Healthy VolunteersPhase 1NCT02817984
Safety Study of Acellular Adipose Tissue for Soft Tissue Reconstruction
A Phase 1 study testing Acellular Adipose Tissue (AAT) in people with Healthy Volunteers, run by Johns Hopkins University at 1 site in United States.
Trial summary
The purpose of this study is to assess the safety and tolerability of acellular adipose tissue (AAT), intended for the repair of soft tissue defects in humans, in healthy volunteers. The investigators hypothesize that AAT will be safe and well tolerated upon injection into human soft tissue. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Acellular Adipose Tissue (AAT)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to 6 Apr 2017
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy men and women aged 18-65 years who have sought elective surgery for the removal of redundant tissue of the abdomen (abdominoplasty or panniculectomy) or arm (brachioplasty).
- Willingness to delay elective surgery up to 12 weeks in order to participate in the study.
- Consent to photography for research purposes.
- Willingness to follow study requirements.
- Ability to give informed consent.
- Participants must be willing to perform follow up visits for up to 5 months.
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- Undergo complete blood count (CBC) with Differential and Serum Chemistry. (Results must fall within 1.5 times the normal ranges for all values for candidates to be eligible.)
- Men and Women of reproductive potential: Willingness to use approved methods of birth control or abstain from sexual intercourse from screening until removal of the AAT implants.
- Definition of non-childbearing potential for Women: amenorrhea (previous 12 months) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
- Definition of non-reproductive potential for Men: confirmed surgically sterile (vasectomy >3 months prior to screening).
Who cannot join
- Patients seeking elective surgery for the removal of redundant tissue from areas other than the abdomen or arm.
- Use of AAT in patients exhibiting autoimmune connective tissue disease is not recommended. When applied properly, AAT has been shown to support the migration of host cells from the surrounding tissue. Therefore, this study will exclude patients with conditions that could inhibit migration of host cells including, but not limited to, the following:
- Fever (oral temperature >99º F at time of screening)
- Insulin dependent diabetes
- Low vascularity of the tissue intended for elective excision
- Local or Systemic Infection
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- Mechanical Trauma
- Poor nutrition or general medical condition
- Dehiscence and/or necrosis due to poor revascularization
- Specific or nonspecific immune response to some component of the AAT material
- Infected or nonvascular surgical sites
- Known cancer or receiving treatment for cancer
- Pregnant or Lactating females
- Inability to cooperate with and/or comprehend post-operative instructions
- Inability to speak or read English
- Known allergy or sensitivity to Penicillin, Streptomycin, or Amphotericin B
- Any other reason the study physicians judge would be a contraindication for receiving AAT injections
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
About this study
Official title: A Phase I Open-label Study Evaluating the Safety of Acellular Adipose Tissue (AAT), a Novel Soft Tissue Reconstruction Solution, in Healthy Volunteers
The purpose of this study is to assess the safety and tolerability of acellular adipose tissue (AAT), intended for the repair of soft tissue defects in humans, in healthy volunteers. The investigators hypothesize that AAT will be safe and well tolerated upon injection into human soft tissue.
Read the detailed description
This is a 12-week, prospective, Phase I study in healthy volunteers assessing the safety and tolerability of acellular adipose tissue (AAT) intended for the repair of soft tissue defects in humans. Up to five (5) 2 milliliters (mL) subcutaneous injections of AAT will be administered into redundant tissues previously identified and scheduled for surgical removal in an elective surgical procedure.
Participants will be enrolled and assigned chronologically to one of five excision time points: Weeks 2, 4, 6, 8, and 12 post-injection. Implants will be injected on Day 0. A safety visit will occur at 1 week post-injection; follow-up visits will occur at Weeks 2 and 4 (for patients who still have implants) post-injection and at time of tissue excision. At the end of their assigned study time point, participants will have all AAT implants removed simultaneously during their elective surgery. Implants will be assessed using histopathological analyses including hematoxylin and eosin staining and flow cytometry. The primary outcome of safety will be determined by the incidence and rate of adverse / unanticipated events. Secondary outcomes include histopathological assessment of the explanted implants and tolerability determined by participant-reported comfort and physician-reported ease-of-use with the intervention.
- Conditions
- Healthy Volunteers
- Being tested
- Acellular Adipose Tissue (AAT)
- Keywords
- Abdominoplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acellular Adipose Tissue (AAT)Biological
The components of the adipose-derived scaffold are all naturally occurring AAT proteins and proteoglycans that provide a natural scaffold. The nature of the AAT also enhances host tissue integration since matrix components can be easily degraded by cell-secreted enzymes as tissue remodeling takes place. Mechanisms for matrix turnover are already established in host cells, avoiding any concerns over proper clearance of scaffold materials from the body.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Participants (n=10) will be enrolled and assigned chronologically to one of five excision time points: Weeks 2 (n=10), 4 (n=2), 6 (n=2), 8 (n=2), and 12 (n=2) post-injection. Implants will be injected on Day 0. All participants will be administered up to five (5) 2 milliliter (mL) subcutaneous injections of acellular adipose tissue (AAT) via sterile injection into the area identified for planned excision. Total injected AAT volume per patient will not exceed 10 mL. Receives: Biological: Acellular Adipose Tissue (AAT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of acellular adipose tissue (AAT) injections as determined by the incidence of adverse events
Measured: Up to 12 weeks post-injection
Safety of acellular adipose tissue (AAT) injections as determined by the rate of adverse events
Measured: Up to 12 weeks post-injection
Secondary outcomes (3)
Assess the histopathology of explanted implants via Hematoxylin and eosin (H&E) staining
Measured: Up to 12 weeks post-injection
Assess the histopathology of explanted implants via flow cytometry
Flow cytometry via fluorescence-activated cell sorting (FACS)
Measured: Up to 12 weeks post-injection
Assess tolerability of AAT injections per the participant-reported experience.
