Soft Tissue InjuriesPhase 2NCT03544632
Acellular Adipose Tissue (AAT) for Soft Tissue Reconstruction
A Phase 2 study testing Acellular Adipose Tissue (AAT) in people with Soft Tissue Injuries and Trauma, run by Johns Hopkins University at 1 site in United States.
Trial summary
Although other methods (e.g., autologous fat transfer, dermal-/collagen-based fillers) for soft tissue reconstruction exist, each has distinct disadvantages leaving room for improvement in this treatment area. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Soft Tissue Injuries, Trauma
- 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
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2018to 28 Feb 2026
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged 18-65 years with at least one modest (5-30cc) soft tissue defect on the trunk and
- Willingness to wait up to 6 months to participate in the study (depending on defect size and enrollment-to-date).
- Consent to photography for research purposes.
- Willingness to follow study requirements.
- Ability to give informed consent.
- Willingness to perform follow up visits for 12 months (+/- 30 days).
Show all 10Show fewer
- Willingness to undergo complete blood count (CBC) with Differential and Serum Chemistry.
- For Men and Women of reproductive potential: Willingness to use approved methods of birth control or abstain from sexual intercourse from screening until 6 months post-AAT injection.
- 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
- 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
- Mechanical Trauma
Show all 17Show fewer
- 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
- Also:
- 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 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 II, Dose-escalation, Open-label Study Evaluating the Safety and Efficacy of Permanently-placed Acellular Adipose Tissue (AAT) in Human Subjects With Modest Soft Tissue Defects of the Trunk
Although other methods (e.g., autologous fat transfer, dermal-/collagen-based fillers) for soft tissue reconstruction exist, each has distinct disadvantages leaving room for improvement in this treatment area. Investigators in the Elisseeff Laboratory (Johns Hopkins University Department of Biomedical Engineering) have recently generated a novel tissue-derived material to create instructive matrices for soft tissue reconstruction called Acellular Adipose Tissue (AAT). This material takes advantage of the inherent bioactivity and unique mechanical properties of subcutaneous adipose tissue. Investigators' preclinical data suggest that AAT is safe for use in small and large animals; investigators' clinical (Phase I) data suggest that AAT is safe for use in humans. These data indicate that a Phase II, dose-escalation study of AAT's safety and efficacy in human subjects is warranted.
Read the detailed description
Soft tissue volume loss acquired through trauma, congenital malformation or comorbid conditions (i.e., HIV/AIDS) is a common and sometimes devastating problem. Traditional therapies include local tissue transfer, allograft placement, and complex scar revision techniques. Recently, autologous fat transfer has become one of the most commonly employed techniques for improving soft tissue contour deformity particularly for the correction of breast and body defects. While the results from this procedure continue to improve, it requires an additional procedure to harvest fat tissue from the abdomen, thigh or flank leading to donor site morbidity. Clinically, volume loss following autologous fat transfer has been reported to be between 40-60% and usually occurs within the first 4-6 months. Regrafting is often needed and implanted adipose tissue frequently leads to post-operative calcifications. For these reasons, a predictable, "off-the-shelf" material that retains the mechanical and biological properties of adipose tissue would be ideal for the reconstruction of smaller soft tissue defects and soft tissue augmentation.
Investigators in the Elisseeff Laboratory (Johns Hopkins University Department of Biomedical Engineering) generated a novel tissue-derived material to create instructive matrices for soft tissue reconstruction [Acellular Adipose Tissue (AAT)]. In 2016, investigators conducted a Phase 1, open-label, clinical trial of AAT in healthy volunteers who planned to have elective surgery for the removal of redundant tissue (n=8). Overall, AAT demonstrated satisfactory safety results. No participants experienced serious adverse events (SAEs) or unanticipated adverse events (AEs) related to the study, or exited the study due to AEs. All AEs noted were expected and mild, including redness, bruising, textural changes, hyperpigmentation and tenderness at the injection site. Many other adverse events commonly associated with injections were not observed in any participant throughout the study (i.e., scarring, ulceration, scabbing, purpura, oozing, crusting, blanching, blistering, edema or abrasions). These data indicate that conducting a phase II, dose-escalation, safety and efficacy study in humans is warranted. Based on investigators' experience, investigators hypothesize that AAT will be safe and maintain its volume up to 6 months when injected subcutaneously to restore 5-20cc defects in human soft tissue.
