Aesthetic RejuvenationNCT02445118
Allograft Adipose Matrix (AAM) in Subcutaneous Dorsal Wrist
An observational study of Aesthetic Rejuvenation, run by Musculoskeletal Transplant Foundation at 2 sites in United States.
Trial summary
This is a 16 week pilot study to assess short term outcomes of an injectable allograft adipose matrix (AAM) in the subcutaneous space in the dorsum of the wrist. A total of 30 patients will be enrolled at 2 sites and will be followed for sixteen weeks. Read more about this study
- Who is it for?
- Ages 35 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Aesthetic Rejuvenation
- What is being tested?
- Adipose Allograft Matrix (AAM) injection
- Type of treatment
- Injection or infusion
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2015to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 35 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Non-smoking females between 45 and 65 years of age with a BMI <30, with well controlled blood pressure, no active infections, collagen disorders,vascular diseases, history of lymphedema, mastectomy, lymph node dissection, end stage organ failure such as COPD, CRF, or CHF, and who have not undergone deep chemical peels, laser, Ultherapy, Thermage or other light or energy based procedures to the dorsum of the hands within the past year.
Who may be able to join
- Female,
- Between 35 and 75 years of age,
- Well controlled blood pressure,
- Able to sign an informed consent
Who cannot join
- Patients with active infection,
- Patients with a body weight change of greater than 5% throughout the 16 weeks of their participation,
- Patients with a BMI of greater than 30,
- Patients with a collagen vascular disease,
- Patients with end-stage organ failure (advanced COPD, CRF, CHF),
- Patients with lymphedema or mastectomy or axillary lymph node dissection, Patients who smoke,
- Patients that have undergone deep chemical peels, lasers, Ultherapy, Thermage, other light or energy based procedures to the dorsum of the hands one year prior,
- Patients who have taken any medication or oral supplements for the previous 4 weeks that could prolong bleeding time (e.g; Aspirin, Plavix, nutritional supplements starting with G, omega-3 , fish oil, etc)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Miami Hand Center
Key Biscayne, Florida, 33149
Tribeca Plastic Surgery
New York, New York, 10013
About this study
Official title: Local Skin and Volume Changes With the Use of Allograft Adipose Matrix (AAM) in the Subcutaneous Human Dorsal Wrist, a Pilot Study
This is a 16 week pilot study to assess short term outcomes of an injectable allograft adipose matrix (AAM) in the subcutaneous space in the dorsum of the wrist. A total of 30 patients will be enrolled at 2 sites and will be followed for sixteen weeks. Volume retention and local skin changes will be observed and documented prior to and following injection at week 0 and at follow up visits at 2, 10 and 16 weeks. Evaluations will be done via photographic analysis at week 0,2,10 and 16 weeks and half of the patients will undergo magnetic resonance imaging at week zero and at week 16. The dominant wrist will serve as a control and will receive no injection. Analysis includes volume retention, tissue analysis, local skin changes and adverse events, if any.
Read the detailed description
This pilot study focuses on three primary objectives: to evaluate volume retention at the site of injected allograft adipose matrix (AAM), to obtain tissue analysis via magnetic resonance imaging at the site of injection and to evaluate local skin changes as a result of the injection of AAM with follow up over a 16 week period. The AAM is derived from cadaveric human adipose recovered, processed, dehydrated and distributed by the study sponsor from thoroughly screened donors. It is distributed with instructions for rehydration prior to single use. The injection site (non-dominant wrist) will be infiltrated with Lidocaine 0.5%, Epinepherine 1:200,000 prior to AAM injection. Volume of AAM necessary to create a centered 2-3mm raised wheal at the first proximal dorsal wrist crease will be administered. Photographs taken prior and following the injection and at each of the subsequent visits are taken with a color standard within the frame for later color change analysis of the injection surrounding area. Both the control and treated hand/wrist will be photographed separately in numerous positions (extension, flexion and several degrees of either) at heart level, at week 0,2,10 and 16 weeks. A clinical assessment scale for evaluation of skin changes in appearance will also be done at these same times. Patients will be advised to avoid prolonged pressure to the dorsal wrists, wear no jewelry or wrist bands, etc., for the duration of their participation in the study. Those patients designated for MR imaging shall have their MRIs done within 3 to 5 days of their week zero and week16 visits. The images shall be read and documented by a single independent radiologist.
