Facial InjuriesAFIRM-TGINCT01924364
Effect of Concentrating Endogenous Stromal Cells in the Fat Graft Using TGI Device
A study testing Tissue Genesis Cell Isolation System™ (TGI CIS) in people with Facial Injuries and Tissue Injury, run by J. Peter Rubin, MD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Facial Injuries, Tissue Injury
- What is being tested?
- Tissue Genesis Cell Isolation System™ (TGI CIS)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2012to 28 Sep 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Subjects who are male or female, military or civilian, 18 years of age or older and able to provide informed consent
- 2. Have suffered injury resulting in craniofacial volume defects which could be treated with a graft volume of between 3 and 100 cc of lipoaspirate
- 3. Be at least 3 months post-injury or post-surgery (from trauma procedures) so that acute edema is resolved
- 4. Volume defects are covered by intact skin and do not communicate with oral cavity or sinuses
- 5. 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.
- 6. 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
Who cannot join
- 1. 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).
- 2. Active infection anywhere in the body
- 3. Diagnosis of cancer within last 12 months and /or actively receiving chemotherapy or radiation treatment
- 4. Subjects with known idiopathic or drug-associated coagulopathy assessed by screening history and physical examination.
- 5. 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.
- 6. 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
Show all 11Show fewer
- 7. Subjects with known alcohol or narcotic drug dependency
- 8. 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)
- 9. Subjects with a life expectancy of <9 months, terminal conditions or factors making follow-up difficult (e.g. no fixed address, telephone etc)
- 10. Subjects with a known allergy to collagenase, an ingredient used by the TGI CIS to process the SVF product.
- 11. 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Structural Fat Grafting for Craniofacial Trauma: Effect of Concentrating Endogenous Stromal Cells in the Fat Graft Using the Tissue Genesis Cell Isolation System™ (CIS) Device
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.
Read the detailed description
The primary objective of the proposed clinical investigation of the Tissue Genesis Cell Isolation System™ (TGI CIS) device constitutes a feasibility study directed at an initial evaluation of the device in a certain clinical population, namely subjects undergoing craniofacial fat grafting.
- Treat disfiguring craniofacial injuries in 5 subjects with fat grafting enhanced with adipose stromal vascular fraction (SVF) via TGI 1000 isolation methods to improve form with a high level of precision. Facial appearance and persistence of treatment effect will be assessed using aesthetic grading scales, state of the art 3-dimensional (3D) photography, and high resolution computed tomography (CT) scanning with 3D reconstruction. Patients will be followed for 24 months after treatment to define long term outcomes.
- Assess biologic properties of the cells within the fat graft and correlate with clinical outcomes. This will include adipose stem cell yield per volume of fat tissue, cell proliferation, capacity for adipogenic differentiation, lipolysis, and cell sub-population analysis by multiparameter flow cytometry. Results of these assays will be correlated with graft volume retention to search for predictors of good clinical outcome that are related to variation on adipose biology between subjects.
- Measure quality of life in patients before and after autologous fat grafting using validated psychosocial measures.
- Conditions
- Facial Injuries, Tissue Injury
- Being tested
- Tissue Genesis Cell Isolation System™ (TGI CIS), Standard of care fat grafting
- Keywords
- Craniomaxillofacial (CMF) Battle-injured (BI), Facial Trauma, Fat Grafts, Autogenous Fat Transfers (AFT), Wounded warriors
- Medical subject headings
- Facial Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Standard of care fat graftingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Standard of care fat grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
this describes the biologic properties of the cells within the fat graft
Measured: Surgical visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2013 (estimated)
- Study start30 Jun 2012
- Primary completion28 Sep 2016
- Study completion28 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Facial InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- J. Peter Rubin, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, J. Peter Rubin, MD, University of Pittsburgh
- Investigators
- J. Peter Rubin, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01924364
- Sponsor's protocol ID
- PRO12030255
- Acronym
- AFIRM-TGI
- Status last verified
- Apr 2018
- First submitted
- 21 Dec 2012
- Last updated
- 11 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: It is the Principal Investigator's intention to make stored samples and subject de-identified information available to secondary investigators after all research study testing has been completed. These stored samples and associated subject information will not include subject identifiers.
Publications
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.
