A Randomized, Double-Blind, Controlled Study to Evaluate the Effectiveness of the Use of Bone Marrow-Derived Mesenchymal Stem Cells (MSCs) in Fibrin in the Treatment of Chronic Wounds
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Wound closure
Study Overview
Brief Summary
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.
Detailed Description
Sixty-six (66) subjects are planned to be enrolled into the trial. each subject's duration of participation will be 24 weeks on therapy with a 4 week post-treatment visit. A run-in phase of 2 weeks will be required prior to randomization/enrollment.
All subjects will receive appropriate and standard care for chronic wounds, including dressings, bandages, and off-loading, if required. All subjects will receive either saline, fibrin or MSCs in fibrin using an identical double-barreled syringe to keep the blind. Therefore, subjects will then be randomized to one of three groups:
- conventional standard therapy and control saline spray
- conventional standard therapy and fibrin spray
- conventional standard therapy and MSCs (autologous bone marrow-derived mesenchymal stem cell)in fibrin spray
Screening Visit:
All inclusion and exclusion information will be reviewed to make sure that the subject is eligible for entry into the study. The following procedures will be performed during this two week period:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Standard therapy and control saline spray
Conventional standard therapy and control saline spray
Intervention: Stem Cell (Genetic)
standard therapy and fibrin spray
Conventional standard therapy and fibrin spray
Intervention: Stem Cell (Genetic)
Conventional standard therapy and MSCs
Conventional Standard Therapy and MSCs (autologous bone marrow-derived mesenchymal stem cells) in fibrin spray.
Intervention: Stem Cell (Genetic)
Outcomes
Primary Outcomes
Wound closure
Time Frame: 24 weeks
Secondary Outcomes
- Overall rate of wound healing reduction(24 weeks)