- Conditions
- Aesthetic Rejuvenation
- Being tested
- Adipose Allograft Matrix (AAM) injection
- Keywords
- adipose, allograft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adipose Allograft Matrix (AAM) injectionOther
Adipose Allograft Matrix (AAM) injection, Non-dominant wrist
| Study group | Role | What they receive |
|---|---|---|
| Adipose Allograft Matrix Injection | AAM injected to create a 2 to 3mm raised wheal on the proximal dorsal wrist of the non-dominant hand Receives: Other: Adipose Allograft Matrix (AAM) injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-3mm raised wheal volume retention in dorsal wrist injected with AAM at 16 weeks
Using a volume assessment scale photographs of treated vs. non-treated dorsal wrist will be evaluated by three plastic surgeons, with mean outcomes for each patient documented as final evidence
Measured: 16 weeks
Secondary outcomes (3)
Sub-Dermal Tissue Analysis
Magnetic resonance imaging taken at pre-injection (Week 0) and at 16 weeks of treated and non treated dorsal wrists will be evaluated by an independent radiologist for sub dermal adipose persistence
Measured: 16 weeks
Local skin changes
via clinical observation and photographic evidence taken at pre-injection and at pre and post week 0, 2,10 and 16 weeks of treated and non treated dorsal wrists. local skin changes such as pore size, redness, swelling will be documented by study surgeon
Measured: 16 weeks
Volume retention during the study interim period, documented at weeks 2 and 10
Using a volume assessment scale, photographs of treated vs. non-treated dorsal wrist will be evaluated by three plastic surgeons, using data collected at interim time points during the study; specifically, week 2 and week 10
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2015 (estimated)
- Study startMay 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aesthetic RejuvenationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Musculoskeletal Transplant Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sydney R. Coleman, MD, Principal investigator, Study Principal InvestigatorRoger K Khouri, MD, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02445118
- Sponsor's protocol ID
- MTF 184N
- Status last verified
- May 2015
- First submitted
- 25 Mar 2015
- Last updated
- 10 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kokai LE, Schilling BK, Chnari E, Huang YC, Imming EA, Karunamurthy A, Khouri RK, D'Amico RA, Coleman SR, Marra KG, Rubin JP. Injectable Allograft Adipose Matrix Supports Adipogenic Tissue Remodeling in the Nude Mouse and Human. Plast Reconstr Surg. 2019 Feb;143(2):299e-309e. doi: 10.1097/PRS.0000000000005269.
PubMed 30688888
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Skin and Volume Changes With the Use of Allograft Adipose Matrix (AAM) in the Subcutaneous Human Dorsal Wrist, a Pilot Study
- ClinicalTrials.gov ID
- NCT02445118
- Acronym / sponsor ID
- MTF 184N
- Conditions
- Aesthetic Rejuvenation
- Keywords
- adipose, allograft
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Musculoskeletal Transplant FoundationUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 15 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 16 week pilot study to assess short term outcomes of an injectable allograft adipose matrix (AAM) in the subcutaneous space in the dorsum of the wrist. A total of 30 patients will be enrolled at 2 sites and will be followed for sixteen weeks. Volume retention and local skin changes will be observed and documented prior to and following injection at week 0 and at follow up visits at 2, 10 and 16 weeks. Evaluations will be done via photographic analysis at week 0,2,10 and 16 weeks and half of the patients will undergo magnetic resonance imaging at week zero and at week 16. The dominant wrist will serve as a control and will receive no injection. Analysis includes volume retention, tissue analysis, local skin changes and adverse events, if any.
