Clinical Development

A commitment to advancing novel therapies

Pipeline

Introducing NexoBrid®, a Biological Orphan Product for Debridement of Severe Thermal Burns

NexoBrid is a bromelain-based biological product containing a sterile mixture of proteolytic enzyme that selectively removes burn eschar within four hours without harming surrounding viable tissue.

NexoBrid is currently in phase 3 trials in the US with an expected US commercial approval between late 2020 and early 2021.

NexoBrid®

For more information on NexoBrid, please click here

NexoBrid is not currently approved for use in the U.S.

Clinical Trials

Cartilage Repair: Peak

Now recruiting for Clinical Trial PEAK (55-1702-1)

PEdiatric Autologous cultured chondrocytes treatment of cartilage defects in the Knee: A Study of MACI in Patients Aged 10 to ≤17 Years With Symptomatic Chondral or Osteochondral Defects of the Knee (PEAK).

Targets in Clinical Development: cartilage and osteochondral defects of the knee in Children and Adolescents

Cartilage and osteochondral defects of the knee occur along a spectrum of disease and severity. At one end of the spectrum are small, acute lesions that are often diagnosed incidentally at the time of knee arthroscopy and are not necessarily initially symptomatic. At the other end are larger lesions that are often symptomatic. These lesions can cause disabling symptoms such as pain, dysfunction, catching, locking, and swelling. Focal chondral lesions left untreated may progress to debilitating joint pain, dysfunction, and osteoarthritis.

The vast majority of chondral lesions occur in the adult population compared to children. In children, articular cartilage injuries that do not heal properly can result in long-term morbidity and can consume considerable healthcare resources. As in adults, cartilage injuries in the pediatric population result from various conditions. The most common pediatric cartilage injuries are associated with trauma and osteochondritis dissecans (OCD).

To learn more about clinical trials, visit ClinicalTrials.gov, a registry of federally and privately supported clinical trials conducted in the United States and around the world, or contact us with questions about our clinical development process.

PEAK (55-1702-1)

Status: Recruiting
Study Design: Prospective multicenter, randomized, open-label active controlled clinical trial
Patients: Patients aged 10 to ≤17 years with symptomatic articular chondral or osteochondral defects of the knee.
Purpose: Compare the efficacy and safety of MACI® vs arthroscopic microfracture.
Publications Based On Study: None

You may also view more complete information about this study (55-1702-1) on ClinicalTrials.gov, a registry of clinical trials conducted in the United States and around the world. Read the full study here >

Severe Burn: DETECT

Clinical Trial DETECT (NCT02148705)

A Study to Evaluate the Efficacy and Safety of NexoBrid in Subjects With Thermal Burns

Treatment of burns depends on the severity of the burn and the burn cause (etiology); for very severe burn, which results in dead tissue (eschar), debridement, or the removal of the eschar is one of the first and important steps of burn care. 

This study will be a three-arms study intending to demonstrate superiority of NexoBrid treatment over the Gel Vehicle placebo control treatment and over SOC in thermal burn subjects.

The study objectives are:

  • To demonstrate the efficacy of enzymatic eschar removal with NexoBrid by providing complete eschar removal as compared with Gel vehicle,
  • To demonstrate the efficacy of enzymatic eschar removal with NexoBrid by providing earlier complete eschar removal, reduction in patients’ surgical burden and its related blood loss as compared to SOC,
  • To assess the safety of NexoBrid compared to SOC, including demonstration that treatment with NexoBrid does not cause an unacceptable level of harm on wound closure outcome and long term outcomes of cosmesis and function. 

To learn more about clinical trials, visit ClinicalTrials.gov, a registry of federally and privately supported clinical trials conducted in the United States and around the world, or contact us with questions about our clinical development process.

DETECT (NCT02148705)

Status: Active
Study Design: Multicenter, Multinational, Randomized, Controlled, Assessor Blinded Study
Patients: Adult patients with thermal burns caused by fire/flame, scalds or contact with a total burn area ≥3% DPT and/or FT and ≤30% TBSA; SPT, DPT and/or FT in depth
Purpose: Evaluate the efficacy and safety of NexoBrid compared to gel vehicle and compared to standard of case
Publications Based On Study: None

You may also view more complete information about this study (NCT02148707) on ClinicalTrials.gov, a registry of clinical trials conducted in the United States and around the world. Read the full study here >

Severe Burn: CIDS

Now recruiting for Clinical Trial CIDS (NCT02278718)

A Study to Evaluate the Efficacy and Safety of NexoBrid in Children With Thermal Burns Compared to the Standard of Care

Treatment of burns depends on the severity of the burn and the burn cause (etiology); for very severe burn, which results in dead tissue (eschar), debridement, or the removal of the eschar is one of the first and important steps of burn care. 

