New Fat-Based filler could permanently fix body defects
NCT ID NCT03544632
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a new injectable material called acellular adipose tissue (AAT) to repair modest soft tissue defects on the trunk, such as those from injury or surgery. Fifteen adults received one or more injections of AAT, which is made from donated fat cells stripped of their living components. The goal was to see if the filler is safe and stays in place to improve appearance over 12 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- acellular adipose tissue (AAT)
- What this could lead to
- If it works, this could offer a permanent, natural-looking option for repairing soft tissue defects without needing the patient's own fat or repeated injections.
- What could go wrong
- This is a small, early-phase study with only 15 people, so results may not apply to everyone. The injection is permanent, so any complications like infection or poor cosmetic outcome would be difficult to reverse.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
15 people
The number who actually took part.
- Started
-
Jun 2018
- Finished
-
Feb 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 \>99º 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287, United States
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