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.
Title: XENMATRIX™ AB Surgical Graft for the repair of severe musculotendinous tissue damaged by soft tissue trauma
PI: J. Peter Rubin, MD
Description: We propose in this project to use XENMATRIX™ AB Surgical Graft which has 510(k) approval [#K162193] intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue, including abdominal plastic and reconstructive surgery; muscle flap reinforcement; hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias. The graft has an antibiotic coating, specifically, Rifampin and Minocycline. This coating has been shown in preclinical in vitro and in vivo testing to reduce or inhibit microbial colonization on the device. The claim of reduction of bacterial colonization of the device has not yet been established with human clinical data, nor has a clinical impact associated with this claim been demonstrated and will need further investigation. This trial proposes to test the applicability and utility of XENMATRIX™ AB Surgical Graft in the restoration of function in the setting of volumetric muscle loss after trauma. Prior to Graft implantation, subjects will receive a pre-operative course of physical therapy for a maximum time period of 16 weeks. A physical therapist will confirm that functional plateau is reached prior to implantation of the Graft. Following Graft implantation, radiographic, functional, and electro physiotherapy outcomes will be measured at various time points up to 22-30 weeks post-operatively. A CT scan or MRI will be collected at the screening visit to evaluate tissue volume, then again at post-operative Visit 5. Physical therapy training will be performed as a research procedure following graft implantation for a maximum of 30 weeks. Additionally, physical therapy evaluations will be conducted at screening, pre-op visit 1, post-op visits 1, 2, 3, 4 and 5. A small core needle biopsy 1-5 grams will be collected at three time points to conduct histomorphological assessment of the tissue prior to graft implantation (Operative visit, Visit 3 and at Visit 5).
Primary & Secondary Objectives: The primary objective of the study is to assess the ability of XENMATRIX AB™ Surgical Graft to restore both function and mechanical strength.
The secondary objectives are 1) to assess the rate of infection in the use of the XENMATRIX AB™ Surgical Graft and 2) to examine the histologic properties of the biopsy tissue material in each subject for future correlation with clinical outcomes.
1.) Assessment of patient extremity function and mechanical strength post implantation of XENMATRIX AB™ Surgical Graft; after skeletal muscle injury.
- Patient rate of infection with the use of XENMATRIX AB™ Surgical Graft;
- Examination of histological properties of the biopsy tissue material in each subject for future correlation with clinical outcomes.
Numbers of subjects to undergo intervention: 10
Title: Randomized controlled trial assessing a novel glycopolymer compound in the treatment of superficial, partial-thickness or deep, partial-thickness burns that do not require surgery.
PI: J. Peter Rubin, MD
Description: Current effective dressings for burn wounds contain silver (nanoparticulate or ionic), hypochlorite, hydrogen peroxide, sulfa agents, chlorhexidine, iodine or other dilute antiseptics meant to provide some measure of antimicrobial protection. However, all of these materials have some proven limitations in facilitating wound healing and also have notable local and systemic adverse effects. None of the current clinical treatments enhance healing and/or reduce scar formation. The purpose of this study is to test the safety and effectiveness of SynePure™ Wound Cleanser when used in combination with Catasyn™ Advanced Technology Hydrogel for the treatment of superficial, partial-thickness or deep, partial-thickness burns (which may include “mixed”, “mixed partial burns” and/ or “mixed contiguous burns”) that do not require surgery.
This study is an investigator initiated, single site, University of Pittsburgh, prospective, parallel group, randomized controlled trial comparing SynePure Wound Cleanser and Catasyn Advanced Technology Hydrogel (intervention group) to the current gold standard treatment Silvadene (control group). Both groups will receive the same care other than the treating agent. Subjects will be recruited from the UPMC Mercy Burn Center adult patient pool who have sustained superficial, partial-thickness or deep, partial-thickness burns that do not require surgery, that comprise ≤10% of total body surface area (TBSA).
Primary & Secondary Objectives: Primary Objective: To test the effectiveness of SynePure Wound Cleanser when used in combination with Catasyn Advanced Technology Hydrogel for the treatment of superficial, partial-thickness or deep, partial-thickness burns (which include “mixed”, “mixed partial burns” and/ or “mixed contiguous burns”) wounds that do not require surgery as compared to standard of care treatment.
Secondary Objective: To test the ongoing safety of SynePure Wound Cleanser when used in combination with Catasyn Advanced Technology Hydrogel for the treatment of superficial, partial-thickness or deep, partial-thickness burns (which include “mixed”, “mixed partial burns” and/ or “mixed contiguous burns”) wounds that do not require surgery as compared to standard of care treatment.
Measurement/Outcomes: Primary Endpoint: Time to heal (re-epithelialization as defined by greater than or equal to 90% epithelialized wound): as measured by physical assessment, subjective patient scores (pain, itching, dryness, and irritation), investigator assessment of the wound photographs and participant assessment using the Patient and Observer Scar Assessment Scale.
Secondary Endpoints: Safety as measured by incidence of infection, progression of the wound to deep partial thickness requiring surgery/full thickness, any incidence of complications that would change the treatment course, and Vancouver scar scale score (pliability, pigmentation, height, vascularity of the wound).