This study will be a two-arms study intending to demonstrate superiority of NexoBrid treatment over SOC in children with thermal burns. The study objective is to evaluate the safety and clinical benefit of NexoBrid in hospitalized children (0-17 years) with deep partial and/or full thickness thermal burns of 1-30% TBSA and to compare NexoBrid to standard of care (SOC). 

To learn more about clinical trials, visit ClinicalTrials.gov, a registry of federally and privately supported clinical trials conducted in the United States and around the world, or contact us with questions about our clinical development process.

CIDS (NCT02278718)

Status: Recruiting
Study Design: Multicenter, Multinational, Randomized, Controlled, Open Label Study
Patients: Pediatric patients with thermal burns caused by fire/flame, scalds or contact with a total burns area ≥1% DPT and/or FT and ≤30% TBSA; SPT, DPT and/or FT in depth
Purpose: Demonstrate superiority over standard of care for eschar removal
Publications Based On Study: Rosenberg L, Krieger Y, Bogdanov-Berezovski A, Silberstein E, Shohom Y, Singer AJ. A novel rapid and selective enzymatic debridement agent for burn wound management: a multi-center RCT. Burns. 2014 May;40(3):466-74.

You may also view more complete information about this study (NCT02278718) on ClinicalTrials.gov, a registry of clinical trials conducted in the United States and around the world. Read the full study here >

Clinical & Scientific Publications

Cartilage Repair

MACI Pivotal Clinical Studies: Journal Articles and Abstracts

Matrix-Applied Characterized Autologous Cultured Chondrocytes Versus Microfracture: Five-Year Follow-up of a Prospective Randomized Trial. Brittberg M, Recker D, Ilgenfritz J, Saris D on behalf of the SUMMIT Extension Study Group. Am J Sports Med 2018;46(6):1343-1351.

Matrix-Applied Characterized Autologous Cultured Chondrocytes Versus Microfracture: Two-Year Follow-up of a Prospective Randomized Trial. Saris D, Price A, Brittberg M on behalf of the SUMMIT study group. Am J Sports Med 2014;42(6):1384-94.

SUMMIT Extension: Matrix-induced autologous chondrocyte implant vs microfracture at three years. Saris D, Price A, Yu Q, Kili S, Brittberg M. American Academy of Orthopaedic Surgeons 2015 Annual Meeting, March 24-28.

MACI Preclinical and Histology Studies

Matrix-Induced Autologous Chondrocyte Implantation (MACI) Using a Cell-Seeded Collagen Membrane Improves Cartilage Healing in the Equine Model. Alan J. Nixon, BVSc, MS, Holly D. Sparks, DVM, Laila Begum, PhD, Sean McDonough, DVM, PhD, Michael S. Scimeca, MS, Nance Moran, PhD, and Gloria L. Matthews, DVM, PhD. Journal of Bone and Joint Surgery, 2017; 99(23):1987-1998 

Matrix-induced autologous chondrocyte implantation (MACI) biological and histological assessment. Zheng MH, Willers C, Kirilak I, Yates P, Xu J, Wood D, Shimmin A.  Tissue Eng. 2007;13:737-746.

Rehabilitation Studies

A Prospective, Randomized Comparison of Traditional and Accelerated Approaches to Postoperative Rehabilitation following Autologous Chondrocyte Implantation: 2-Year Clinical Outcomes. Ebert JR, Robertson WB, Lloyd DG, Zheng MH, Wood DJ, Ackland T. Cartilage. 2010;1(3):180-187.

Clinical and magnetic resonance imaging-based outcomes to 5 years after matrix-induced autologous chondrocyte implantation to address articular cartilage defects in the knee. Ebert JR, Robertson WB, Woodhouse J, Fallon M, Zheng MH, Ackland T, Wood DJ. Am J Sports Med. 2011;39(4):753-63.

A randomized trial comparing accelerated and traditional approaches to postoperative weightbearing rehabilitation after matrix-induced autologous chondrocyte implantation: findings at 5 years. Ebert JR, Fallon M, Zheng MH, Wood D, Ackland T.  Am J Sports Med. 2012;40(7):1527-1537.

Two-year outcomes of a randomized trial investigating a 6-week return to full weightbearing after matrix-induced autologous chondrocyte implantation. Ebert JR, Edwards PK, Fallon M, Ackland TR, Janes GC, Wood DJ. Am J Sports Med. 2017;45(4):838-848.

Accelerated weightbearing rehabilitation after MACI in the tibiofemoral joint. Edwards PK, Ackland T, Ebert J. Am J Sports Med.2013;41(10):2314--24.

Is delayed weightbearing after MACI in the knee associated with better outcomes? A systemic review of Level 1 Evidence. Kraeutler M, Belk J, Carver T, McCarty E. Orthop J Sports Med. 2018 6(5). DOI: 10.1177/2325967118770986.

