Study of the Effectiveness of Autologous Bone Marrow-Derived Mesenchymal Stem Cells in Fibrin to Treat Chronic Wounds
Stopped early · Phase 1
Conditions studied: Non Healing Wounds
In brief
The purpose of this study is to determine the effectiveness of Autologous Bone Marrow-Derived Mesenchymal Stem Cells (MSCs) in the treatment of non-healing wounds.
Key facts
- Study ID
- NCT01751282
- Run by
- Roger Williams Medical Center
- People needed
- 5
- Starts
- 2010-06-01
- Expected to finish
- 2015-06-01
- Last updated by the study team
- 2016-10-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Roger Williams Medical Center — Providence, Rhode Island, United States
Full record on ClinicalTrials.gov
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