A Phase 3, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy, Safety, and Tolerability of Chondroitin Sulfate 800 mg Tablets Versus Placebo in Subjects With Pain Due to Knee Osteoarthritis and to Evaluate the Durability of the Effect and Safety of the Treatment

The goal of this phase III study is to evaluate the efficacy, safety, and tolerability of chondroitin sulfate 800 mg oral tablets versus placebo in the treatment of subjects with pain due to knee OA (osteoarthritis). The further aims of the study are to evaluate the durability of the treatment effect (up to week 36) and to gain further long-term safety and efficacy data (up to 48 weeks).
The primary outcome of interest will be the effect of chondroitin sulfate on pain in the index knee at week 24 compared to placebo.
The effect of chondroitin sulfate in the index knee functionality and the patient global impression of changes at 24 weeks compared to placebo are included as key-secondary endpoints. An additional key secondary endpoint will assess the durability of the effect on pain compared to placebo at week 36. Several additional secondary endpoints are included to further support the beneficial effect of the treatment and the improvements in patient's quality of life (i.e., Western Ontario and McMaster Universities Arthritis Index -WOMAC- subscales and total scores at each study visits, changes in patient's quality of life, use of rescue medication etc.) other than the safety of the product.

Start Date01 Dec 2023

Sponsor / Collaborator

IBSA Institut Biochimique SA

EUCTR2008-000871-19-FR / Not yet recruitingPhase 4

Comparative study of efficacy and safety of Structum® and Chondrosulf® in patients with symptomatic osteoarthritis of the knee.A Multicenter, Randomized, Double-Blind, Double Placebo-Controlled, Parallel Group Study

Start Date10 Apr 2008

Sponsor / Collaborator

Pierre Fabre Médicament SAS

NCT00604539 / CompletedPhase 3

Study of the Effect of Chondroitin Sulphate on Synovial Inflammation in Patients With Osteoarthritis of the Knee

The purpose of this study is to determine the effect of a chondroitin sulphate conventional treatment on the degree of severity of synovitis, as measured by magnetic resonance in patients with knee OA with clinical synovitis.

Start Date01 Feb 2008

Sponsor / Collaborator

Bioibérica SA

100 Clinical Results associated with Chondroitin Sulfate Sodium

100 Translational Medicine associated with Chondroitin Sulfate Sodium

100 Patents (Medical) associated with Chondroitin Sulfate Sodium

447

Literatures (Medical) associated with Chondroitin Sulfate Sodium

01 Nov 2024·JOURNAL OF CONTROLLED RELEASE

Laser-responsive erastin-loaded chondroitin sulfate nanomedicine targeting CD44 and system xc− in liver cancer: A non-ferroptotic approach

Article

Author: Koo, Jang Mo ; Kim, Hyun Young ; Park, Jong Chan ; Jeon, Jang Su ; Kim, Sang Kyum ; Koh, Seokjin ; Oh, Soo Jin ; Lee, Sang Min ; Baek, Min-Jun ; Yoo, Ji Hoon ; Lee, Ji-Yoon ; Lee, Dong Hwan ; Kim, Dong Hyun ; Yu, Jieun ; Lee, Jae-Young ; Kang, Keon Wook ; Yoo, So-Yeol ; Kim, Dae-Duk ; Shim, Wan Seob

Erastin, a ferroptosis-inducing system x_c^- inhibitor, faces clinical challenges due to suboptimal physicochemical and pharmacokinetic properties, as well as relatively low potency and off-target toxicity. Addressing these, we developed ECINs, a novel laser-responsive erastin-loaded nanomedicine utilizing indocyanine green (ICG)-grafted chondroitin sulfate A (CSA) derivatives. Our aim was to improve erastin's tumor targeting via CSA-CD44 interactions and enhance its antitumor efficacy through ICG's photothermal and photodynamic effects in the laser-on state while minimizing off-target effects in the laser-off state. ECINs, with their nanoscale size of 186.7 ± 1.1 nm and high erastin encapsulation efficiency of 93.0 ± 0.8%, showed excellent colloidal stability and sustained drug release up to 120 h. In vitro, ECINs demonstrated a mechanism of cancer cell inhibition via G1-phase cell cycle arrest, indicating a non-ferroptotic action. In vivo biodistribution studies in SK-HEP-1 xenograft mice revealed that ECINs significantly enhanced tumor distribution of erastin (1.9-fold greater than free erastin) while substantially reducing off-target accumulation in the lungs and spleen by 203-fold and 19.1-fold, respectively. Combined with laser irradiation, ECINs significantly decreased tumor size (2.6-fold, compared to free erastin; 2.4-fold, compared to ECINs without laser irradiation) with minimal systemic toxicity. This study highlights ECINs as a dual-modality approach for liver cancer treatment, demonstrating significant efficacy against tumors overexpressing CD44 and system x_c^-.