MACI Treatment for Patellofemoral Defects

A Comparison of 2-year Outcomes in Patients Undergoing Tibiofemoral or Patellofemoral Matrix-Induced Autologous Chondrocyte Implantation. Ebert JR, Schneider A, Fallon M, Wood DJ, Janes GC. Am J Sports Med 2017; 45(14): 3243-3253.

Prospective clinical and radiologic evaluation of patellofemoral matrix-induced autologous chondrocyte implantation. Ebert JR, Fallon M, Smith A, Janes GC, Wood DJ. Am J Sports Med 2015; 43(6) 1362-72.

Matrix-induced autologous chondrocyte implantation (MACI) for chondral defects in the patellofemoral joint. Meyerkort D, Ebert JR, Ackland TR, Robertson WB, Fallon M, Zheng MH, Wood DJ. Knee Surg Sports Traumatol Arthrosc 2014;22(1):2522-30.

Additional MACI publications

Matrix-induced autologous chondrocyte implantation versus microfracture in the treatment of cartilage defects of the knee: a 2-year randomised study. Basad E, Ishaque B, Bachmann G, et al. Knee Surg Sports Traumatol Arthrosc 2010; 18(4):519-27.

Clinical and radiological outcomes 5 years after matrix-induced autologous chondrocyte implantation in patients with symptomatic, traumatic chondral defects. Marlovits S, Aldrian S, Wondrasch B, Zak L, Albrecht C, Welsch G, Trattnig S. Am J Sports Med. 2012 40(10):2273-80.

Matrix-Associated Autologous Chondrocyte Implantation: A Clinical Follow-Up at 15 Years. Gille J, Behrens P, Schulz AP, Oheim R, Kienast B. Cartilage 2016;(4):309-15.

Matrix-associated autologous chondrocyte transplantation/implantation (MACT/MACI)-5 year follow-up. Behrens P, Bitter T, Kurz B, Russlies M. The Knee 2006;13(3):194-202.

Epidemiology, Progression and Morbidity of Cartilage Defects

Articular cartilage defects in 1,000 knee arthroscopies. Hjelle K, Solheim E, Strand T. Muri R, Brittberg M. Arthroscopy 2002;18(7):730-4. 

Focal Cartilage Defects in the Knee Impair Quality of Life as Much as Severe Osteoarthritis: A Comparison of Knee Injury and Osteoarthritis Outcome Score in 4 Patient Categories Scheduled for Knee Surgery. Heir S, Nerhus T, Ratterud J. Am J Sports Med2010; 38(2) 231-7.

Do focal chondral defects of the knee increase the risk for progression to osteoarthritis? A review of the literature. Houck D, Kraeutler MJ, Belk JW, Frank RM, McCarty EC, Bravman JT. Orthop J Sports Med 2018;6(10) 2325967118801931. doi: 10.1177/2325967118801931

An overview of autologous chondrocyte implantation. Gikas PD, Bayliss L, Bentley G, Briggs TW. J Bone Joint Surg Br. 2009;91(8):997-1006.

Severe Burns

Epicel Journal Articles

Twenty-Five Years’ Experience and Beyond with Cultured Epidermal Autografts for Coverage of Large Burn Wounds in Adult and Pediatric Patients, 1989-2015. W. Hickerson, MD, FACS, A. Remmers, PhD, DP Recker, MD. J Burn Care Res 2019 Feb 20;40(2)

Cultured skin for massive burns: A prospective, controlled trial. Munster A. Reprinted from the Annals of Surgery 1996; 224(3): 372-377.

Epicel Presentations and Posters

Cultured Epidermal Autografts (CEA) for Coverage of Large Burn Wounds in Pediatric and Adult Patients, 1989-2015. W. Hickerson, MD, FACS, T McKeen, J Fisher. 49th Annual Meeting of the American Burn Association (ABA), March 23, 2017.

NexoBrid Journal Articles

A novel rapid and selective enzymatic debridement agent for burn wound management: a multi-center RCT. Rosenberg L, Krieger Y, Bogdanov-Berezovski A, Silberstein E, Shoham Y, Singer AJ. Burns. 2014 May;40(3):466-74.

An Overview of the Use of Bromelain-Based Enzymatic Debridement (Nexobrid®) in Deep Partial and Full Thickness Burns: Appraising the Evidence. Loo YL, Goh BKL, Jeffery S. J Burn Care Res. 2018 Oct 23;39(6):932-938.

Time to start putting down the knife: A systematic review of burns excision tools of randomised and non-randomised trials.Edmondson SJ, Ali Jumabhoy I, Murray A. Burns. 2018 Nov;44(7):1721-1737.