- Conditions
- Soft Tissue Injuries, Trauma
- Being tested
- Acellular Adipose Tissue (AAT)
- Keywords
- adipose-derived extracellular matrix (ECM), acellular adipose tissue (AAT)
- Medical subject headings
- Soft Tissue Injuries, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acellular Adipose Tissue (AAT)Drug
Participants (n=15) will be administered between 5cc and 20cc of AAT, depending on their assigned treatment group, via sterile subcutaneous injection into the target defect. The injection is intended to be permanent. After the 3-month study follow-up visit, participants will have the option to undergo additional AAT injection (up to 20cc per treatment) in order to fully correct the defect. Total injected AAT volume per patient will not exceed 40cc. Additional injection is dependent upon study- and patient-specific adverse / unanticipated events to date.
Each vial contains a 2 milliliter (mL) dose of the injectable AAT. This volume is similar to other commonly used injectable filler materials intended for soft tissue correction.
| Study group | Role | What they receive |
|---|---|---|
| Acellular Adipose Tissue (AAT) | Experimental | This open-label, phase II, dose-escalation study will be conducted in human subjects seeking repair of modest (approx. 5-30cc) soft tissue defects of the trunk (n=15). All participants will be treated via permanent injection of the study intervention (AAT injection) to restore the defect's contour. All study data will be collected in Case Report Forms (CRFs) and entered into a customized study database, created and maintained in HIPAA-compliant Research Electronic Data Capture (REDCap) software (14). Receives: Drug: Acellular Adipose Tissue (AAT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
AAT efficacy for soft-tissue reconstruction - Volume Retention
Volume retention documented by pre-to-post injection volumetric changes as detected by 3-dimensional photography
Measured: 6 months post-final injection
AAT efficacy for soft-tissue reconstruction - blinded assessors
Assessments to determine aesthetic appearance of defects documented by blinded assessors rating defect sites using the Global Aesthetic Improvement Scale (GAIS). 5 point scale ranging from 1 to 5 with 5 = The appearance has worsened compared with the original condition and 1 = Excellent corrective results
Measured: 6 months post-final injection
AAT efficacy for soft-tissue reconstruction - patient-reported
Post-injection assessment to determine aesthetic outcome documented by patient-reported satisfaction with the repair
Measured: 6 months post-final injection
Secondary outcomes (3)
Histopathological analysis of explanted implants
Histopathology will be performed on core needle biopsy samples collected at 3, 6, 9, and 12 months post-injection and will be done using the following: H\&E staining to assess (1) native cellular infiltration of the implant, (2) location of implant relative to dermis/subdermis, (3) inflammatory response to implant, and (4) presence of fibrosis
Measured: up to 12 months post-injection
Physician Ease of Use Assessments
Physician ease of use will be measured through the completion of self-administered surveys by the study surgeon.
Measured: up to 12 months post-injection
Participant Comfort Surveys
Participant comfort will be measured through the completion of self-administered surveys by the participant.
Measured: up to 12 months post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2018
- Study start21 Jun 2018
- Primary completion28 Feb 2026
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Soft Tissue InjuriesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 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, Armed Forces Institute of Regenerative Medicine
- Responsible party
- Sponsor
- Investigators
- Damon Cooney, MD, PhD, Principal investigator, The Department of Plastic and Reconstructive Surgery, Johns Hopkins University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03544632
- Sponsor's protocol ID
- IRB00155003
- Status last verified
- May 2026
- First submitted
- 25 Apr 2018
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bucky LP, Percec I. The science of autologous fat grafting: views on current and future approaches to neoadipogenesis. Aesthet Surg J. 2008 May-Jun;28(3):313-21; quiz 322-4. doi: 10.1016/j.asj.2008.02.004.
