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NCT03806361
Fat Grafts With Adipose-derived Regenerative Cells for Soft Tissue Reconstruction in Children
NA trial testing Fat grafts supplemented with ADRC in Craniofacial Microsomia in 30 participants. Completed in 10 January 2021.
10 January 2021
Quick facts
| Lead sponsor | Hospital Sirio-Libanes |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 10 January 2019 |
| Primary completion | 10 January 2021 |
| Estimated completion | 10 January 2021 |
| Sites | 1 location across Brazil |
Drugs / interventions tested
- Fat grafts supplemented with ADRC
- Structural fat grafting
Conditions studied
- Craniofacial Microsomia — all drugs for Craniofacial Microsomia →
Sponsor
Hospital Sirio-Libanes
Who can join
Adults 10 to 18, any sex, with Craniofacial Microsomia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Although first reports of the clinical use of adipose-derived regenerative cells (ADRC) suggest that this approach may be feasible and effective for soft tissue augmentation, there is a lack of randomized, controlled clinical trials in the literature. Hence, this study aimed to investigate whether a novel protocol for isolation of ADRC and their use in combination with fat tissue improve the long-term retention of the grafts in paediatric patients with craniofacial microsomia.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03806361
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03806361 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hospital Sirio-Libanes
- Last refreshed: 18 October 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03806361.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing