StrataGraftDeep partial-thickness thermal burns in adults
New molecular entity
Development and Regulatory status
Jun 21Approved in the US 
Feb 21FDA review of StrataGraft in the US delayed as COVID-19 travel restrictions forced the delay of a manufacturing plant inspection .
Oct 20According to its latest annual report, StrataGraft is one of the company ´s most significant products in its pipeline. Plans for filing in jurisdictions other than the US are not, however, discussed .
Oct 20Mallinckrodt says the restructuring will enable the company to move ahead with its strategic plans, although these plans were not explicitly communicated .
Oct 20Mallinckrodt files for Chapter 11 bankruptcy amid growing lawsuits that allege the company has participated in fueling the opioid epidemic in the US. Mallinckrodt said it is seeking this option to restructure their debt. All US subsidiaries of Mallinckrodt will continue to operate during the proceedings, including work to supply customers and patients with its pharmaceutical products. Stratatech is a Mallinckrodt company .
Aug 20FDA accepts the BLA of StrataGraft and grants priority review, setting a PDUFA bill date of 2 February 2021 .
Jun 20Stratatech completes the rolling submission of the Biologics License Application (BLA) to the US FDA which was initiated in April 2020. The submission was based on the results from the pivotal PIII STRATA2016 trial and the STRATA2011 trial [1,2].
Jul 17US FDA grants Regenerative Medicine Advanced Therapy (RMAT) designation to StrataGraft. Also has orphan drug status in US for treatment of partial and full thickness burns .
A living, full thickness, human skin replacement produced using the NIKS® human keratinocyte progenitor cell line technology. Grown in vitro on a collagen matrix embedded with human fibroblasts, forms a full thickness human skin with normal architecture
Approximately 130,000 people with burn injuries visit Emergency Departments (ED) each year and approximately 10,000 are admitted to hospital. Of these, approximately 500 are admitted to hospital with severe burn injuries which require fluid-resuscitation. Approximately half of these are children under 16 years of age .
Deep partial-thickness thermal burns in adults
Trial or other data
Apr 21PIII STRATA2016 trial results published in Burns journal. 71 patients were enrolled. By month 3 (M3), there was a 96% reduction in mean percent area of StrataGraft treatment sites that required autografting, compared with autograft treatment sites (4.3% vs 102.1%, respectively). StrataGraft treatment resulted in durable wound closure at M3 without autografting in 92% (95% CI: 85.6, 98.8; n/n 59/64) of patients for whom data were available. The most common StrataGraft-related adverse event was pruritus (15%) .
Aug 20Autograft is considered to be a standard of care by many for deep partial-thickness thermal burns. It involves the surgical harvesting of healthy skin tissue from an uninjured site on the patient and transplanting the skin graft to the injury. While this process can be effective in providing closure of the original wound, it has significant limitations related to the donor site wounds created during surgical removal of the skin tissue for grafting. Donor site wounds are painful and can create risks of additional scarring and infection. In addition, the amount of healthy skin available for harvesting is frequently limited in those patients with large burns, necessitating sequential re-harvesting of available donor sites. As a result, there is a need for alternatives to donor site harvesting for the treatment of severe burns .
Mar 20Stratatech completes the pivotal PIII STRATA2016 trial .
Jan 20Stratatech terminates a PII trial due to protracted enrolment and limited efficacy in the first three patients (STRATA2014) .
Sep 19Stratatech announces that the pivotal PIII STRATA2016 trial met both co-primary endpoints with high statistical significance, demonstrating autograft sparing and durable wound closure at three months with human skin replacement .
May 17PII trial to evaluate the safety, tolerability and efficacy of single or multiple applications of StratGraft as an alternative to autografting full-thickness complex skin defects, to promote healing of skin burns and wounds starts (STRATA2014; W81XWH-16-C-0202; NCT03005054) .
May 17Pivotal PIII STRATA2016 trial to evaluate the safety and efficacy of StrataGraft skin tissue for promotion of autologous skin tissue regeneration of complex skin defects due to thermal burns starts (STRATA2016; NCT03005106). It will enrol 71 patients in the US. The trial is part of a larger, five-year contract with the United States Biomedical Advanced Research and Development Authority (BARDA) .
Oct 14PIb study (NCT01437852) completes .
Jan 13Positive top-line results from 20 patients reported from the PIb trial of StrataGraft (NCT01437852) .
Sep 11PIb trial of StrataGraft in patients with deep partial-thickness burns starts (STRATA2011; NCT01437852). The randomised, open-label trial, conducted in collaboration with the US Department of Defense Armed Forces Institute of Regenerative Medicine, will enrol 30 patients with severe second-degree burns which require surgical excision and autografting. The patients were sequentially enrolled in three cohorts of increasing treatment area receiving StrataGraft. The primary outcome measure was wound closure at three months .
Apr 08PI/II trial completes. Stratatech collaborated with the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) to conduct the trial of StrataGraft in patients with complex skin wounds (full skin thickness) requiring sequential debridement with temporary biological dressing (allogeneic grafting) prior to autografting (NCT00618839). A total of 15 patients were randomised to receive StrataGraft or cadaver skin. Positive results have been published .