AuriNovo for Auricular Reconstruction

Recruiting at 2 trial locations

Age: < 65

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: 3DBio Therapeutics

Must not be taking: Immunosuppressants, Aminoglycosides

Disqualifiers: Cochlear implant, Renal dysfunction, Keloids, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

2 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing AuriNovo, a custom-made biological ear implant, for people born with underdeveloped ears (microtia Grades II-IV). The study aims to ensure the safety of the implant and improve surgical techniques. The goal is to see how well the implant works and lasts. AuriNovo is developed using novel tissue engineering techniques, including a 3D-printed biodegradable auricle scaffold combined with patient-derived cells.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on immunosuppressants, you may not be eligible to participate.

How does the drug AuriNovo differ from other treatments for anorexia nervosa?

AuriNovo is unique because it targets specific neurons in the brain that are involved in feeding behavior, potentially increasing appetite and reducing anxiety, unlike traditional treatments that focus mainly on psychotherapy and nutritional support. ^{1 2 3 4 5}

Eligibility Criteria

Inclusion Criteria

Healthy subjects with no history of cancer, problematic wound healing, or immune disorders

Adhering to the follow-up schedule and post-surgery care instructions is able to be done.

The text is saying that the person needs to have an audiology assessment to make sure they are still eligible to be a part of the study and that the study will not prevent them from getting hearing correction surgery in the future.

Exclusion Criteria

You have had a surgery to implant a hearing device in the past.

Patients with prior surgery in the temporal, parietal, or mastoid regions of the affected side that resulted in scarring that may affect the outcome of microtia reconstruction surgery.

Sensitivity to materials of porcine origin including pork products. For subjects with no known exposure to porcine materials including pork products, sensitivity as confirmed at baseline through a positive porcine skin sensitivity test.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo surgical reconstruction of the external ear using the AuriNovo construct

3 months

Multiple visits for surgical procedure and post-surgical care

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of AEs and satisfaction scores

3 months

Regular follow-up visits

Treatment Details

Interventions

• AuriNovo

Participant Groups

Group I: AuriNovo Experimental Treatment 1 Intervention

AuriNovo is a patient-specific, biologically natural, supportive base for surgical reconstruction of the external ear (auricle) in people born with microtia Grades II-IV. The construct is a 3D-bioprinted collagen hydrogel scaffold encapsulating the patient's own auricular cartilage cells (chondrocytes). The construct is printed in a size and shape that matches the contralateral ear for implantation into the patient.

Who Is Running the Clinical Trial?

3DBio Therapeutics

Lead Sponsor

Trials

1

Recruited

2+

References

1. England pubmed.ncbi.nlm.nih.gov

Antimicrobial peptides in patients with anorexia nervosa: comparison with healthy controls and the impact of weight gain. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

N-terminal C-type natriuretic propeptide is associated with the endosteal apposition of bone in females with a persistent eating disorder. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

A small-molecule degrader of TET3 as treatment for anorexia nervosa in an animal model. [2023]

4. Japan pubmed.ncbi.nlm.nih.gov

Predictors of bone mineral density in adolescents with atypical anorexia nervosa. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Maintained malnutrition produces a progressive decrease in (OPG)/RANKL ratio and leptin levels in patients with anorexia nervosa. [2021]