Effect of Concentrating Endogenous Stromal Cells in the Fat Graft Using TGI Device

NCT01924364 | Completed Results DMC

• 1 other identifier: PRO12030255
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

The overall purpose of this research is to evaluate the physical changes that occur over time after fat grafting for craniofacial trauma. This protocol is similar to an existing study (IRB# PRO0906101) presently conducted at the University of Pittsburgh by the same research team which utilizes fat grafts. The preparation of the fat graft material in each clinical trial is processed differently evaluating the effects of graft resorption after treatment.

Conditions

Facial Injuries; Tissue Injury

Keywords

Craniomaxillofacial (CMF) Battle-injured (BI); Facial Trauma; Fat Grafts; Autogenous Fat Transfers (AFT); Wounded warriors

Outcome Measures

Primary Outcomes (1)

• Total Fat Volume Injected and Facial Volume Postop

  Facial appearance and persistence of treatment effect will be assessed using high resolution CT scanning with 3D reconstruction. Patients will be followed for 24 months after treatment to define long term outcomes.

  Surgical visit, PO Study visits month 3, month 9, month 12, and month 24

Secondary Outcomes (1)

• Adipose Stem Cell Yield Per Volume of Fat Tissue

  Surgical visit

Study Arms (2)

Fat grafting with TGI

EXPERIMENTAL

In this study, we will concentrate the adipose stromal cells (ASCs) in the fat graft material to assess whether this modification will increase fat graft retention over time. The concentrated fat to be injected into the subject from the fat grafting procedure will be processed by the Tissue Genesis Cell Isolation System™ (TGI-CIS) device. The volume retention in areas treated with ASC concentrated fat grafts will be compared with regions treated with standard fat grafts in the same patient.

Device: Tissue Genesis Cell Isolation System™ (TGI CIS)

Fat grafting without TGI - Standard of care

SHAM COMPARATOR

In this study, we will concentrate the adipose stromal cells (ASCs) in the fat graft material to assess whether this modification will increase fat graft retention over time. The concentrated fat to be injected into the subject from the fat grafting procedure will be NOT processed by the Tissue Genesis Cell Isolation System™ (TGI-CIS) device. The volume retention in areas treated with ASC concentrated fat grafts will be compared with regions treated with standard fat grafts in the same patient.

Procedure: Standard of care fat grafting

Interventions

Tissue Genesis Cell Isolation System™ (TGI CIS) DEVICE

In this study, we will concentrate the adipose stromal cells (ASCs) in the fat graft material to assess whether this modification will increase fat graft retention over time. The concentrated fat to be injected into the subject from the fat grafting procedure will be processed by the Tissue Genesis Cell Isolation System™ (CIS) device. The volume retention in areas treated with ASC concentrated fat grafts will be compared with regions treated with standard fat grafts in the same patient. Additionally, data from our current study assessing volume retention after fat grafting for facial deformities (IRB # PRO09060101, NCT01345591) will be used for comparison.

Fat grafting with TGI

Standard of care fat grafting PROCEDURE

In this study, we will concentrate the adipose stromal cells (ASCs) in the fat graft material to assess whether this modification will increase fat graft retention over time.

Fat grafting without TGI - Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Subjects who are male or female, military or civilian, 18 years of age or older and able to provide informed consent
• \. Have suffered injury resulting in craniofacial volume defects which could be treated with a graft volume of between 3 and 100 cc of lipoaspirate
• \. Be at least 3 months post-injury or post-surgery (from trauma procedures) so that acute edema is resolved
• \. Volume defects are covered by intact skin and do not communicate with oral cavity or sinuses
• \. The three dimensional geometry of the volume defects would allow for treatment with lipoaspirate injection so that at least two distinct treated areas could be discerned on gross examination and radiographically (e.g. treated regions are on opposite sides of the face, on lower face versus upper face, or separated by a bony landmark such as zygoma. This would include the ability to treat uninjured regions with fat grafts in order to obtain symmetry or balance.
• \. Subjects who are, in the opinion of the Investigator, able to understand the study, comply with the study design and are willing to return to the clinic for all the research required follow-up visits

You may not qualify if:

• \. Craniofacial defects intended for treatment have open wounds or communicate with oral cavity or sinus (note: presence of such a defect in the setting of another defect(s) that meets treatment criteria will not exclude the patient from participating).
• \. Active infection anywhere in the body
• \. Diagnosis of cancer within last 12 months and /or actively receiving chemotherapy or radiation treatment
• \. Subjects with known idiopathic or drug-associated coagulopathy assessed by screening history and physical examination.
• \. Subjects who have, as determined by the investigator a history or clinical manifestations of significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, or other condition that would preclude participation in the study (i.e. Type 1 and Type 2 diabetic patients) or any condition within the last 14 days requiring hospitalization or surgical intervention.
• \. Subjects who are pregnant, lactating, and women of child-bearing potential who are not abstinent or practicing an acceptable means of contraception, as determined by the Investigator, for the duration of the treatment phase
• \. Subjects with known alcohol or narcotic drug dependency
• \. Subjects with a history of abnormal blood biochemistry or any other abnormal laboratory findings, as defined by the normal value range within the UPMC Laboratory's value references and whose values are considered as determined by the investigator to be clinically significant, would render the subject inappropriate for the surgical procedures (i.e. CBC with Differential, platelets, comprehensive metabolic panel to include electrolytes, bun/creatinine, liver function test and coagulation tests). Reference to UPMC Laboratory normal value document (Attachment # 18)
• \. Subjects with a life expectancy of \<9 months, terminal conditions or factors making follow-up difficult (e.g. no fixed address, telephone etc)
• \. Subjects with a known allergy to collagenase, an ingredient used by the TGI CIS to process the SVF product.
• \. Subjects with an Axis II to diagnosis DSM-IV (e.g., Schizophrenia, Bipolar Disorder). Subjects who are found to be stable on medication and receive psychiatric clearance could be eligible for study participation per the Physician's discretion.

Sponsors & Collaborators

• J. Peter Rubin, MD: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (2)

• Yoshimura K, Sato K, Aoi N, Kurita M, Hirohi T, Harii K. Cell-assisted lipotransfer for cosmetic breast augmentation: supportive use of adipose-derived stem/stromal cells. Aesthetic Plast Surg. 2008 Jan;32(1):48-55; discussion 56-7. doi: 10.1007/s00266-007-9019-4. Epub 2007 Sep 1.

  PMID: 17763894 BACKGROUND

• Zhu M, Zhou Z, Chen Y, Schreiber R, Ransom JT, Fraser JK, Hedrick MH, Pinkernell K, Kuo HC. Supplementation of fat grafts with adipose-derived regenerative cells improves long-term graft retention. Ann Plast Surg. 2010 Feb;64(2):222-8. doi: 10.1097/SAP.0b013e31819ae05c.

  PMID: 20098110 BACKGROUND

MeSH Terms

Conditions

Facial Injuries

Condition Hierarchy (Ancestors)

Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries

Results Point of Contact

• Title: Danielle Minteer
• Organization: University of Pittsburgh Plastic Surgery

minteerdm@upmc.edu

412-383-4804

Study Officials

• J. Peter Rubin, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: split-person study in which different parts of the same person may be assigned to receive different interventions, randomization occurs in regards to which site receives TGI or no TGI per site.

Study Record Dates

• First Submitted: December 21, 2012
• First Posted: August 16, 2013
• Study Start: June 30, 2012
• Primary Completion: September 28, 2016
• Study Completion: September 28, 2016
• Last Updated: May 11, 2018
• Results First Posted: May 11, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)