Trauma Clinical Trial
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.
Status | Recruiting |
Enrollment | 15 |
Est. completion date | December 31, 2025 |
Est. primary completion date | February 28, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: 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). - 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). Exclusion Criteria: 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 >99ยบ F at time of screening) - Insulin dependent diabetes - Low vascularity of the tissue intended for elective excision - Local or Systemic Infection - 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 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 |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins University School of Medicine | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | Armed Forces Institute of Regenerative Medicine, U.S. Army Medical Research and Development Command |
United States,
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. — View Citation
Cheng 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. — View Citation
Cordeiro 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. — View Citation
Pulagam 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. — View Citation
Rosson 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. — View Citation
Uriel 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. — View Citation
Wan 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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | AAT efficacy for soft-tissue reconstruction - Volume Retention | Volume retention documented by pre-to-post injection volumetric changes as detected by 3-dimensional photography | 6 months post-final injection | |
Primary | 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 | 6 months post-final injection | |
Primary | AAT efficacy for soft-tissue reconstruction - patient-reported | Post-injection assessment to determine aesthetic outcome documented by patient-reported satisfaction with the repair | 6 months post-final injection | |
Secondary | 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 | up to 12 months post-injection | |
Secondary | Physician Ease of Use Assessments | Physician ease of use will be measured through the completion of self-administered surveys by the study surgeon. | up to 12 months post-injection | |
Secondary | Participant Comfort Surveys | Participant comfort will be measured through the completion of self-administered surveys by the participant. | up to 12 months post-injection |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04848376 -
Post-Market Clinical Follow-up Study of A-SPINE's Products
|
||
Terminated |
NCT03781817 -
Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children With Non-operative Fractures
|
Phase 4 | |
Completed |
NCT04342416 -
Using a Brief Visuospatial Interference Intervention to Reduce Intrusive Memories Among Trauma Exposed Women
|
N/A | |
Recruiting |
NCT04856449 -
DBT Skills Plus EMDR for BPD and Trauma
|
N/A | |
Completed |
NCT04356963 -
Adjunct VR Pain Management in Acute Brain Injury
|
N/A | |
Completed |
NCT05669313 -
The Effects of Hypothermia and Acidosis on Coagulation During Treatment With Rivaroxaban Measured With ROTEM
|
||
Active, not recruiting |
NCT03622632 -
Pilot Study to Measure Uric Acid in Traumatized Patients: Determinants and Prognostic Association
|
||
Recruiting |
NCT04725721 -
Testing FIRST in Youth Outpatient Psychotherapy
|
N/A | |
Active, not recruiting |
NCT05530642 -
An Augmented Training Program for Preventing Post-Traumatic Stress Injuries Among Diverse Public Safety Personnel
|
N/A | |
Not yet recruiting |
NCT05649891 -
Checklists Resuscitation Emergency Department
|
N/A | |
Not yet recruiting |
NCT03696563 -
FreeO2 PreHospital - Automated Oxygen Titration vs Manual Titration According to the BLS-PCS
|
N/A | |
Withdrawn |
NCT03249129 -
Identification of Autoantibodies and Autoantigens in the Cerebrospinal Fluid of Patients With Spinal Cord Trauma
|
||
Completed |
NCT02240732 -
Surgical Tourniquets and Cerebral Emboli
|
N/A | |
Completed |
NCT02227979 -
Effects of PURPLE Cry Intervention
|
N/A | |
Withdrawn |
NCT01169025 -
Fentanyl vs. Low-Dose Ketamine for the Relief of Moderate to Severe Pain in Aeromedical Patients
|
N/A | |
Recruiting |
NCT01812941 -
Evaluation of Mitochondrial Dysfunction in Severe Burn and Trauma Patients
|
N/A | |
Completed |
NCT01475344 -
Fibrinogen Concentrate (FGTW) in Trauma Patients, Presumed to Bleed (FI in TIC)
|
Phase 1/Phase 2 | |
Completed |
NCT03112304 -
Child STEPS for Youth Mental Health in Maine Sustainability
|
N/A | |
Completed |
NCT01210417 -
Trauma Heart to Arm Time
|
N/A | |
Completed |
NCT01201863 -
Neuroendocrine Dysfunction in Traumatic Brain Injury: Effects of Testosterone Therapy
|
Phase 4 |