Detailed description
This pilot study focuses on three primary objectives: to evaluate volume retention at the site of injected allograft adipose matrix (AAM), to obtain tissue analysis via magnetic resonance imaging at the site of injection and to evaluate local skin changes as a result of the injection of AAM with follow up over a 16 week period. The AAM is derived from cadaveric human adipose recovered, processed, dehydrated and distributed by the study sponsor from thoroughly screened donors. It is distributed with instructions for rehydration prior to single use. The injection site (non-dominant wrist) will be infiltrated with Lidocaine 0.5%, Epinepherine 1:200,000 prior to AAM injection. Volume of AAM necessary to create a centered 2-3mm raised wheal at the first proximal dorsal wrist crease will be administered. Photographs taken prior and following the injection and at each of the subsequent visits are taken with a color standard within the frame for later color change analysis of the injection surrounding area. Both the control and treated hand/wrist will be photographed separately in numerous positions (extension, flexion and several degrees of either) at heart level, at week 0,2,10 and 16 weeks. A clinical assessment scale for evaluation of skin changes in appearance will also be done at these same times. Patients will be advised to avoid prolonged pressure to the dorsal wrists, wear no jewelry or wrist bands, etc., for the duration of their participation in the study. Those patients designated for MR imaging shall have their MRIs done within 3 to 5 days of their week zero and week16 visits. The images shall be read and documented by a single independent radiologist.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adipose Allograft Matrix Injection | – | Other: Adipose Allograft Matrix (AAM) injectionAAM injected to create a 2 to 3mm raised wheal on the proximal dorsal wrist of the non-dominant hand |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Non-smoking females between 45 and 65 years of age with a BMI <30, with well controlled blood pressure, no active infections, collagen disorders,vascular diseases, history of lymphedema, mastectomy, lymph node dissection, end stage organ failure such as COPD, CRF, or CHF, and who have not undergone deep chemical peels, laser, Ultherapy, Thermage or other light or energy based procedures to the dorsum of the hands within the past year.
Key inclusion criteria (4 listed)
- Female,
- Between 35 and 75 years of age,
- Well controlled blood pressure,
- Able to sign an informed consent
Key exclusion criteria (8 listed)
- Patients with active infection,
- Patients with a body weight change of greater than 5% throughout the 16 weeks of their participation,
- Patients with a BMI of greater than 30,
- Patients with a collagen vascular disease,
- Patients with end-stage organ failure (advanced COPD, CRF, CHF),
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 |
|---|---|---|
| Adipose Allograft Matrix (AAM) injectionAdipose Allograft Matrix (AAM) injection, Non-dominant wrist | Other | Adipose Allograft Matrix Injection |
Primary outcome
2-3mm raised wheal volume retention in dorsal wrist injected with AAM at 16 weeks
Time frame: 16 weeks
Using a volume assessment scale photographs of treated vs. non-treated dorsal wrist will be evaluated by three plastic surgeons, with mean outcomes for each patient documented as final evidence
3 secondary outcomes
Sub-Dermal Tissue Analysis
Time frame: 16 weeks
Local skin changes
Time frame: 16 weeks
Volume retention during the study interim period, documented at weeks 2 and 10
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2016.
- Derived from this study: PubMed 30688888Kokai LE, Schilling BK, Chnari E, Huang YC, Imming EA, Karunamurthy A, Khouri RK, D'Amico RA, Coleman SR, Marra KG, Rubin JP. Injectable Allograft Adipose Matrix Supports Adipogenic Tissue Remodeling in the Nude Mouse and Human. Plast Reconstr Surg. 2019 Feb;143(2):299e-309e. doi: 10.1097/PRS.0000000000005269.
- Individual participant dataSharing planned: No
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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.
Sydney R. Coleman, MD principal investigator
Study Principal Investigator
Roger K Khouri, MD principal investigator
Study Principal Investigator
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aesthetic Rejuvenation, run by Musculoskeletal Transplant Foundation at 2 sites 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 4 inclusion and 8 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 10 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
2-3mm raised wheal volume retention in dorsal wrist injected with AAM at 16 weeks (time frame: 16 weeks). 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 NCT02445118, which also lists 1 linked publication.
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 10 Aug 2016.