Clinical trial NCT02445118: Allograft Adipose Matrix (AAM) in Subcutaneous Dorsal Wrist
Official title: Local Skin and Volume Changes With the Use of Allograft Adipose Matrix (AAM) in the Subcutaneous Human Dorsal Wrist, a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aesthetic Rejuvenation
Keywords: adipose, allograft
Lead sponsor: Musculoskeletal Transplant Foundation
Sponsor class: OTHER
First posted: 2015-05-15
Enrollment: 15
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Female,
* Between 35 and 75 years of age,
* Well controlled blood pressure,
* Able to sign an informed consent

Exclusion Criteria:

* 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)

Primary outcomes:
measure: 2-3mm raised wheal volume retention in dorsal wrist injected with AAM at 16 weeks
timeFrame: 16 weeks
Secondary outcomes:
measure: Sub-Dermal Tissue Analysis
timeFrame: 16 weeks
measure: Local skin changes
timeFrame: 16 weeks
measure: Volume retention during the study interim period, documented at weeks 2 and 10
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Key Biscayne
country: United States
facility: Miami Hand Center
state: Florida
city: New York
country: United States
facility: Tribeca Plastic Surgery
state: New York
Study officials:
affiliation: Study Principal Investigator
name: Sydney R. Coleman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Study Principal Investigator
name: Roger K Khouri, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.