Tolerability of AAT injections is assessed through participant-reported comfort questionnaire.
Measured: Up to 12 weeks post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study startApr 2016
- Primary completion6 Apr 2017
- Study completion6 Apr 2017
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 Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command
- Responsible party
- Sponsor
- Investigators
- Jennifer H Elisseeff, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02817984
- Sponsor's protocol ID
- IRB00027657
- Other IDs
- CF-11, 16520
- Status last verified
- Jan 2018
- First submitted
- 21 Jun 2016
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- 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 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Open-label Study Evaluating the Safety of Acellular Adipose Tissue (AAT), a Novel Soft Tissue Reconstruction Solution, in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02817984
- Acronym / sponsor ID
- IRB00027657
- Conditions
- Healthy Volunteers
- Keywords
- Abdominoplasty
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command
- Study start
- Apr 2016 (actual)
- Primary completion
- 6 Apr 2017 (actual)
- Study completion
- 6 Apr 2017 (actual)
- First posted
- 29 Jun 2016 (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.
The purpose of this study is to assess the safety and tolerability of acellular adipose tissue (AAT), intended for the repair of soft tissue defects in humans, in healthy volunteers. The investigators hypothesize that AAT will be safe and well tolerated upon injection into human soft tissue.
Detailed description
This is a 12-week, prospective, Phase I study in healthy volunteers assessing the safety and tolerability of acellular adipose tissue (AAT) intended for the repair of soft tissue defects in humans. Up to five (5) 2 milliliters (mL) subcutaneous injections of AAT will be administered into redundant tissues previously identified and scheduled for surgical removal in an elective surgical procedure.
Participants will be enrolled and assigned chronologically to one of five excision time points: Weeks 2, 4, 6, 8, and 12 post-injection. Implants will be injected on Day 0. A safety visit will occur at 1 week post-injection; follow-up visits will occur at Weeks 2 and 4 (for patients who still have implants) post-injection and at time of tissue excision. At the end of their assigned study time point, participants will have all AAT implants removed simultaneously during their elective surgery. Implants will be assessed using histopathological analyses including hematoxylin and eosin staining and flow cytometry. The primary outcome of safety will be determined by the incidence and rate of adverse / unanticipated events. Secondary outcomes include histopathological assessment of the explanted implants and tolerability determined by participant-reported comfort and physician-reported ease-of-use with the intervention.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Biological: Acellular Adipose Tissue (AAT)Participants (n=10) will be enrolled and assigned chronologically to one of five excision time points: Weeks 2 (n=10), 4 (n=2), 6 (n=2), 8 (n=2), and 12 (n=2) post-injection. Implants will be injected on Day 0. All participants will be administered up to five (5) 2 milliliter (mL) subcutaneous injections of acellular adipose tissue (AAT) via sterile injection into the area identified for planned excision. Total injected AAT volume per patient will not exceed 10 mL. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Healthy men and women aged 18-65 years who have sought elective surgery for the removal of redundant tissue of the abdomen (abdominoplasty or panniculectomy) or arm (brachioplasty).
- Willingness to delay elective surgery up to 12 weeks in order to participate in the study.
- Consent to photography for research purposes.
- Willingness to follow study requirements.
- Ability to give informed consent.
Key exclusion criteria (17 listed)
- Patients seeking elective surgery for the removal of redundant tissue from areas other than the abdomen or arm.
- Use of AAT in patients exhibiting autoimmune connective tissue disease is not recommended. When applied properly, AAT has been shown to support the migration of host cells from the surrounding tissue. Therefore, this study will exclude patients with conditions that could inhibit migration of host cells including, but not limited to, the following:
- Pregnant or Lactating females
- Inability to cooperate with and/or comprehend post-operative instructions
- Inability to speak or read English
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 |
|---|---|---|
| Acellular Adipose Tissue (AAT)The components of the adipose-derived scaffold are all naturally occurring AAT proteins and proteoglycans that provide a natural scaffold. The nature of the AAT also enhances host tissue integration since matrix components can be easily degraded by cell-secreted enzymes as tissue remodeling takes place. Mechanisms for matrix turnover are already established in host cells, avoiding any concerns over proper clearance of scaffold materials from the body. | Biological | Treatment Group |
Primary outcome
Safety of acellular adipose tissue (AAT) injections as determined by the incidence of adverse events
Time frame: Up to 12 weeks post-injection
Safety of acellular adipose tissue (AAT) injections as determined by the rate of adverse events
Time frame: Up to 12 weeks post-injection
3 secondary outcomes
Assess the histopathology of explanted implants via Hematoxylin and eosin (H&E) staining
Time frame: Up to 12 weeks post-injection
Assess the histopathology of explanted implants via flow cytometry
Time frame: Up to 12 weeks post-injection
Assess tolerability of AAT injections per the participant-reported experience.
Time frame: Up to 12 weeks post-injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
- 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.
- Individual participant dataSharing planned: Yes
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Screening Protocol
Pain
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.
Jennifer H Elisseeff, PhD principal investigator
Johns Hopkins University
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 Acellular Adipose Tissue (AAT) in people with Healthy Volunteers, run by Johns Hopkins University 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 10 inclusion and 17 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: finished, as of the sponsor's last update on 25 Jan 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of acellular adipose tissue (AAT) injections as determined by the incidence of adverse events (time frame: Up to 12 weeks post-injection). The study lists 2 primary outcomes in all. 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 NCT02817984, 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 Jan 2018.