[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 Date31 Oct 2024

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.

CTR20212051

/ CompletedPhase 1

单中心、随机、双盲、单次给药、剂量递增、安慰剂对照评价重组人血小板源生长因子凝胶（PDGF）在中国健康成年受试者中的安全性、耐受性Ⅰ期临床试验

[Translation] A single-center, randomized, double-blind, single-dose, dose-escalating, placebo-controlled phase I clinical trial to evaluate the safety and tolerability of recombinant human platelet-derived growth factor gel (PDGF) in healthy adult subjects in China

评价重组人血小板源生长因子凝胶单次给药对中国健康受试者的安全性、耐受性

[Translation]

To evaluate the safety and tolerability of a single dose of recombinant human platelet-derived growth factor gel in healthy Chinese subjects

Start Date23 Aug 2021

Sponsor / Collaborator

B&K Corporation Limited.

[+1]

100 Clinical Results associated with Recombinant Human Platelet-derived Growth Factor (Beijing Huaren Biotechnology)

100 Translational Medicine associated with Recombinant Human Platelet-derived Growth Factor (Beijing Huaren Biotechnology)

100 Patents (Medical) associated with Recombinant Human Platelet-derived Growth Factor (Beijing Huaren Biotechnology)

242

Literatures (Medical) associated with Recombinant Human Platelet-derived Growth Factor (Beijing Huaren Biotechnology)

01 Dec 2024·Clinical Advances in Periodontics

Human platelet‐derived growth factor‐BB (rhPDGF‐BB) with collagen matrix for sinus elevation without using a bone graft

Article

Author: Wang, Hom‐Lay ; Saleh, Muhammad H. A. ; Ghassib, Iya H.

AbstractBackgroundThis case report involves a 38‐year‐old male who presented to the clinic after experiencing complications from a tooth extraction, including a dislodged root segment in the sinus, a sinus wall fenestration on the palate, a residual bone height (RBH) of 3 mm, and inadequate healing of the soft tissue. He presented for implant placement.MethodsRecombinant human platelet‐derived growth factor‐BB (rh‐PDGF‐BB) was applied to a wound dressing material and placed in the sinus cavity alongside a 4.8 × 10 mm dental implant (Straumann SP, Straumann, Andover, MA, USA.). As documented in the literature, a graftless sinus lift via a lateral window was performed using a split‐thickness flap technique to elevate the sinus membrane, re‐establish its integrity, and restore its barrier function.ResultsAn 8‐month cone beam computed tomography assessment showed a 6.2 mm vertical bone gain and complete implant coverage.ConclusionThis approach provided a successful alternative to shorten treatment duration and achieve favorable radiographic outcomes during early healing.Key pointsThe use of rhPDGF‐BB and a collagen matrix in a sinus lift procedure emerges as a practical therapeutic option when grafting might lack predictability and notably consume more treatment time, while also achieving the desired bone height when used with a simultaneously placed implant.

01 Sep 2024·Cureus

The Impact of Socket Shield and Implant Surface Modification With Platelet-Derived Growth Factor on Osseointegration.

Article

Author: Thakare, Kaustubh ; Rathod, Aishwarya ; Parwani, Simran ; Kawadkar, Kshipra ; Jaiswal, Priyanka

Implants have become the first treatment option in the anterior esthetic region. Buccal bone loss is the sequalae of tooth extraction compromising osseointegration and cosmetic goals. The present case report is of a 47-year-old female who requested to have her fractured central incisor replaced with fixed restoration supported by an implant; the tooth had already undergone a root canal and lacked a sufficient structure for crown prosthesis placement. This case report evaluates the efficacy of the socket shield technique (SST) combined with a coating of recombinant human platelet-derived growth factor-BB (rhPDGF-BB) on the implant surface to achieve optimal biomechanical stability and esthetics.

01 Sep 2024·International Journal of Periodontics & Restorative Dentistry

The “Iceberg” Connective Tissue Graft Technique for Peri-implant Papilla Augmentation Following Interproximal Bone Reconstruction

Article

Author: Mancini, Leonardo ; Urban, Istvan ; Urban, Istvan A ; Wang, Hom-Lay ; Tavelli, Lorenzo ; Urban, Istvan A.

Implants with deficient papillae and black triangles are common findings. The treatment of these esthetic complications is considered to be challenging with limited predictability. Therefore, the present report aims to describe a novel technique for papilla augmentation: the 'iceberg' connective tissue graft (iCTG) after extraction and interproximal bone reconstruction in the anterior region. A 35-year-old patient presented with a hopeless tooth with interproximal clinical attachment loss extending to the apical third of the adjacent tooth. Interproximal bone reconstruction was performed through alveolar ridge preservation by directly applying recombinant human platelet-derived growth factor-BB (rhPDGF-BB) to the exposed root surface of the adjacent tooth. A mixture of autogenous bone chips (obtained from the ramus) and bovine bone xenograft particles (previously mixed with the growth factor) was also used. The patient was able to return for implant therapy only 2 years later, at which time an incomplete regeneration of the interproximal bone was observed. Therefore, to compensate the interproximal deficiency, the iCTG approach was utilized, involving a double layer of CTG with different origins. Two small grafts from the tuberosity were sutured to the mesial and distal ends of a wider CTG harvested from the palate, aiming to gain additional volume at the interproximal sites. The composite graft was then sutured on top of the implant platform, and the flap was then released and closed by primary intention. After conditioning the peri-implant tissues, the case was finalized with a satisfactory outcome. The described iCTG could be an effective approach for reconstructing peri-implant papillae following interproximal bone reconstruction.

100 Deals associated with Recombinant Human Platelet-derived Growth Factor (Beijing Huaren Biotechnology)

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetic foot ulcer	Phase 2	CN	B&K Corporation Limited.	31 Oct 2024
Diabetic foot ulcer	Phase 2	CN	Academy of Military Medical Sciences	31 Oct 2024

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