01 Sep 2024·CHEMISTRY AND PHYSICS OF LIPIDS

Interaction of chondroitin sulfate with zwitterionic lipid membranes

Article

Author: Żak, Agata ; Kepczynski, Mariusz ; Łazarski, Grzegorz ; Rajtar, Natan ; Jamróz, Dorota

Chondroitin sulfates (CSs) are important components of the extracellular matrix and side chains of membrane proteoglycans. These polysaccharides are, therefore, likely to interact with plasma membranes and play a significant role in modulating cellular functions. So far, the details of the processes occurring at the interface between the extracellular matrix and cellular membranes are not fully understood. In this study, we used experimental methods and atomic-scale molecular dynamics (MD) simulations to reveal the molecular picture of the interactions between CS and phosphocholine (PC) membranes, used as a simplified model of cell membranes. MD simulations reveal that the polysaccharide associates to the PC bilayer as a result of electrostatic interactions between the positively charged quaternary ammonium groups of choline and the negatively charged sulfate groups of CS. Compared to an aqueous medium, the adsorbed polysaccharide chains adopt more elongated conformations, which facilitates the electrostatic interactions with the membrane, and have a high degree of freedom to change their conformations and to adhere to and detach from the membrane surface. Penetrating slightly between the polar groups of the bilayer, they form a loosely anchored layer, but do not intrude into the hydrophobic region of the PC bilayer. The CS adsorption spread the PC headgroups apart, which is manifested by an increase in the value of the area pre lipid. The expansion of the lipid polar groups weakens the dispersion interactions between the lipid acyl chains. As a result, the lipid membrane in the membrane-polysaccharide contact areas becomes more fluid. Our outcomes may help to understand in detail the interaction of chondroitin sulfate with zwitterionic membranes at the molecular level, which is of biological interest since many biological processes depend on lipid-CS interactions.

19 Aug 2024·ACS Applied Bio Materials

Chondroitin Sulfate and Hyaluronic Acid–Based PolyHIPE Scaffolds for Improved Osteogenesis and Chondrogenesis In Vitro

Article

Author: Vaidya, Anuradha ; Ingavle, Ganesh ; Behere, Isha

Osteochondral damage, affecting the articular cartilage and the underlying subchondral bone, presents significant challenges in clinical treatment. Such defects, commonly seen in knee and ankle joints, vary from small localized lesions to larger defects. Current medical therapies encounter several challenges, such as donor shortages, drug side effects, high costs, and rejection problems, often resulting in only temporary relief. Highly porous emulsion-templated polymers (polyHIPEs) offer numerous potential benefits in the fabrication of scaffolds for tissue engineering and regenerative medicine. Polymeric scaffolds synthesized using a high internal phase emulsion (HIPE) technique, called PolyHIPEs, involve polymerizing a continuous phase surrounding a dispersed internal phase to form a solid, foam-like structure. A dense, porous design encourages cell ingrowth, nutrient delivery, and waste disposal from the scaffold, mimicking the cells' natural microenvironment. This study used hydroxyethyl methacrylate (HEMA) and acrylamide (AAM) polyHIPE scaffolds combined with extracellular matrix (ECM) components of the tissue, such as methacrylated hyaluronic acid (MHA) and methacrylated chondroitin sulfate (MCS), to prepare polyHIPE scaffolds. The mouse preosteoblast MC3T3-E1 cells and primary rat chondrocytes (harvested from male Wistar rats) were seeded on the scaffolds and cultured for 21 days to assess the osteogenesis and chondrogenesis in vitro. When compared to the AAM-MHA and AAM-MCS groups at day 21, scaffold groups HEMA-MHA and HEMA-MCS showed a significant rise in alkaline phosphatase (ALP) and calcium content. Chondrogenic markers such as glycosaminoglycan (GAG) and hydroxyproline were also assessed over a 21-day time point. On day 21, it was found that GAG and hydroxyproline production were considerably higher in the HEMA-MHA and HEMA-MCS scaffolds than in the AAM-MHA and AAM-MCS scaffolds. The overall studies showed that polyHIPE monolith scaffolds could favor cell adherence, survival ability, proliferation, differentiation, and ECM formation over 21 days. Thus, incorporating ECM components enhanced osteogenesis and chondrogenesis in vitro and can be further used as tissue repair models.