Numbers of subjects to undergo intervention: 100
Title: A single center, randomized study to evaluate skin characteristics after facial autologous fat grafting to both sides of the face using saline washed or unwashed fat graft.
PI: J. Peter Rubin, MD
Description: The goal of this study is to specifically examine changes in facial skin appearance after facial fat grafting with autologous fat tissue that has either been washed with sterile saline before injecting, or left unwashed. This will be testing two variations of a standard of care surgical procedure, in two cohorts of subjects. One group will receive washed fat, and one group will receive unwashed fat, to both sides of the face. There are no experimental devices, drugs, or biological agents being used in this study. All fat tissue is autologous from the subjects treated.
Significance: This study will provide evidence that may directly impact clinical practice for a common procedure in plastic surgery. Regardless of whether the null hypotheses is accepted or rejected, the data will be of direct clinical use and impact practice in the operating room.
Primary & Secondary Objectives: Primary Objective: Evaluate changes in skin appearance between groups, including texture and pigmentation, following autologous fat grafting using two different preparations (washed versus unwashed).
Secondary Objectives: Assess the following outcomes following autologous fat grafting using two different preparations (washed versus unwashed).
- Assess rates of infection, local inflammation, and other adverse reactions between groups
- Compare the biological characterizations of the fat graft used between two preparations across subjects.
- Compare Patient Reported Outcomes between washed and unwashed groups
- Assess skin rejuvenation characteristics based on blinded expert grading of VISIA CR and VECTRA 3D images between washed and unwashed groups.
- Clinical assessment to include cutometer measurements of skin rejuvenation efficacy and questionnaires to include FWAS, SQA, SSA, SESS, GAIS and subject self-assessment will be used to assesses skin quality. (Baseline, Weeks 4, 12, 24, 36, and 52)
- Investigator’s overall assessment of fat grafting results, supported by blinded evaluator’s imaging assessments. (Baseline/pre fat graft injection, Weeks 4, 12, 24, 36, and 52)
- Safety: Safety will be assessed by recording Adverse Events, including cutaneous reactions (local intolerance), from the informed consent signature date until the end of the study.
Numbers of subjects to undergo intervention: 26
Title: Use of GID SVF-2 Device to Produce Autologous Adipose-Derived Stromal Vascular Fraction for Treatment of Osteoarthritis of the Knee: A Pivotal Medical Device Randomized Concurrent Controlled Study
PI: J. Peter Rubin, MD
Description: This study is a pivotal study to evaluate the efficacy and safety of a single injection of autologous adipose-derived SVF produced using the GID SVF-2 device system for treatment of pain with concomitant improvement in function associated with osteoarthritis of the knee joint.
Osteoarthritis affects over 30 million people in the United States and is the most common cause of disability. In the knee it can cause severe pain and increased stiffness, leading to reduced functionality and disability.
Primary & Secondary Objectives: Primary Objective: To evaluate the efficacy, using measures of pain and function, of a single injection of autologous adipose-derived SVF produced using the GID SVF-2 device system for treatment of pain with concomitant improvement in function associated with osteoarthritis of the knee joint.
Secondary Objective: To evaluate the safety of a single injection of autologous adipose-derived SVF produced using the GID SVF-2 device system for treatment of pain with concomitant improvement in function associated with osteoarthritis of the knee joint.
Measurement/Outcomes: The composite endpoint requires that each knee achieve pre-specified improvements in the WOMAC pain score and the WOMAC function score to achieve a success. The threshold for clinically important improvement for WOMAC pain is larger (≥ 55%, CII WOMAC Pain) because the primary indication for treatment is to reduce knee pain. In order for a knee to be considered a clinical success, the improvement in pain must have a concomitant minimum clinically important improvement in function (20%, MCII WOMAC Function).
The primary effectiveness evaluation is to test superiority of the active treatment relative to placebo using methods for comparing proportions between two groups. Primary efficacy endpoint is six months post treatment. Final endpoint for the study is 12 months.
Secondary Endpoint: Evaluation of Safety. Device, treatment and procedure related adverse event rates and severity will be summarized.
Numbers of subjects to undergo intervention At the University of Pittsburgh: 10
Title: Nano sensors for Wound Care Monitoring
PI: J. Peter Rubin, MD
Description: This proof of concept study is to determine whether a verifiable fingerprint can be determined in a diabetic foot ulcer (DFU) using Nano sensor technology guided by an artificial intelligence algorithm. Based off our animal model comparing malignant and non-malignant cells, we would expect to be able to develop an initial diabetic foot ulcer AI fingerprint using swabs collected from the DFU wounds of 10 participants.
Primary & Secondary Objectives: Hypothesis: The goal of the study is to test whether the AI can distinguish from the chemical fingerprint of the swabs, initially testing predicting non-chronic versus chronic for the AI’s initial yes/no question.
Secondary analysis: We will also have a technical testing question, whether there is any difference between the 2 swabs tested immediately on site at UPMC McKeesport the day of the consent/screening visit versus the 2 swabs tested back at Dr. Star’s Eberly Hall lab.
- Assessing whether a distinct, identifiable AI fingerprint can be determined from a swab of the diabetic foot ulcer’s cleaned wound.
- Assessing whether the AI can successfully identify the type of DFU wound (acute versus chronic) from the swabs collected, compared to the subject’s collected data.
Numbers of subjects to have swab collection: 10