Study of the Effectiveness of Autologous Bone Marrow-Derived Mesenchymal Stem Cells in Fibrin to Treat Chronic Wounds
Non Healing Wounds
About this trial
This is an interventional treatment trial for Non Healing Wounds focused on measuring Stem Cells, chronic wounds, fibrin, Bone marrow-derived mesenchymal stem cells
Eligibility Criteria
Inclusion Criteria:
-
A subject must meet the following conditions in order to be included in this trial:
- Male or female subjects 18 years of age or older with chronic wounds
- Wound present for at least 3 months with no evidence of healing
- Wound size must be less than or equal to 15 cm2 at randomization
- Subjects must understand and give written informed consent
- Subjects must agree to have biopsies performed as per protocol
Exclusion Criteria:
The presence of the following circumstances classifies a subject as unacceptable for inclusion in this trial:
- Evidence of active infection at the wound site or around the ulcer
- Requirement for the use of systemic corticosteroids or immuno- suppressive agents
- The subject is pregnant or breast-feeding
- The subject is known to be HIV positive
- The subject is known to be Hepatitis B or C positive
- Glycosylated hemoglobin A1C (HbA1C) is > 12%
- Poor nutritional status (albumin < 2.0 g/dL)
- The subject has a history of active, systemic malignancy
- Clinical evidence of bone exposure within the wound bed
- The subject has a history of noncompliance to medical regimens and is not considered reliable
- The subject is unable to understand the study evaluations and provide a written informed consent
Sites / Locations
- Roger Williams Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Placebo Comparator
Sham Comparator
Experimental
Standard therapy and control saline spray
standard therapy and fibrin spray
Conventional standard therapy and MSCs
Conventional standard therapy and control saline spray
Conventional standard therapy and fibrin spray
Conventional Standard Therapy and MSCs (autologous bone marrow-derived mesenchymal stem cells) in fibrin spray.