Back to resultsAdipose-Derived Stromal Cells (ASC's) for Pressure Ulcers
Primary Purpose
Pressure Ulcer
Status
Enrolling by invitation
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Adipose-derived stromal cells
Adipose-derived stromal cells
Sponsored by
About this trial
This is an interventional treatment trial for Pressure Ulcer focused on measuring Stem cells
Eligibility Criteria
Inclusion Criteria
- Males and females
- Stage III pressure ulcers measuring 5 cc - 36 cc in volume (as measured by filling the wound with Normal Saline).
- Inpatient or outpatient treatment of pressure ulcers
- Diabetic Foot Ulcer Stage 1 or 2 of any size
Co-morbidities may include:
- Peripheral Vascular Disease (PVD)
- Coronary Artery Disease (CAD)
- Chronic Renal Disease (CRD)
- Chronic Liver Disease (CLD)
- Hypertension (HTN)
- Diabetes
- The ability of subjects to give appropriate consent or have an appropriate representative available to do so
- The ability of subjects to return for weekly wound assessments
Exclusion Criteria
- Patients with allergies to TISSEEL, Tegaderm, or silicon
- Diabetics with poor glucose metabolic control (HbA1c > 9)
- Target wounds that are in close proximity to potential cancerous lesions
- Patients who require Negative Pressure Wound Therapy (NPWT), limb amputation, or surgical intervention at the target wound at the time of screening
- Wounds located on the face
- Patients with Stage 5 or 6 Peripheral Vascular disease (specifically, wounds that are caused by peripheral vascular disease such as leg ulcers)
- Wounds caused by diabetes mellitus (diabetic foot ulcers).
- BMI of <16 Clinical signs of critical colonization or local infection
- Prolonged (> 6 months) use of steroids
- Patients on active regimen of chemotherapy
- Patients receiving radiation in proximity of wound
- Decompensated chronic liver disease
Sites / Locations
- Mayo Clinic in Florida
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental
Arm Description
Liposuction will be done to extract 50-100 cc of adipose tissue which will be processed to obtain the stromal cells. The adipose-derived stromal cells will be injected into a fibrin sealant applicator and applied to the wound (intervention), Patients will receive 5.0x106 ASCs per cubic centimeter of wound area. The wound will be dressed with an occlusive dressing and soft silicone dressing. The dressing will remain in place for one week (minimally, 3 days). Follow-up will occur weekly for 6 weeks.
Outcomes
Primary Outcome Measures
Free of wound infection
Symptoms include fever along with new or increasing pain, erythema, local warmth, swelling, purulent discharge, and/or malodor
Secondary Outcome Measures
Liposuction procedure without complication
Signs of adverse reactions to the liposuction procedure include an allergy to the Hunstad solution, infection at the puncture wound site or risk of bleeding at the puncture wound site. Risks include bleeding or infection at the site and bruising for approximately one week. No adverse consequences of fluid overload have been associated with low volume liposuction.
Improved wound healing
Wound healing is greater than 20% healing within two weeks documented by measurement of the wound bed or wound healing to less than the dermal layer documented by photography and agreement of healing between research nurse and wound physician consultant. Would not expect deterioration to a more severe level of tissue injury
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02375802
Brief Title
Adipose-Derived Stromal Cells (ASC's) for Pressure Ulcers
Official Title
A Pilot Study: Evaluating the Safety and Feasibility of Using Autologous Adipose-Derived Stromal Cells From Stromal Vascular Fraction (SVF) on Adults With Pressure Ulcers or Diabetic Foot Ulcers
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 2015 (undefined)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This pilot study of 12 patients will test the safety and efficacy of applying autologous, adipose-derived stromal cells (ASCs), uncultured, on a Stage III or IV pressure ulcer or diabetic foot ulcers. Patients will undergo a minimal risk liposuction procedure to withdraw 50-100 cc of adipose tissue. The tissue would be processed to extract the stromal layer of cells that contain stem cells. The ASCs would be injected into a fibrin sealant to be applied to the wound. Patients would be followed for 6 weeks to assess wound healing and tolerance of the treatment.