PubMed 17763894Zhu 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.
PubMed 20098110
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structural Fat Grafting for Craniofacial Trauma: Effect of Concentrating Endogenous Stromal Cells in the Fat Graft Using the Tissue Genesis Cell Isolation System™ (CIS) Device
- ClinicalTrials.gov ID
- NCT01924364
- Acronym / sponsor ID
- AFIRM-TGI / PRO12030255
- Conditions
- Facial Injuries, Tissue Injury
- Keywords
- Craniomaxillofacial (CMF) Battle-injured (BI), Facial Trauma, Fat Grafts, Autogenous Fat Transfers (AFT), Wounded warriors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- J. Peter Rubin, MDUniversity, hospital or other
- Study start
- 30 Jun 2012 (actual)
- Primary completion
- 28 Sep 2016 (actual)
- Study completion
- 28 Sep 2016 (actual)
- First posted
- 16 Aug 2013 (estimated)
- Results
- Posted 11 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary objective of the proposed clinical investigation of the Tissue Genesis Cell Isolation System™ (TGI CIS) device constitutes a feasibility study directed at an initial evaluation of the device in a certain clinical population, namely subjects undergoing craniofacial fat grafting.
- Treat disfiguring craniofacial injuries in 5 subjects with fat grafting enhanced with adipose stromal vascular fraction (SVF) via TGI 1000 isolation methods to improve form with a high level of precision. Facial appearance and persistence of treatment effect will be assessed using aesthetic grading scales, state of the art 3-dimensional (3D) photography, and high resolution computed tomography (CT) scanning with 3D reconstruction. Patients will be followed for 24 months after treatment to define long term outcomes.
- Assess biologic properties of the cells within the fat graft and correlate with clinical outcomes. This will include adipose stem cell yield per volume of fat tissue, cell proliferation, capacity for adipogenic differentiation, lipolysis, and cell sub-population analysis by multiparameter flow cytometry. Results of these assays will be correlated with graft volume retention to search for predictors of good clinical outcome that are related to variation on adipose biology between subjects.
- Measure quality of life in patients before and after autologous fat grafting using validated psychosocial measures.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Fat grafting with TGI | Experimental | Device: Tissue Genesis Cell Isolation System™ (TGI CIS)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. |
| Fat grafting without TGI - Standard of care | Sham comparator | Procedure: Standard of care fat graftingIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1. Subjects who are male or female, military or civilian, 18 years of age or older and able to provide informed consent
- 2. Have suffered injury resulting in craniofacial volume defects which could be treated with a graft volume of between 3 and 100 cc of lipoaspirate
- 3. Be at least 3 months post-injury or post-surgery (from trauma procedures) so that acute edema is resolved
- 4. Volume defects are covered by intact skin and do not communicate with oral cavity or sinuses
- 5. 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.
Key exclusion criteria (11 listed)
- 1. 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).
- 2. Active infection anywhere in the body
- 3. Diagnosis of cancer within last 12 months and /or actively receiving chemotherapy or radiation treatment
- 4. Subjects with known idiopathic or drug-associated coagulopathy assessed by screening history and physical examination.
- 5. 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tissue Genesis Cell Isolation System™ (TGI CIS)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. | Device | Fat grafting with TGI |
| Standard of care fat graftingIn 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. | Procedure or surgery | Fat grafting without TGI - Standard of care |
Primary outcome
Total Fat Volume Injected and Facial Volume Postop
Time frame: Surgical visit, PO Study visits month 3, month 9, month 12, and month 24
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.
1 secondary outcome
Adipose Stem Cell Yield Per Volume of Fat Tissue
Time frame: Surgical visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17763894Yoshimura 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.
- Background: PubMed 20098110Zhu 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.
- Individual participant dataSharing planned: Yes. It is the Principal Investigator's intention to make stored samples and subject de-identified information available to secondary investigators after all research study testing has been completed. These stored samples and associated subject information will not include subject identifiers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J. Peter Rubin, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tissue Genesis Cell Isolation System™ (TGI CIS) in people with Facial Injuries and Tissue Injury, run by J. Peter Rubin, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Fat Volume Injected and Facial Volume Postop (time frame: Surgical visit, PO Study visits month 3, month 9, month 12, and month 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01924364, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2018.