Delving into the Latest Updates on HP-802247 with Synapse

Overview

Basic Info

Drug Type

Cell therapy

Synonyms

Allogeneic human skin replacement Smith Nephew Biotherapeutics, DFB Healthpoint allogeneic human skin replacement, Human skin replacement Smith Nephew Biotherapeutics

+ [2]

Target-

Mechanism

Fibrinogen replacements(Fibrinogen replacements), Tissue replacements

Therapeutic Areas

Skin and Musculoskeletal DiseasesOther Diseases

Active Indication-

Inactive Indication

Leg UlcerWounds and Injuries

Originator Organization

Healthpoint Ltd.

Active Organization-

Inactive Organization

Smith & Nephew Orthopaedics Ltd.

Drug Highest PhaseDiscontinuedPhase 3

First Approval Date-

Regulation-

This study is being done to find out if an investigational product called HP802-247 can help people with venous leg ulcers. Investigational means that HP802-247 has not been approved by the U.S. Food and Drug Administration (FDA).
This research is being done to compare the efficacy of HP802-247 plus compression therapy against Vehicle plus compression therapy in achieving complete wound closure over the 12-week treatment period. Vehicle looks the same as HP802-247 but contains no cells.
At least 440 subjects will participate. The study is going to be conducted in approximately 5 countries at approximately 50 sites across the European Union.

Start Date01 Nov 2013

Sponsor / Collaborator

HealthPoint

EUCTR2013-000949-39-BE / Not yet recruitingPhase 3

An Observational Study Providing 12 Months of Safety Follow-Up from First Exposure to HP802-247 in Subjects Who Participated in Study 802-247-09-032(EU)

Start Date20 Sep 2013

Sponsor / Collaborator

Smith & Nephew, Inc. (Canada)

100 Clinical Results associated with HP-802247

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100 Translational Medicine associated with HP-802247

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100 Patents (Medical) associated with HP-802247

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7

Literatures (Medical) associated with HP-802247

01 Dec 2019·Annals of Plastic SurgeryQ4 · MEDICINE

Cell-Based Therapies for Chronic Wounds Tested in Clinical Studies

Q4 · MEDICINE

Review

Author: Siemionow, Maria ; Krzyżanowska, Marta ; Domaszewska-Szostek, Anna

IntroductionTransplantation of the keratinocytes, fibroblasts, bone marrow, and adipose tissue–derived mesenchymal stem cells may improve chronic wound healing by delivery of different cytokines, chemokines, and growth factors, which play an essential role in wound healing. The purposes of this review were to check which cell lines are potentially beneficial in enhancement of wound healing and to describe the safety and efficacy of cell therapies in the clinical treatment of chronic wounds, as well as to summarize the pertinent literature and research progress in this field.MethodsPubMed search engine and ClinicalTrials.gov were used to analyze the available data on cell therapies applied in treatment of chronic wound. The analysis included 51 articles, assessing the use of keratinocytes (10), fibroblasts (7), keratinocytes and fibroblasts (10), bone marrow–derived cells (20), and adipose tissue cells (4). Studies on the cell-based products that are currently available on the market (Dermagraft, EpiDex, Apligraf, and HP802-247) were also included, with majority of reports found on fibroblasts and keratinocytes studies.ResultsCell-based therapies have a great potential to improve wound healing without major surgical procedures and donor-site morbidity. There is, however, a lack of guidelines on how the age of the patients, the general health conditions, and the coexistence of different diseases may affect the success of these therapies. Further studies are needed to determine the fate of transplanted cells and the number of cells required to obtain optimal effects and outcomes.ConclusionsDespite many promising clinical trials on application of various stem cell–based therapies for treatment of chronic wounds, there is still a need for multicenter comparative studies assessing the dose response and the cell source response on the efficacy of chronic wound healing.

