Allograft Adipose Matrix (AAM) in Subcutaneous Dorsal Wrist

MTF Biologics

Status: Completed

Conditions: Aesthetic Rejuvenation

Treatments: Other: Adipose Allograft Matrix (AAM) injection

Study type: Observational

Funder types: Other

Identifiers

NCT02445118

MTF 184N

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: Female

Ages: 35 to 75 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

15 participants in 1 patient group

Adipose Allograft Matrix Injection

Description:

AAM injected to create a 2 to 3mm raised wheal on the proximal dorsal wrist of the non-dominant hand

Treatment:

Other: Adipose Allograft Matrix (AAM) injection