NCT02494752

Brief Summary

Contour deformity of face causes both functional as well as aesthetic problems for the patient. Fat being an autologous tissue source is considered as an ideal soft-tissue filler because it is abundant, readily available, inexpensive, host compatible, and can be harvested easily and repeatedly. However absorption of grafted fat is a major problem resulting in lack of consistency of final clinical outcome. Adipose tissue derived mesenchymal stem cells have the potential to enhance the viability of the grafted fat and the reliability of the final outcome of surgery. In the current study potential of mesenchymal stem cells will be studied by comparing two groups of patients requiring fat grafting for contour deformities of face. Control group will have fat graft with out enrichment with stem cells whereas experimental group will have their fat graft enriched with mesenchymal stem cells. Comparison will be made regarding viability of grafted fat in two groups.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2015

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 4, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 10, 2015

Completed
22 days until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

July 10, 2015

Status Verified

July 1, 2015

Enrollment Period

6 months

First QC Date

July 4, 2015

Last Update Submit

July 9, 2015

Conditions

Romberg's DiseaseCraniofacial MicrosomiaLipodystrophyMixed Connective Tissue Disease

Keywords

Contour deformities of faceautologous fat graftingPost traumatic facial contour defects

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in thickness of subcutaneous tissue

    Objective assessment will be made by doing baseline B mode colour Doppler ultrasonography of the treated area.The operator blinded to the group allocation will measure the thickness of the subcutaneous tissue (in millimeters) in the treated area during the baseline examination with ultrasound B-mode. In order to have a reproducible measurement in subsequent examinations, the operator will look for and note down precise anatomical landmarks or, in case of large areas, will mark the points with an indelible marker, saving a digital image for future reference. Patients will again under go ultrasonography of the treated area at 24 weeks post treatment. During this repeat ultra sonography same operator will again measure the subcutaneous thickness of the treated in millimeters. The difference in two measurements will be noted down as residual volume. Means of residual volumes in two groups will be compared.

    24 weeks

Secondary Outcomes (1)

  • Change from base line in post operative appearance

    24 weeks

Study Arms (2)

Stem cell enriched

EXPERIMENTAL

Fat graft will be enriched with ex vivo expanded stem cells

Procedure: Fat graft enriched with ex vivo expanded stem cells

Non stem cell enriched

ACTIVE COMPARATOR

Fat graft will not be enriched with ex vivo expanded stem cells

Procedure: Fat graft not enriched with ex vivo expanded stem cells

Interventions

Fat graft enriched with ex vivo expanded stem cellsPROCEDURE

Fat graft will be enriched with ex vivo expanded stem cells

Stem cell enriched
Fat graft not enriched with ex vivo expanded stem cellsPROCEDURE

Fat graft will not be enriched with ex vivo expanded stem cells

Non stem cell enriched

Eligibility Criteria

Age16 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients with congenital and acquired contour deformities of face requiring soft tissue augmentation .
  • Must be 16-60 years of age
  • Must be American Society of Anesthesiology (ASA) class 1 and 2

You may not qualify if:

  • Patients with contour deformities in which skin is adherent to facial skeleton
  • Contour deformities underlying skin grafted areas of face
  • Abdominal skin pinch thickness less than 3 inch

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (14)

  • Cheong YW, Lo LJ. Facial asymmetry: etiology, evaluation, and management. Chang Gung Med J. 2011 Jul-Aug;34(4):341-51.

    PMID: 21880188BACKGROUND

  • Bucky LP, Kanchwala SK. The role of autologous fat and alternative fillers in the aging face. Plast Reconstr Surg. 2007 Nov;120(6 Suppl):89S-97S. doi: 10.1097/01.prs.0000248866.57638.40.

    PMID: 18090347BACKGROUND

  • Gir P, Brown SA, Oni G, Kashefi N, Mojallal A, Rohrich RJ. Fat grafting: evidence-based review on autologous fat harvesting, processing, reinjection, and storage. Plast Reconstr Surg. 2012 Jul;130(1):249-258. doi: 10.1097/PRS.0b013e318254b4d3.

    PMID: 22743888BACKGROUND

  • Brown SA, Levi B, Lequex C, Wong VW, Mojallal A, Longaker MT. Basic science review on adipose tissue for clinicians. Plast Reconstr Surg. 2010 Dec;126(6):1936-1946. doi: 10.1097/PRS.0b013e3181f44790.