01 Nov 2017·Journal of Vascular Surgery: Venous and Lymphatic DisordersQ3 · MEDICINE

Baseline factors affecting closure of venous leg ulcers

Q3 · MEDICINE

Article

Author: Sven Quist ; Lajos Kemeny ; Yadwinder S. Dhillon ; Kenneth K. Shimozaki ; Tomasz Zubilewicz ; Travis A. Motley ; Thomas Ruzicka ; Perry V. Mayer ; Caesar A. Anderson ; Kenneth B. Deck ; Paul B. Rock ; Alexander M. Reyzelman ; Petra Cetkovska ; Michael F. Moore ; Herbert B. Slade ; Lawrence Lavery ; Csaba Hajdu ; Stephanie C.S. Wu ; Wolfgang Vanscheidt ; Peter F. Lawrence ; Laszlo Lauf ; Charles A. Andersen ; Olga Filipovska ; Alik Farber ; Robert S. Kirsner ; Ian L. Gordon ; Dean Vayser ; Jaime E. Dickerson ; Jacek Mikosinski ; Eva Remenyik ; Douglas B. Hood ; Tomasz Grzela ; D. Innes Cargill ; Shawn M. Cazzell ; Radka Zimolova ; Jodi Walters ; J. Randolph Clements ; Vincent Giacalone ; Astrid Matejkova ; Joseph Cavorsi ; Emily A. Cook ; Juan C. Jimenez ; Eliot N. Mostow ; Petr Arenberger ; Michael Weichenthal ; John Tassone ; Steffen Emmert ; Marc A. Despatis ; Mher Vartivarian ; Robert D. Galiano ; Tobias George ; Holger Lawall ; Karry Ann Shebetka ; Joachim Dissemond ; Bernhard Homey ; Robert Galiano ; Pawel Swiercz ; Arlette De Conninck ; Sabine Eming ; Michael M. Molyneaux ; Hilde Beele ; Zbigniew Rybak ; David Stuchlik ; Robert G. Frykberg ; Istvan Varkonyi ; Roland Aschoff ; Joel J. Gagnon ; Edina Nemes ; Noemi Bakos ; Cyaandi Dove ; Michael Juenger ; Carl Van Gils ; An Bervoets ; Rita Rez ; Matthias Augustin ; Krystyna Twardowska-Saucha ; William A. Marston ; Jason R. Hanft ; Thomas Horn ; Marek Kotala ; Marian Simka ; George L. Enriquez ; Vladimir Vasku ; Marcin Malka ; Vera Pavlasova ; Markus Stuecker ; Paul J. Kim ; John C. Lantis ; William J. Ennis ; David H. Keast ; Sabine A. Eming ; Jonathan M. Zenilman

OBJECTIVEThe objective of this study was to characterize factors associated with closure of venous leg ulcers (VLUs) in a pooled analysis of subjects from three randomized clinical trials.METHODSClosure of VLUs after treatment with HP802-247, an allogeneic living cell therapy consisting of growth-arrested human keratinocytes and fibroblasts, vs standard therapy with compression bandaging was evaluated in three phase 3 clinical trials of similar design. Two trials enrolled subjects with VLUs ranging from 2 cm² to 12 cm² in area with 12-week treatment periods; the third trial enrolled subjects with VLUs between >12 cm² and ≤36 cm² with a 16-week treatment period. The first trial went to completion but failed to demonstrate a benefit to therapy with HP802-247 compared with placebo, and because of this, the remaining trials were terminated before completion. On the basis of no differences in outcomes between groups, subjects from both HP802-247 and control groups were pooled across all three studies. Cox proportional hazards regression analysis was employed to evaluate factors associated with VLU closure.RESULTSThis analysis included data from 716 subjects with VLU. Factors evaluated for association with healing included age, gender, race, diabetes, glycated hemoglobin level, body mass index, treatment (HP802-247 vs compression alone), and ulcer characteristics including location and area and duration at baseline. In an initial model including all of these putative factors, the following were significant at the P < .10 level: diagnosis of diabetes mellitus, gender, wound location (ankle or leg), baseline wound area, and wound duration at baseline. In a final model including only these factors, all but diabetes mellitus were significant at the P < .05 level. Effect sizes were as follows (hazard ratio [95% confidence interval]): female gender (1.384 [1.134-1.690]), wound location on the leg (1.490 [1.187-1.871]), smaller wound area at baseline (0.907 [0.887-0.927]), and shorter wound duration at baseline (0.971 [0.955-0.987]).CONCLUSIONSFactors associated with VLU lesions including location, area, and duration were important predictors of healing. Women were more likely than men to achieve wound closure. Factors including body mass index, the presence of diabetes mellitus, and higher concentrations of glycated hemoglobin were not significant independent predictors of wound closure in this analysis.

01 Sep 2013·Wound Repair and RegenerationQ3 · MEDICINE

Durability of healing from spray‐applied cell therapy with human allogeneic fibroblasts and keratinocytes for the treatment of chronic venous leg ulcers: A 6‐month follow‐up

Q3 · MEDICINE

Article

Author: Slade, Herbert B. ; Dickerson, Jaime E. ; Lee, Tommy D. ; Snyder, Robert J. ; Marston, William A. ; Cargill, D. Innes ; Zhang, Yuxin ; Kirsner, Robert S.

