minor surgical procedures
17. Those with a known history of coagulopathy
18. Subjects who are potential recipients of tissue or organ transplantation
19. Subjects with circulating Hepatitis B antigen and/or who are seropositive for Hepatitis C antibody
20. History of poor compliance, unreliability
Clareo Health | Stem Cell Therapy to Improve Burn Wound Healing
