Last update 01 Nov 2024

Piramal Healthcare (Canada) Ltd.

Subsidiary Company|

Canada

Subsidiary Company|

Canada

Last update 01 Nov 2024

Overview

Pipeline

Deal

Translational Medicine

Overview

Clinical Trials associated with Piramal Healthcare (Canada) Ltd.

NCT02981355 / TerminatedPhase 4

Randomized Evaluation of BST-CarGel Versus Microfracture Alone On Recovery From Distal Femoral Cartilage Lesions

This multi-centre randomized, controlled trial will assess the impact of BST-CarGel scaffold with microfracture versus microfracture alone on short and long term clinical benefit in patients with cartilage lesions of the femoral condyle requiring operative management.

Start Date26 Jul 2017

Sponsor / Collaborator

Piramal Healthcare (Canada) Ltd.

[+1]

NCT01246895 / CompletedNot Applicable

Follow-up Study Evaluating The Long-Term Safety and Efficacy of BST-CarGel® and Microfracture In Repair of Focal Articular Cartilage Lesions on The Femoral Condyle (Extension Study of Protocols CG-CIP01-P & CG-CIP02-P)

This follow-up study will evaluate the effects of BST-CarGel® application to a microfractured lesion (investigational) and microfracture alone (control) for up to 5 years from treatment in subjects, treated under Protocols CG-CIP01-P and CG-CIP02-P, and will serve as a post approval study for these Protocols, in support of a commercial application. The lesions treated under Protocols CG-CIP01-P and CG-CIP02-P were focal lesions of articular cartilage, grade 3 or 4 (either ICRS or Outerbridge classification) on the medial and lateral femoral condyles of the knee, and were classified as either acute or chronic.

Start Date01 Mar 2011

Sponsor / Collaborator

Piramal Healthcare (Canada) Ltd.

NCT00314236 / CompletedNot Applicable

A Randomized, Comparative Multicenter Clinical Trial Evaluating BST-CarGel™ and Microfracture in Repair of Focal Articular Cartilage Lesions on the Femoral Condyle

This study will investigate whether the treatment of damaged cartilage in the knee with BST-CarGel will increase the amount and quality of cartilage repair tissue when compared with microfracture alone. Furthermore, the effect of BST-CarGel in decreasing cartilage related pain and improving cartilage-related function in the knee will be assessed.

Start Date01 Dec 2005

Sponsor / Collaborator

Piramal Healthcare (Canada) Ltd.

100 Clinical Results associated with Piramal Healthcare (Canada) Ltd.

0 Patents (Medical) associated with Piramal Healthcare (Canada) Ltd.

Literatures (Medical) associated with Piramal Healthcare (Canada) Ltd.

01 Apr 2015·CARTILAGEQ3 · MEDICINE

BST-CarGel® Treatment Maintains Cartilage Repair Superiority over Microfracture at 5 Years in a Multicenter Randomized Controlled Trial

Q3 · MEDICINE

Article

Author: Shive, Matthew S. ; Méthot, Stéphane ; Mohtadi, Nicholas ; Restrepo, Alberto ; Stanish, William D. ; Forriol, Francisco ; Desnoyers, Jacques ; Pelet, Stéphane ; Vehik, Kendra ; McCormack, Robert

Objective The efficacy and safety of BST-CarGel®, a chitosan scaffold for cartilage repair was compared with microfracture alone at 1 year during a multicenter randomized controlled trial in the knee. This report was undertaken to investigate 5-year structural and clinical outcomes. Design The international randomized controlled trial enrolled 80 patients, aged 18 to 55 years, with grade III or IV focal lesions on the femoral condyles. Patients were randomized to receive BST-CarGel® treatment or microfracture alone, and followed standardized 12-week rehabilitation. Co-primary endpoints of repair tissue quantity and quality were evaluated by 3-dimensional MRI quantification of the degree of lesion filling (%) and T2 relaxation times. Secondary endpoints were clinical benefit measured with WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) questionnaires and safety. General estimating equations were used for longitudinal statistical analysis of repeated measures. Results Blinded MRI analysis demonstrated that BST-CarGel®-treated patients showed a significantly greater treatment effect for lesion filling ( P = 0.017) over 5 years compared with microfracture alone. A significantly greater treatment effect for BST-CarGel® was also found for repair tissue T2 relaxation times ( P = 0.026), which were closer to native cartilage compared to the microfracture group. BST-CarGel® and microfracture groups showed highly significant improvement at 5 years from pretreatment baseline for each WOMAC subscale ( P < 0.0001), and there were no differences between the treatment groups. Safety was comparable for both groups. Conclusions BST-CarGel® was shown to be an effective mid-term cartilage repair treatment. At 5 years, BST-CarGel® treatment resulted in sustained and significantly superior repair tissue quantity and quality over microfracture alone. Clinical benefit following BST-CarGel® and microfracture treatment were highly significant over baseline levels.

01 Jun 2014·Osteoarthritis and CartilageQ2 · MEDICINE

Quantitative 3D MRI reveals limited intra-lesional bony overgrowth at 1 year after microfracture-based cartilage repair

Q2 · MEDICINE

Article

Author: Shive, M S ; Stanish, W D ; Tamez-Peña, J ; Steinwachs, M ; Restrepo, A ; Totterman, S ; Schreyer, E

OBJECTIVEIntra-lesional bony overgrowth (BO) identified during or following cartilage repair treatment is being frequently described through subjective reports focusing primarily on incidence. Our objective was to quantify the exact volume of intra-lesional BO at 12 months post-cartilage repair treatment, to determine if a correlation exists between the extent of BO and clinical outcomes, and to visualize and characterize the BO.DESIGNMRI scans were systematically obtained during a randomized clinical trial for cartilage repair (Stanish et al., 2013) that compared two microfracture-based treatments in 78 patients. Semi-automated morphological segmentation of pre-treatment, 1 and 12 months post-treatment scans utilizing a programmed anatomical atlas for all knee bone and cartilage structures permitted three-dimensional reconstruction, quantitative analysis, as well as qualitative characterization and artistic visualization of BO.RESULTSLimited intra-lesional BO representing only 5.8 ± 5.7% of the original debrided cartilage lesion volume was found in 78 patients with available MRIs at 12 months. The majority (80%) of patients had very little BO (<10%). Most occurrences of BO carried either spotty (56.4%) or planar (6.4%) morphological features, and the remaining balance (37.2%) was qualitatively unobservable by eye. Pre-existing BO recurred at 12 months in the same intra-lesional location in 36% of patients. No statistical correlations were found between BO and clinical outcomes.CONCLUSIONSIntra-lesional BO following microfracture-based treatments may not be as severe as previously believed, its incidence is partly explained by pre-existing conditions, and no relationship to clinical outcomes exists at 12 months. Morphologically, observable BO was categorized as comprising either spotty or planar bone.

100 Deals associated with Piramal Healthcare (Canada) Ltd.

100 Translational Medicine associated with Piramal Healthcare (Canada) Ltd.

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Piramal Healthcare (Canada) Ltd.

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