AbstractPatients who participated in a Phase 2 trial of HP802‐247 for venous leg ulcers were invited to participate in this 24‐week follow‐up study to assess the durability of healing, document additional ulcer closures, and evaluate posttreatment safety. Consent was given by 90% (206/228), with 80% (183/228) completing all visits. Blinding was retained from the previous trial in which subjects had been randomized to vehicle or one of four cell therapy regimens. Visits were every 8 weeks. Among the 183 subjects, 43% (21/49) previously treated with cells and entering follow‐up with an open wound achieved closure, compared with 35% (7/20) previously treated with vehicle, while 10% (11/106) and 17% (3/18), respectively, experienced reopening of a previously closed wound. Subjects previously treated with cells closed more open wounds than those previously treated with vehicle (OR 1.39, 95% CI 0.47–4.10; p = 0.739), and less subjects with a previously closed wound reopened (OR 0.65, CI 0.16–2.60; p = 0.821); however, these findings were not statistically significant. At the final visit, the difference in proportion of subjects with wounds closed continued to favor the best dose from the prior trial (83% closed vs. 58%, delta 25%). Follow‐up beyond 12 weeks is necessary to evaluate the full benefit of this therapy, as treatment with cells may provide stimulus toward healing that persists for up to several weeks following the last application. The results show that the greater proportional benefit achieved by HP802‐247 relative to standard care after 12 weeks of treatment persists over a meaningful timeframe.

100 Deals associated with HP-802247

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Leg Ulcer	Phase 3	DE	Smith & Nephew Orthopaedics Ltd.	-
Leg Ulcer	Phase 3	CA	Smith & Nephew Orthopaedics Ltd.	-
Leg Ulcer	Phase 3	PL	Smith & Nephew Orthopaedics Ltd.	-
Leg Ulcer	Phase 3	US	Smith & Nephew Orthopaedics Ltd.	-
Leg Ulcer	Phase 3	PR	Smith & Nephew Orthopaedics Ltd.	-
Leg Ulcer	Phase 3	BE	Smith & Nephew Orthopaedics Ltd.	-
Leg Ulcer	Phase 3	CZ	Smith & Nephew Orthopaedics Ltd.	-
Leg Ulcer	Phase 3	HU	Smith & Nephew Orthopaedics Ltd.	-
Wounds and Injuries	Phase 3	US	Smith & Nephew Orthopaedics Ltd.	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01737762 (CTgov)	Phase 3	Varicose Ulcer	155	HP802-247 (HP802-247)	uvnesdncwd(uitobdwykc) = tvzkpykzmu qckrbprjvp (jnlbpanxwz, nykvzhecay - wqmtxftown) View more	-	26 Jul 2017
				Vehicle (Vehicle)	uvnesdncwd(uitobdwykc) = qyycaggnor qckrbprjvp (jnlbpanxwz, qhjqdzzznf - trwhvpnlyr) View more
NCT01359735 (CTgov)	Phase 2	Skin Neoplasms	8	HP802-247 (HP802-247)	xjnaajzzyk(ceogwcsdft) = knstqnppwz qjjirzgqvj (hlhfqlpctc, awhqnwfhle - xmedafmhwh) View more	-	29 Jun 2017
				Bacitracin Ointment (Bacitracin Ointment)	xjnaajzzyk(ceogwcsdft) = insexqzvps qjjirzgqvj (hlhfqlpctc, cntsvusgpe - cqgiktysal) View more
NCT02154087 (MOA 034, CTgov)	Phase 2	Varicose Ulcer	1	HP802-247	fgzkldowqg(oijctmkdhs) = yqzjollkna ocihmgxsjl (ahdcrgosfw, maqykocgup - ayxxzrewvy) View more	-	03 Oct 2016
NCT01853384 (CTgov)	Phase 3	Varicose Ulcer \| Ulcer	252	HP802-247 (HP802-247 Plus Compression Therapy)	ktywevkgbc(yhdyqruqyb) = sevxioibos igxksqhhiv (uuzdhbzxtl, qntbctflmp - njgxljxgdo) View more	-	03 Oct 2016
				HP802-247 Vehicle (HP802-247 Vehicle Plus Compression Therapy)	ktywevkgbc(yhdyqruqyb) = xuipdiowjc igxksqhhiv (uuzdhbzxtl, ktvsnjrnji - zstfjdekfo) View more
NCT00852995 (CTgov)	Phase 2	Varicose Ulcer	228	HP802-247 (B - Low Q14D)	mgxxrnsinf(bdqvtaugwr) = npphginvoi dfeamonduv (cpsixhanll, vwnkyoznbi - jbxsobwbtk) View more	-	14 Mar 2016
				HP802-247 (A - Low Q7D)	mgxxrnsinf(bdqvtaugwr) = okfsgqdmyi dfeamonduv (cpsixhanll, buxzldnzpo - tgbhxrcwet) View more
NCT01656889 (CTgov)	Phase 3	Varicose Ulcer	447	HP-802-247 (HP802-247)	xqszfydqgf(ilkqhobwux) = wpncrbljxc lvcthekwyq (eaqrqdssqe, bheebnprjz - amygyzvkkj) View more	-	14 Mar 2016
				Vehicle (Vehicle)	xqszfydqgf(ilkqhobwux) = cxertkqgos lvcthekwyq (eaqrqdssqe, awshahotsa - kmadxailjd) View more