PubMed 19083543Wan DC, Lim AT, Longaker MT. Craniofacial autologous fat transfer. J Craniofac Surg. 2009 Mar;20(2):273-4. doi: 10.1097/SCS.0b013e31819921d3. No abstract available.
PubMed 19305242Cordeiro PG. Breast reconstruction after surgery for breast cancer. N Engl J Med. 2008 Oct 9;359(15):1590-601. doi: 10.1056/NEJMct0802899. No abstract available.
PubMed 18843123Rosson GD, Magarakis M, Shridharani SM, Stapleton SM, Jacobs LK, Manahan MA, Flores JI. A review of the surgical management of breast cancer: plastic reconstructive techniques and timing implications. Ann Surg Oncol. 2010 Jul;17(7):1890-900. doi: 10.1245/s10434-010-0913-7. Epub 2010 Mar 9.
PubMed 20217253Pulagam SR, Poulton T, Mamounas EP. Long-term clinical and radiologic results with autologous fat transplantation for breast augmentation: case reports and review of the literature. Breast J. 2006 Jan-Feb;12(1):63-5. doi: 10.1111/j.1075-122X.2006.00188.x.
PubMed 16409589Cheng MH, Uriel S, Moya ML, Francis-Sedlak M, Wang R, Huang JJ, Chang SY, Brey EM. Dermis-derived hydrogels support adipogenesis in vivo. J Biomed Mater Res A. 2010 Mar 1;92(3):852-8. doi: 10.1002/jbm.a.32410.
PubMed 19280638Uriel S, Huang JJ, Moya ML, Francis ME, Wang R, Chang SY, Cheng MH, Brey EM. The role of adipose protein derived hydrogels in adipogenesis. Biomaterials. 2008 Sep;29(27):3712-3719. doi: 10.1016/j.biomaterials.2008.05.028. Epub 2008 Jun 24.
PubMed 18571717Wu 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 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Dose-escalation, Open-label Study Evaluating the Safety and Efficacy of Permanently-placed Acellular Adipose Tissue (AAT) in Human Subjects With Modest Soft Tissue Defects of the Trunk
- ClinicalTrials.gov ID
- NCT03544632
- Acronym / sponsor ID
- IRB00155003
- Conditions
- Soft Tissue Injuries, Trauma
- Keywords
- adipose-derived extracellular matrix (ECM), acellular adipose tissue (AAT)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command, Armed Forces Institute of Regenerative Medicine
- Study start
- 21 Jun 2018 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 4 Jun 2018 (actual)
- 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.
Although other methods (e.g., autologous fat transfer, dermal-/collagen-based fillers) for soft tissue reconstruction exist, each has distinct disadvantages leaving room for improvement in this treatment area. Investigators in the Elisseeff Laboratory (Johns Hopkins University Department of Biomedical Engineering) have recently generated a novel tissue-derived material to create instructive matrices for soft tissue reconstruction called Acellular Adipose Tissue (AAT). This material takes advantage of the inherent bioactivity and unique mechanical properties of subcutaneous adipose tissue. Investigators' preclinical data suggest that AAT is safe for use in small and large animals; investigators' clinical (Phase I) data suggest that AAT is safe for use in humans. These data indicate that a Phase II, dose-escalation study of AAT's safety and efficacy in human subjects is warranted.