Detailed Description
Wound healing for Stage III and IV pressure ulcers or diabetic foot ulcers can take four to six weeks or longer and cost upwards of $40,000 to treat. Past studies have shown that adipose tissue contains progenitor cells or regenerative cells that can release multiple angiogenic growth factors and cytokines including vascular endothelial growth factor (VEGF), hepatocyte growth factor (HGF) and chemokine stromal cell-derived factor-1 (SDF-1). A current literature review revealed that there is research related to use of stem cells to enhance wound healing, in particular with ischemic or radiation-induced ulcers. However, there is limited research completed on use of stem cells or ASCs with pressure ulcers. The goal is to heal pressure ulcers faster and prevent further complications using the patient's own natural ASCs.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcer
Keywords
Stem cells
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Liposuction will be done to extract 50-100 cc of adipose tissue which will be processed to obtain the stromal cells. The adipose-derived stromal cells will be injected into a fibrin sealant applicator and applied to the wound (intervention), Patients will receive 5.0x106 ASCs per cubic centimeter of wound area. The wound will be dressed with an occlusive dressing and soft silicone dressing. The dressing will remain in place for one week (minimally, 3 days). Follow-up will occur weekly for 6 weeks.
Intervention Type
Biological
Intervention Name(s)
Adipose-derived stromal cells
Other Intervention Name(s)
ASC's
Intervention Description
Adipose-derived stromal cells contain stem cells which have been successful in enhancing wound healing. The product used as the carrier is a fibrin sealant called TISSEEL. Pre-pilot testing was done to verify viability of the stromal cells for up to 72 hours in the fibrin sealant.
Intervention Type
Drug
Intervention Name(s)
Adipose-derived stromal cells
Primary Outcome Measure Information:
Title
Free of wound infection
Description
Symptoms include fever along with new or increasing pain, erythema, local warmth, swelling, purulent discharge, and/or malodor
Time Frame
one week
Secondary Outcome Measure Information:
Title
Liposuction procedure without complication
Description
Signs of adverse reactions to the liposuction procedure include an allergy to the Hunstad solution, infection at the puncture wound site or risk of bleeding at the puncture wound site. Risks include bleeding or infection at the site and bruising for approximately one week. No adverse consequences of fluid overload have been associated with low volume liposuction.
Time Frame
one week
Title
Improved wound healing
Description
Wound healing is greater than 20% healing within two weeks documented by measurement of the wound bed or wound healing to less than the dermal layer documented by photography and agreement of healing between research nurse and wound physician consultant. Would not expect deterioration to a more severe level of tissue injury
Time Frame
weekly observation for 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Males and females
Stage III pressure ulcers measuring 5 cc - 36 cc in volume (as measured by filling the wound with Normal Saline).
Inpatient or outpatient treatment of pressure ulcers
Diabetic Foot Ulcer Stage 1 or 2 of any size
Co-morbidities may include:
Peripheral Vascular Disease (PVD)
Coronary Artery Disease (CAD)
Chronic Renal Disease (CRD)
Chronic Liver Disease (CLD)
Hypertension (HTN)
Diabetes
The ability of subjects to give appropriate consent or have an appropriate representative available to do so
The ability of subjects to return for weekly wound assessments
Exclusion Criteria
Patients with allergies to TISSEEL, Tegaderm, or silicon
Diabetics with poor glucose metabolic control (HbA1c > 9)
Target wounds that are in close proximity to potential cancerous lesions
Patients who require Negative Pressure Wound Therapy (NPWT), limb amputation, or surgical intervention at the target wound at the time of screening
Wounds located on the face
Patients with Stage 5 or 6 Peripheral Vascular disease (specifically, wounds that are caused by peripheral vascular disease such as leg ulcers)
Wounds caused by diabetes mellitus (diabetic foot ulcers).
BMI of <16 Clinical signs of critical colonization or local infection
Prolonged (> 6 months) use of steroids
Patients on active regimen of chemotherapy
Patients receiving radiation in proximity of wound
Decompensated chronic liver disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Houssam Farres, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22732376
Citation
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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Links:
URL
http://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Adipose-Derived Stromal Cells (ASC's) for Pressure Ulcers
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