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New Fat-Based filler could permanently fix body defects

NCT ID NCT03544632

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

injury Soft Tissue Injuries

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.