Detailed description
Soft tissue volume loss acquired through trauma, congenital malformation or comorbid conditions (i.e., HIV/AIDS) is a common and sometimes devastating problem. Traditional therapies include local tissue transfer, allograft placement, and complex scar revision techniques. Recently, autologous fat transfer has become one of the most commonly employed techniques for improving soft tissue contour deformity particularly for the correction of breast and body defects. While the results from this procedure continue to improve, it requires an additional procedure to harvest fat tissue from the abdomen, thigh or flank leading to donor site morbidity. Clinically, volume loss following autologous fat transfer has been reported to be between 40-60% and usually occurs within the first 4-6 months. Regrafting is often needed and implanted adipose tissue frequently leads to post-operative calcifications. For these reasons, a predictable, "off-the-shelf" material that retains the mechanical and biological properties of adipose tissue would be ideal for the reconstruction of smaller soft tissue defects and soft tissue augmentation.
Investigators in the Elisseeff Laboratory (Johns Hopkins University Department of Biomedical Engineering) generated a novel tissue-derived material to create instructive matrices for soft tissue reconstruction [Acellular Adipose Tissue (AAT)]. In 2016, investigators conducted a Phase 1, open-label, clinical trial of AAT in healthy volunteers who planned to have elective surgery for the removal of redundant tissue (n=8). Overall, AAT demonstrated satisfactory safety results. No participants experienced serious adverse events (SAEs) or unanticipated adverse events (AEs) related to the study, or exited the study due to AEs. All AEs noted were expected and mild, including redness, bruising, textural changes, hyperpigmentation and tenderness at the injection site. Many other adverse events commonly associated with injections were not observed in any participant throughout the study (i.e., scarring, ulceration, scabbing, purpura, oozing, crusting, blanching, blistering, edema or abrasions). These data indicate that conducting a phase II, dose-escalation, safety and efficacy study in humans is warranted. Based on investigators' experience, investigators hypothesize that AAT will be safe and maintain its volume up to 6 months when injected subcutaneously to restore 5-20cc defects in human soft tissue.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acellular Adipose Tissue (AAT) | Experimental | Drug: Acellular Adipose Tissue (AAT)This open-label, phase II, dose-escalation study will be conducted in human subjects seeking repair of modest (approx. 5-30cc) soft tissue defects of the trunk (n=15). All participants will be treated via permanent injection of the study intervention (AAT injection) to restore the defect's contour. All study data will be collected in Case Report Forms (CRFs) and entered into a customized study database, created and maintained in HIPAA-compliant Research Electronic Data Capture (REDCap) software (14). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Men and women aged 18-65 years with at least one modest (5-30cc) soft tissue defect on the trunk and
- Willingness to wait up to 6 months to participate in the study (depending on defect size and enrollment-to-date).
- Consent to photography for research purposes.
- Willingness to follow study requirements.
- Ability to give informed consent.
Key exclusion criteria (17 listed)
- 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
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)Participants (n=15) will be administered between 5cc and 20cc of AAT, depending on their assigned treatment group, via sterile subcutaneous injection into the target defect. The injection is intended to be permanent. After the 3-month study follow-up visit, participants will have the option to undergo additional AAT injection (up to 20cc per treatment) in order to fully correct the defect. Total injected AAT volume per patient will not exceed 40cc. Additional injection is dependent upon study- and patient-specific adverse / unanticipated events to date. Each vial contains a 2 milliliter (mL) dose of the injectable AAT. This volume is similar to other commonly used injectable filler materials intended for soft tissue correction. | Drug | Acellular Adipose Tissue (AAT) |
Primary outcome
AAT efficacy for soft-tissue reconstruction - Volume Retention
Time frame: 6 months post-final injection
Volume retention documented by pre-to-post injection volumetric changes as detected by 3-dimensional photography
AAT efficacy for soft-tissue reconstruction - blinded assessors
Time frame: 6 months post-final injection
Assessments to determine aesthetic appearance of defects documented by blinded assessors rating defect sites using the Global Aesthetic Improvement Scale (GAIS). 5 point scale ranging from 1 to 5 with 5 = The appearance has worsened compared with the original condition and 1 = Excellent corrective results
AAT efficacy for soft-tissue reconstruction - patient-reported
Time frame: 6 months post-final injection
Post-injection assessment to determine aesthetic outcome documented by patient-reported satisfaction with the repair
3 secondary outcomes
Histopathological analysis of explanted implants
Time frame: up to 12 months post-injection
Physician Ease of Use Assessments
Time frame: up to 12 months post-injection
Participant Comfort Surveys
Time frame: up to 12 months 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 12 May 2026.
