[Translation] A multicenter, randomized, double-blind, placebo-controlled phase II clinical study to evaluate the preliminary efficacy and safety of recombinant human platelet-derived growth factor gel (rhPDGF-BB) in patients with diabetic foot ulcers

评价试验药物在糖尿病足溃疡受试者中的初步有效性和安全性

[Translation]

To evaluate the preliminary efficacy and safety of the investigational drug in subjects with diabetic foot ulcers

Start Date-

Sponsor / Collaborator

B&K Corporation Limited.

[+1]

CTR20233683 / RecruitingPhase 2

一项评价重组人血小板源生长因子（rhPDGF-BB）凝胶在皮肤局部（浅/深）Ⅱ度烧伤患者的有效性和安全性的多中心、随机、双盲、安慰剂对照的Ⅱb期临床研究

[Translation] A multicenter, randomized, double-blind, placebo-controlled phase IIb clinical study to evaluate the efficacy and safety of recombinant human platelet-derived growth factor (rhPDGF-BB) gel in patients with partial (superficial/deep) second-degree burns of the skin

评价试验药物在（浅/深）Ⅱ度烧伤受试者中的有效性和安全性

[Translation]

To evaluate the efficacy and safety of the experimental drug in subjects with (shallow/deep) second-degree burns

Start Date04 Dec 2023

Sponsor / Collaborator

B&K Corporation Limited.

CTR20221760 / CompletedPhase 2

一项评价重组人血小板源生长因子凝胶（rhPDGF-BB）在皮肤局部（浅/深）Ⅱ度烧伤患者的安全性、耐受性、初步有效性和药代动力学的多中心、随机、双盲、安慰剂对照的Ⅱa期临床研究

[Translation] A multicenter, randomized, double-blind, placebo-controlled phase IIa clinical study to evaluate the safety, tolerability, preliminary efficacy and pharmacokinetics of recombinant human platelet-derived growth factor gel (rhPDGF-BB) in patients with partial (superficial/deep) second-degree burns of the skin

评价试验药物在（浅/深）Ⅱ度烧伤受试者中的安全性、耐受性;初步评价试验药物在（浅/深）Ⅱ度烧伤受试者中的有效性；评价试验药物在（浅/深）Ⅱ度烧伤受试者中的药代动力学特征及免疫原性。

[Translation]

To evaluate the safety and tolerability of the trial drug in subjects with (shallow/deep) second-degree burns; to preliminarily evaluate the efficacy of the trial drug in subjects with (shallow/deep) second-degree burns; to evaluate the pharmacokinetic characteristics and immunogenicity of the trial drug in subjects with (shallow/deep) second-degree burns.

Start Date17 Sep 2022

Sponsor / Collaborator

B&K Corporation Limited.

100 Clinical Results associated with Pro-101-1

100 Translational Medicine associated with Pro-101-1

100 Patents (Medical) associated with Pro-101-1

Literatures (Medical) associated with Pro-101-1

01 Mar 2007·Journal of Dermatological ScienceQ2 · MEDICINE

Recombinant human platelet-derived growth factor enhanced dermal wound healing by a pathway involving ERK and c-fos in diabetic rats

Q2 · MEDICINE

Article

Author: Zhi-Yong Sheng ; Biao Cheng ; Tong-Zhu Sun ; Hong-Wei Liu ; Xiao-Bing Fu

BACKGROUNDPlatelet-derived growth factor (PDGF) has been shown to promote dermal wound healing, however, the molecular mechanisms responsible for are not fully understood.OBJECTIVEThe present study was undertaken to investigate the possible signaling mechanisms by which PDGF improved healing of cutaneous wound in diabetic rats.METHODSFour full-thickness skin wounds were created on the dorsum of Wistar diabetic rats. Animals were treated with or without recombinant human PDGF (rhPDGF) at 7.0 microg/cm(2) wound or vehicle daily 1 day after wounding. The animals were then killed after various intervals of wounding, and the wounded skin tissues were used for histological evaluation, analysis of the phosphorylation of extracellular signal-regulated kinases (ERK) and the expression of c-fos protein, as well as the labeling indices of proliferative cell nuclear antigen (PCNA).RESULTSTopical application of rhPDGF significantly accelerated the rate of reepithelialization compared with vehicle-treated or untreated group at 7 days after wounding. At the histological level, the significant increases in the degree of reepithelialization, the thickness of granulation tissue and the density of capillary bud were observed in the wound sites in rhPDGF-treated group at 7 and 14 days after wounding. Moreover, treatment with rhPDGF increased PCNA labeling indices, c-fos protein expression and ERK phosphorylation in the wounded tissues at the indicated time after wounding.CONCLUSIONThese results suggest that application of rhPDGF increases cell proliferation, and enhances dermal tissue repair in diabetic skin lesion of rats, which might be partly mediated by ERK activation and c-fos protein expression.

01 Nov 2006·Zhongguo xiu fu chong jian wai ke za zhi = Zhongguo xiufu chongjian waike zazhi = Chinese journal of reparative and reconstructive surgery

Recombinant human platelet-derived growth factor enhances repair of cutaneous full-thickness excision by increasing the phosphorylation of extracellular signal-regulated kinase in diabetic rat.

Article

Author: Sheng, Zhiyong ; Fu, Xiaobing ; Liu, Hongwei ; Sun, Tongzhu ; Cheng, Biao

OBJECTIVETo investigate the possible signaling mechanisms by which recombinant human platelet-derived growth factor (rhPDGF) accelerated healing of cutaneous wound in diabetic rats.METHODSFour full-thickness skin wounds were incised in the back of 26 male Wistar diabetic rats. The wounded rats were divided into 3 groups (7 or 8 rats each group). One group without treatment was used as a control, and the other 2 groups were treated with rhPDGF at a dose of 7.0 microg/cm2 wound or vehicle (DMSO/0.9% NaCl, vol/vol 1:1) from 1 to 14 days. The wound healing was evaluated by the measurements of the wound volume and area. Immunofluorescent and immunohistochemical staining were used to examine the phosphorylation of extracellular signal-regulated kinase 1/2 (ERK1/2) and the expression of proliferative cell nuclear antigen (PCNA), respectively.RESULTSGranulation tissue appeared in the bed of wound after injury. The number of blood capillary buds and fibroblasts was greater in the rhPDGF-treated group than that in the other 2 groups. A lot of inflammatory cells infiltration and collagen deposition were observed in the wound. The wound-volume in the rhPDGF-treated group was smaller than that in control group (P < 0.05). The reepithelialization rate in rhPDGF-treated group was higher than that in the other 2 groups at 7 days after injury (P < 0.05). The expression of PCNA in reparative cells was higher in rhPDGF-treated group than in control group or vehicle-treated group at 3,7 days after injury (P < 0.05). The phosphorylation of ERK1/2 was stronger in rhPDGF-treated group than that in control group or vehicle group at 7 and 14 days after injury (P < 0.05).CONCLUSIONThese results suggest that rhPDGF accelerates wound healing and improves healing quality by increasing the phosphorylation of ERK1/2.

100 Deals associated with Pro-101-1

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Indication	Highest Phase	Country/Location	Organization	Date
Burns	Phase 2	CN	B&K Corporation Limited.	17 Sep 2022

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