Disorder of Soft Tissue of Body Wall RegionPhase 1NCT01992315
Investigation of A-ECM for the Correction of Soft Tissue Defects
A Phase 1 study testing Adipose-derived ECM in people with Disorder of Soft Tissue of Body Wall Region, run by Aegeria Soft Tissue LLC at 1 site in United States.
Trial summary
Soft tissue injury leads to significant deformity in size, shape and body contour. Adipose tissue, continues to be the tissue of choice in repairing soft tissue defects due to traumatic or other defects. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Disorder of Soft Tissue of Body Wall Region
- What is being tested?
- Adipose-derived ECM
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Aug 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women, ages 20-50, with previous congenital or acquired soft tissue deformities of the body or face that are willing to have photographs taken may join this study
Who cannot join
- pregnant women, patients with known immunocompromise or wound healing disorders
Trial locations and contacts
1 site in 1 country.
United States1 site
Cosmetic Surgery Center of Maryland
Towson, Maryland, 21204
Nancy Teasley, 410-296-0414, Nancy Teasley <wateas@verizon.net>
Amit Kochhar, MD, 3057101130, akochha4@jhmi.edu
About this study
Official title: Investigation of Decellularized Adipose Derived-ECM for the Correction of Acquired Soft Tissue Deformities of the Body and Face
Soft tissue injury leads to significant deformity in size, shape and body contour. Adipose tissue, continues to be the tissue of choice in repairing soft tissue defects due to traumatic or other defects. Current autologous fat transfer techniques, however, have a number of limitations including significant donor site morbidity, unpredictable resorption, and the potential for requiring revision. Thus, an "off-the-shelf" material that retains the mechanical and biological properties of adipose tissue would be ideal for the reconstruction.
Extracellular matrix (ECM)-based biomaterials have the potential to be a non-immunogenic biological scaffold for adipose tissue engineering for repair of soft tissue defects. Our collaborators have recently generated a novel tissue-derived material to improve soft tissue reconstruction. The final, processed adipose tissue does not contain cellular components, yet retains the native architecture and bioactivity of the original adipose tissue. The tissue is then further processed into particles to create an injectable implant. In preclinical models, we have demonstrated that human adipose tissue can be decellularized by mechanical processing with preservation of matrix ultrastructure. Histologic analysis two-weeks after implantation into rats showed minimal inflammatory reaction and good tissue integration of the decellularized, dilipidized, adipose derived-ECM.
The goal of the study is to 1) evaluate the safety and compatibility of the soft tissue implant, and 2) determine the efficacy of this ECM replacement in soft tissue injuries after 6 weeks. Specifically, the volume of the soft tissue defect will be determined before implantation and at multiple time points over the following 6 weeks. We hypothesize that the decellularized adipose ECM will retain at least 50% volume and surface area after 6 weeks. If our results are promising, decellularized adipose derived-ECM may be a viable alternative to autologous tissue transplantation for correction of soft tissue deformity.
- Being tested
- Adipose-derived ECM
- Keywords
- Scar, Soft tissue defect
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adipose-derived ECMDevice
Each syringe of adipose-derived ECM will hold 2mL and will be for single use only. Up to 3 syringes (6mL total) may be used for each patient. Injections will be made under local anesthesia and sterile conditions using a 23-gauge needle. All injections will be performed in an outpatient clinic setting at study site by the principal investigator who will determine the method, depth, and volume of each implant. Decellularized adipose tissue-derived matrix will be infiltrated into the defect and the underlying musculature as well as the subcutaneous tissue surrounding the defect, with the goal of creating a smooth transition from surrounding structures to the filled defect. This will be performed using a series of multiple punctures or a single puncture with a fanning or threading technique. After the injection is completed, the treatment area will be massaged to conform to the contour of the surrounding tissue and ice will be applied as needed for swelling.
| Study group | Role | What they receive |
|---|---|---|
| Adipose-Derived ECM | Experimental | Not described Receives: Device: Adipose-derived ECM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical assessment of toxicity associated with soft tissue injection of Adipose-derived ECM
At each post-injection visit, week 1, 4, and 6, the principal investigator will examine patients for presence of adverse events such as toxicity, pain/inflammation at the site of injection
Measured: 6 weeks
Secondary outcomes (1)
Objective assessment of volume retention following soft tissue injection of Adipose-derived ECM
At each visit, week 1, 4, and 6, 3-D photography will be performed to assess volume retention
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startMar 2014
- Primary completionJun 2015 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Disorder of Soft Tissue of Body Wall RegionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aegeria Soft Tissue LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Larry Lickstein, MD, Principal investigator, Cosmetic Surgery Center of Maryland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01992315
- Sponsor's protocol ID
- AST Adipose ECM
- Status last verified
- Nov 2013
- First submitted
- 14 Nov 2013
- Last updated
- 25 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wu I, Nahas Z, Kimmerling KA, Rosson GD, Elisseeff JH. An injectable adipose matrix for soft-tissue reconstruction. Plast Reconstr Surg. 2012 Jun;129(6):1247-1257. doi: 10.1097/PRS.0b013e31824ec3dc.