- Background: PubMed 19083543Bucky LP, Percec I. The science of autologous fat grafting: views on current and future approaches to neoadipogenesis. Aesthet Surg J. 2008 May-Jun;28(3):313-21; quiz 322-4. doi: 10.1016/j.asj.2008.02.004.
- Background: PubMed 19305242Wan DC, Lim AT, Longaker MT. Craniofacial autologous fat transfer. J Craniofac Surg. 2009 Mar;20(2):273-4. doi: 10.1097/SCS.0b013e31819921d3. No abstract available.
- Background: PubMed 18843123Cordeiro PG. Breast reconstruction after surgery for breast cancer. N Engl J Med. 2008 Oct 9;359(15):1590-601. doi: 10.1056/NEJMct0802899. No abstract available.
- Background: PubMed 20217253Rosson GD, Magarakis M, Shridharani SM, Stapleton SM, Jacobs LK, Manahan MA, Flores JI. A review of the surgical management of breast cancer: plastic reconstructive techniques and timing implications. Ann Surg Oncol. 2010 Jul;17(7):1890-900. doi: 10.1245/s10434-010-0913-7. Epub 2010 Mar 9.
- Background: PubMed 16409589Pulagam SR, Poulton T, Mamounas EP. Long-term clinical and radiologic results with autologous fat transplantation for breast augmentation: case reports and review of the literature. Breast J. 2006 Jan-Feb;12(1):63-5. doi: 10.1111/j.1075-122X.2006.00188.x.
- Background: PubMed 19280638Cheng MH, Uriel S, Moya ML, Francis-Sedlak M, Wang R, Huang JJ, Chang SY, Brey EM. Dermis-derived hydrogels support adipogenesis in vivo. J Biomed Mater Res A. 2010 Mar 1;92(3):852-8. doi: 10.1002/jbm.a.32410.
- Background: PubMed 18571717Uriel S, Huang JJ, Moya ML, Francis ME, Wang R, Chang SY, Cheng MH, Brey EM. The role of adipose protein derived hydrogels in adipogenesis. Biomaterials. 2008 Sep;29(27):3712-3719. doi: 10.1016/j.biomaterials.2008.05.028. Epub 2008 Jun 24.
- 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.
- Safety Study of Acellular Adipose Tissue for Soft Tissue ReconstructionLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Soft Tissue Injuries
Recruiting
Monitored Anesthesia Care and Soft Tissue Infiltration With Local Anesthesia Feasibility Trial
Hip Fracture Surgeries, Intertrochanteric Fracture
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Comparing Cross-Linked and Non-Cross-Linked Hyaluronic Acid for Early Healing After Tooth Extraction
Wound Healing After Tooth Extraction
RecruitingPhase 2/3
Lactoferrin Nanohydrogel for Soft And Hard Tissue Healing and Implant Stability in Immediate Implant Placement
Dental Implant, Wound Healing
Recruiting
Irrigating vs Traditional Negative Pressure Wound Therapy to Treat Necrotizing Soft Tissue Infections
Necrotizing Soft Tissue Infections
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.
Damon Cooney, MD, PhD principal investigator
The Department of Plastic and Reconstructive Surgery, Johns Hopkins University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Acellular Adipose Tissue (AAT) in people with Soft Tissue Injuries and Trauma, 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 12 May 2026. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
AAT efficacy for soft-tissue reconstruction - Volume Retention (time frame: 6 months post-final injection). The study lists 3 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 NCT03544632, which also lists 8 linked publications.
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 12 May 2026.