Center for Innovation in Restorative Medicine (CIRM)

Center for Innovation in Restorative Medicine (CIRM)

Laboratory Director: J. Peter Rubin, MD

Director, Regulatory and Clinical Affairs: Patsy A. Simon, RN, BS, CCRC, CCRA

The UPMC Center for Innovation in Restorative Medicine (CIRM) is a nationally recognized center for excellence in regenerative medicine. As a comprehensive system of access, referral, evaluation, treatment, and long-term care, our center anables patients to explore and access the most promising potential treatments for severe, complex, or challenging injuries, especially where conventional options have been exhausted.

Research Description: 

Adipose Stromal Cell Enriched Autologous Fat Grafting for Treating Pain at Amputation Sites: A Single Center Site, Prospective, Randomized, Pilot Outcomes Trial (Amp 30)

PI: J. Peter Rubin, MD

Single center site, prospective, randomized, pilot outcomes study with treatment performed at the University of Pittsburgh.   Provide fat grafting to additional subcutaneous tissue padding over bony structures and nerve trunks. Limb anatomy and healing of the graft over time, along with stability/persistence of the new tissue, will be assessed by high resolution CT scanning with 3D reconstruction. Patients will be followed for 24 months after treatment to define long term outcomes. The primary outcome measures will be pain at the amputation site and improved ability to tolerate a prosthesis. Patients will be randomized to receive either standard fat grafting (15 patients) or cell enriched fat grafting (15 patients) utilizing the Tissue Genesis Cell Isolation System (CIS). Patients will be enrolled who have pain at an amputation site that limits function and/or interferes with the ability to use a prosthesis.

The Management of Closed Surgical Incisions Resulting From Incisional Hernia Repair and/or Functional Panniculectomy Using the Prevena™ Customizable™ Dressing (KCI)

PI: J. Peter Rubin, MD

The goal of this study is to evaluate the impact of Customizable in the management of extensive closed surgical incisions for Subjects undergoing abdominal surgery for incisional hernia repair and/or functional panniculectomy as compared to Standard of Care dressing, and to significantly reduce the Surgical Site Complications (SSC) rate experienced by Subjects receiving Customizable vs. SOC surgical incision dressing. Subjects will be followed for 30 days following surgical procedure.

In-Vivo Assessment of Adipose Allograft Extracellular Matrix in Abdominoplasty Patients (MTF)

PI: J. Peter Rubin, MD

This is a prospective, randomized, two arm, single center study to assess adipose tissue development and retention when an implantable allograft adipose matrix (‘AAM’) is injected in the abdominal subcutaneous tissue of healthy volunteers undergoing elective standard-of-care panniculectomy. This study will enroll ten (10) subjects. These subjects will be randomized to one of two study arms. Arm 1 will consist of five (5) subjects who will receive injections of AAM to be followed clinically for three (3) months duration, and arm 2 will consist of five (5) subjects who will receive injections of AAM to be followed clinically for six (6) months duration. At the point of completion of each arm, 3 or 6 months, the injected tissue will be surgically removed as part of the panniculectomy procedure. Samples of the AAM injected tissue areas and surrounding tissue will be obtained and processed for histologic evaluation.

Pressure Ulcer Monitoring Platform (PUMP)

PI: J. Peter Rubin, MD

This study will employ two monitoring device prototypes. The devices are sensors containing accelerometers and gyroscope. The raw output data will be analyzed to determine when patients are moved or are repositioned in their beds. The data is captured within a modem which will correlate these movements with video recordings for interpretation by the research team. One sensor is wearable on the patient gown or sleepwear, and the other is placed underneath the frame of the hospital bed. The investigators propose a non-blinded trial with n=10 where all subjects will undergo the two devices. A video camera will be placed in each subject room for recording the repositioning events to correlate the monitor signals with the actual subject repositioning captured by the video. The goal of the trial is to validate the ability of each of the sensor prototypes to accurately detect when subjects are turned, in order to reduce stationary positioning which contributes to the incidence of pressure ulcers and to improve compliance with patient repositioning trials.

A Multicenter, Prospective, Randomized, Subject and Evaluator Blinded Comparative Study of Nerve Cuffs and Avance® Nerve Graft Evaluating Recovery Outcomes for the Repair of Nerve Discontinuities (AXOGEN)

PI:   Alexander Spiess, MD

Processed Nerve Allograft and Collagen Nerve Cuffs will be compared to assess safety and functional outcomes for the repair of nerve injuries in the hand. Subjects followed for 1 year following surgical procedure.

Fat Grafting and Retention for Heel Fat Pad Atrophy

PI:   Jeffrey Gusenoff, MD

The specific aim of this study is to assess the adipose stem cell characteristics in patients undergoing autologous fat grafting for heel fat pad atrophy and correlate these characteristics with fat retention.

Perforating Fat Injections for Plantar Fasciosis (PRF)

PI: Jeffrey Gusenoff, MD

The specific aim of this study is to determine whether perforating fat injections to the plantar fascia is a safe method to improve pain, quality of life, and reduce plantar fascia thickness for patients with chronic plantar fasciitis. We will also correlate the intrinsic fat properties of adipose stem cells (ie. growth factors) to the improvement in pain, quality of life, and plantar fascia thickness over time.