PubMed 22327888
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Decellularized Adipose Derived-ECM for the Correction of Acquired Soft Tissue Deformities of the Body and Face
- ClinicalTrials.gov ID
- NCT01992315
- Acronym / sponsor ID
- AST Adipose ECM
- Keywords
- Scar, Soft tissue defect
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Aegeria Soft Tissue LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Soft tissue injury leads to significant deformity in size, shape and body contour. Adipose tissue, continues to be the tissue of choice in repairing soft tissue defects due to traumatic or other defects. Current autologous fat transfer techniques, however, have a number of limitations including significant donor site morbidity, unpredictable resorption, and the potential for requiring revision. Thus, an "off-the-shelf" material that retains the mechanical and biological properties of adipose tissue would be ideal for the reconstruction.
Extracellular matrix (ECM)-based biomaterials have the potential to be a non-immunogenic biological scaffold for adipose tissue engineering for repair of soft tissue defects. Our collaborators have recently generated a novel tissue-derived material to improve soft tissue reconstruction. The final, processed adipose tissue does not contain cellular components, yet retains the native architecture and bioactivity of the original adipose tissue. The tissue is then further processed into particles to create an injectable implant. In preclinical models, we have demonstrated that human adipose tissue can be decellularized by mechanical processing with preservation of matrix ultrastructure. Histologic analysis two-weeks after implantation into rats showed minimal inflammatory reaction and good tissue integration of the decellularized, dilipidized, adipose derived-ECM.
The goal of the study is to 1) evaluate the safety and compatibility of the soft tissue implant, and 2) determine the efficacy of this ECM replacement in soft tissue injuries after 6 weeks. Specifically, the volume of the soft tissue defect will be determined before implantation and at multiple time points over the following 6 weeks. We hypothesize that the decellularized adipose ECM will retain at least 50% volume and surface area after 6 weeks. If our results are promising, decellularized adipose derived-ECM may be a viable alternative to autologous tissue transplantation for correction of soft tissue deformity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adipose-Derived ECM | Experimental | Device: Adipose-derived ECM |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Men and women, ages 20-50, with previous congenital or acquired soft tissue deformities of the body or face that are willing to have photographs taken may join this study
Key exclusion criteria (1 listed)
- pregnant women, patients with known immunocompromise or wound healing disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adipose-derived ECMEach syringe of adipose-derived ECM will hold 2mL and will be for single use only. Up to 3 syringes (6mL total) may be used for each patient. Injections will be made under local anesthesia and sterile conditions using a 23-gauge needle. All injections will be performed in an outpatient clinic setting at study site by the principal investigator who will determine the method, depth, and volume of each implant. Decellularized adipose tissue-derived matrix will be infiltrated into the defect and the underlying musculature as well as the subcutaneous tissue surrounding the defect, with the goal of creating a smooth transition from surrounding structures to the filled defect. This will be performed using a series of multiple punctures or a single puncture with a fanning or threading technique. After the injection is completed, the treatment area will be massaged to conform to the contour of the surrounding tissue and ice will be applied as needed for swelling. | Device | Adipose-Derived ECM |
Primary outcome
Clinical assessment of toxicity associated with soft tissue injection of Adipose-derived ECM
Time frame: 6 weeks
At each post-injection visit, week 1, 4, and 6, the principal investigator will examine patients for presence of adverse events such as toxicity, pain/inflammation at the site of injection
1 secondary outcome
Objective assessment of volume retention following soft tissue injection of Adipose-derived ECM
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2013.
- Background: PubMed 22327888Wu I, Nahas Z, Kimmerling KA, Rosson GD, Elisseeff JH. An injectable adipose matrix for soft-tissue reconstruction. Plast Reconstr Surg. 2012 Jun;129(6):1247-1257. doi: 10.1097/PRS.0b013e31824ec3dc.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Larry Lickstein, MD principal investigator
Cosmetic Surgery Center of Maryland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Adipose-derived ECM in people with Disorder of Soft Tissue of Body Wall Region, run by Aegeria Soft Tissue LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nancy Teasley, RN ((410) 296-0414, Nancy Teasley <wateas@verizon.net>), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical assessment of toxicity associated with soft tissue injection of Adipose-derived ECM (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01992315, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2013.