    PMID: 21124133BACKGROUND

  • Baer PC, Geiger H. Adipose-derived mesenchymal stromal/stem cells: tissue localization, characterization, and heterogeneity. Stem Cells Int. 2012;2012:812693. doi: 10.1155/2012/812693. Epub 2012 Apr 12.

    PMID: 22577397BACKGROUND

  • Choudhery MS, Badowski M, Muise A, Pierce J, Harris DT. Donor age negatively impacts adipose tissue-derived mesenchymal stem cell expansion and differentiation. J Transl Med. 2014 Jan 7;12:8. doi: 10.1186/1479-5876-12-8.

    PMID: 24397850BACKGROUND

  • Choudhery MS, Badowski M, Muise A, Harris DT. Comparison of human mesenchymal stem cells derived from adipose and cord tissue. Cytotherapy. 2013 Mar;15(3):330-43. doi: 10.1016/j.jcyt.2012.11.010. Epub 2013 Jan 11.

    PMID: 23318344BACKGROUND

  • Choudhery MS, Badowski M, Muise A, Pierce J, Harris DT. Cryopreservation of whole adipose tissue for future use in regenerative medicine. J Surg Res. 2014 Mar;187(1):24-35. doi: 10.1016/j.jss.2013.09.027. Epub 2013 Oct 8.

    PMID: 24268882BACKGROUND

  • Tiryaki T, Findikli N, Tiryaki D. Staged stem cell-enriched tissue (SET) injections for soft tissue augmentation in hostile recipient areas: a preliminary report. Aesthetic Plast Surg. 2011 Dec;35(6):965-71. doi: 10.1007/s00266-011-9716-x. Epub 2011 Apr 13.

    PMID: 21487913BACKGROUND

  • Eto H, Kato H, Suga H, Aoi N, Doi K, Kuno S, Yoshimura K. The fate of adipocytes after nonvascularized fat grafting: evidence of early death and replacement of adipocytes. Plast Reconstr Surg. 2012 May;129(5):1081-1092. doi: 10.1097/PRS.0b013e31824a2b19.

    PMID: 22261562BACKGROUND

  • Gir P, Oni G, Brown SA, Mojallal A, Rohrich RJ. Human adipose stem cells: current clinical applications. Plast Reconstr Surg. 2012 Jun;129(6):1277-1290. doi: 10.1097/PRS.0b013e31824ecae6.

    PMID: 22634645BACKGROUND

  • Kolle SF, Fischer-Nielsen A, Mathiasen AB, Elberg JJ, Oliveri RS, Glovinski PV, Kastrup J, Kirchhoff M, Rasmussen BS, Talman ML, Thomsen C, Dickmeiss E, Drzewiecki KT. Enrichment of autologous fat grafts with ex-vivo expanded adipose tissue-derived stem cells for graft survival: a randomised placebo-controlled trial. Lancet. 2013 Sep 28;382(9898):1113-20. doi: 10.1016/S0140-6736(13)61410-5.

    PMID: 24075051BACKGROUND

  • Bollero D, Pozza S, Gangemi EN, De Marchi A, Ganem J, A M el K, Faletti C, Stella M. Contrast-enhanced ultrasonography evaluation after autologous fat grafting in scar revision. G Chir. 2014 Nov-Dec;35(11-12):266-73.

    PMID: 25644727BACKGROUND

  • Bashir MM, Sohail M, Ahmad FJ, Choudhery MS. Preenrichment with Adipose Tissue-Derived Stem Cells Improves Fat Graft Retention in Patients with Contour Deformities of the Face. Stem Cells Int. 2019 Nov 20;2019:5146594. doi: 10.1155/2019/5146594. eCollection 2019.

    PMID: 31827528DERIVED

MeSH Terms

Conditions

Facial HemiatrophyGoldenhar SyndromeLipodystrophyMixed Connective Tissue Disease

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesFacial Nerve DiseasesCranial Nerve DiseasesNervous System DiseasesMandibulofacial DysostosisCraniofacial DysostosisDysostosesBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesCraniofacial AbnormalitiesMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin Diseases, MetabolicSkin DiseasesSkin and Connective Tissue DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesConnective Tissue Diseases

Central Study Contacts

Muhammad M Bashir, F.C.P.S

CONTACT

923336517745mmbashir1@gmail.com

Mahmood S Chaudhry, PhD

CONTACT

923214110894ms20031@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor of Plastic Surgery

Study Record Dates

First Submitted

July 4, 2015

First Posted

July 10, 2015

Study Start

August 1, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

July 10, 2015

Record last verified: 2015-07