Minimally invasive burn care: a review of seven clinical studies of rapid and selective debridement using a bromelain-based debriding enzyme (Nexobrid®). Rosenberg L, Shoham Y, Krieger Y, Rubin G, Sander F, Koller J, David K, Egosi D, Ahuja R, Singer AJ. Ann Burns Fire Disasters. 2015 Dec 31;28(4):264-274.

Enzymatic debridement for the treatment of severely burned upper extremities - early single center experiences. Cordts T, Horter J, Vogelpohl J, Kremer T, Kneser U, Hernekamp JF. BMC Dermatol. 2016 Jun 24;16(1):8.

The entity of thermal-crush-avulsion hand injury (hot-press roller burns) treated with fast acting debriding enzymes (nexobrid): literature review and report of first case. Di Castri A, Quarta L, Mataro I, Riccardi F, Pezone G, Giordano L, Shoham Y, Rosenberg L, Caleffi E. Ann Burns Fire Disasters. 2018 Mar 31;31(1):31.

Feasibility and safety of enzymatic debridement for the prevention of operative escharotomy in circumferential deep burns of the distal upper extremity. Fischer S, Haug V, Diehm Y, Rhodius P, Cordts T, Schmidt VJ, Kotsougiani D, Horter J, Kneser U, Hirche C. Surgery. 2019 Jan 21. pii: S0039-6060(18)30799-2.

Efficacy of enzymatic debridement of deeply burned hands. Krieger Y, Bogdanov-Berezovsky A, Gurfinkel R, Silberstein E, Sagi A, Rosenberg L. Burns. 2012 Feb;38(1):108-12.

Bromelain-based enzymatic debridement and minimal invasive modality (mim) care of deeply burned hands. Krieger Y, Rubin G, Schulz A, Rosenberg N, Levi A, Singer AJ, Rosenberg L, Shoham Y. Ann Burns Fire Disasters. 2017 Sep 30;30(3):198-204.

Selectivity of a bromelain based enzymatic debridement agent: A porcine study. Rosenberg L, Krieger Y, Silberstein E, Arnon O, Sinelnikov IA, Bogdanov-Berezovsky A, Singer AJ. Burns. 2012 Nov;38(7):1035-1040.

Enzymatic debridement of deeply burned faces: Healing and early scarring based on tissue preservation compared to traditional surgical debridement. Schulz A, Fuchs PC, Rothermundt I, Hoffmann A, Rosenberg L, Shoham Y, Oberländer H, Schiefer J. Burns. 2017 Sep;43(6):1233-1243.

The effects of rapid enzymatic debridement of deep partial-thickness burns with Debrase on wound reepithelialization in swine. Singer AJ, Taira BR, Anderson R, McClain SA, Rosenberg L. J Burn Care Res. 2010 Sep-Oct;31(5):795-802.

Reepithelialization of mid-dermal porcine burns after rapid enzymatic debridement with Debrase®. Singer AJ, Taira BR, Anderson R, McClain SA, Rosenberg L. J Burn Care Res. 2011 Nov-Dec;32(6):647-53.

Grants

Vericel is committed to improving the lives of patients with serious conditions by developing and manufacturing advanced cell therapies and specialty biologics. As part of this mission, Vericel is proud to support our orthopedic and burn surgeons and their patients through grants for research (investigator-sponsored trials), education, or donations to charitable entities.

Each grant request is evaluated on its individual merit. Please be advised that applications for grants may not be submitted via sales personnel, and sales personnel are not permitted to discuss pending applications. Submission of a grant proposal does not imply or guarantee approval. Please do not consider any request approved until you have received written documentation from Vericel.

Investigator-Sponsored Trials and Investigatory Initiated Studies

Vericel is committed to supporting investigator-sponsored trials (IST) for the advancement of scientific and medical knowledge of our products. Each IST is carefully evaluated on a competitive basis, taking into account scientific rigor, methodological considerations, and patient safety.

To submit an application: download and complete the Application for Investigator Sponsored Trial and then click the “Email” button at the top which will automatically generate an email to [email protected]

Education Grants

Vericel may provide financial support for valid healthcare professional educational activities organized by legitimate third-party organizations with educational missions.

To submit an application: download and complete the Application for Educational Grant and then click the “Email” button at the top which will automatically generate an email to [email protected]

Charitable Donations

To support a recipient’s legitimate charitable mission, Vericel may provide charitable donations in the form of financial or in-kind support to qualified 501(c)(3) nonprofits or similar charitable organizations.

To submit an application: please send a letter of request to [email protected]

NASDAQ: VCEL

$15.45 -0.05 (-0.32%)
Day High: $15.66
Day Low: $15.36
Volume: 258573
4:00 PM on
October 18, 2019
Copyright West LLC. Minimum 15 minutes delayed.

Company Presentation