News (Medical) associated with Chondroitin Sulfate Sodium

05 Aug 2009

·www.biospace.com

Stellar Pharmaceuticals Inc. Announces Record Second Quarter Revenues and Profitability for the First Half

LONDON, ONTARIO--(Marketwire - August 05, 2009) - Stellar Pharmaceuticals Inc. ("Stellar" or the "Company")(OTCBB: SLXCF) a Canadian pharmaceutical developer and marketer of high quality, cost effective products for select health care markets, today announced that its second quarter revenues increased by 65.8% to $1,074,300 compared to $647,900 for the same period last year and that the Company had a profit of $164,700 for the quarter compared to a loss of $68,000 in the second quarter of 2008. This is the third consecutive quarter that the Company has shown a profit. For the six month period ended June 30, 2009 Stellar's total revenues increased by 57.1% to $1,846,800 compared to $1,175,300 for the same period in 2008. Canadian sales for NeoVisc and Uracyst were up by 22.2% and 21.9% respectively for the period. International sales increased by 121.4% for this period as the Company's European partners continue to gain traction with both NeoVisc and Uracyst sales. The Company showed a profit of $189,900 for the first half of 2009 compared to a loss of $166,800 over the same period in 2008. Peter Riehl, Stellar's President and CEO, stated, "This is the strongest second quarter in the Company's history, with revenues up in all markets. We are very pleased to show profitability for the quarter and on a year-to-date basis, this currently puts the Company in a good position for strong operating results for the end of 2009. Besides these encouraging results, it has also been a very active quarter in other areas; Watson Pharmaceuticals received an IDE from the FDA and has now started a pilot clinical trial at a number of centers in the USA, the Company also launched its NeoVisc Single Dose (one injection) in mid June and we are very pleased with initial sales generated. In addition, the Company continues to actively search for new partners to out-license its products to around the world. It is very rewarding to see this growth and escalating business development activities, given the challenging economic times." About Stellar Pharmaceuticals Inc. Stellar has developed and is marketing direct in Canada and in countries around the world through out-license agreements two products based on its core polysaccharide technology: NeoVisc®, for the treatment of osteoarthritis; and Uracyst®, its patented technology for treatment of interstitial cystitis/painful bladder syndrome an inflammatory disease of the urinary bladder wall. Stellar also has in-licensing agreement for the distribution and sale of NMP22® BladderChek®, a proteomics-based diagnostic test for the diagnosis and monitoring of bladder cancer. This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995. Readers are cautioned not to place undue reliance on these forward-looking statements. Actual results may differ materially from those indicated by these forward-looking statements as a result of risks and uncertainties impacting the Company's business including increased competition; the ability of the Company to expand its operations, to attract and retain qualified professionals, technological obsolescence; general economic conditions; and other risks detailed from time to time in the Company's filings. STELLAR PHARMACEUTICALS INC. CONDENSED BALANCE SHEETS (Expressed in Canadian Dollars) As at As at June 30, 2009 December 31, 2008 --------------- ----------------- (Unaudited) (Audited) ASSETS CURRENT Cash and cash equivalents $ 1,882,040 $ 2,105,966 Accounts receivable, net of allowance $nil (2008 - $nil) 676,827 549,055 Inventories 651,296 364,551 Taxes recoverable 205,885 212,445 Loan receivable 18,369 18,369 Prepaids, deposits and sundry receivables 276,634 130,515 --------------- ----------------- 3,711,051 3,380,901 PROPERTY, PLANT AND EQUIPMENT 1,248,699 1,270,257 OTHER ASSETS 91,048 65,495 --------------- ----------------- $ 5,050,798 $ 4,716,653 --------------- ----------------- --------------- ----------------- LIABILITIES CURRENT Accounts payable $ 183,684 $ 173,812 Accrued liabilities 339,794 186,201 Deferred revenues 3,850 1,749 --------------- ----------------- 527,328 361,762 --------------- ----------------- CONTINGENCIES AND COMMITMENTS SHAREHOLDERS' EQUITY CAPITAL STOCK AUTHORIZED Unlimited Non-voting, convertible, redeemable, and retractable preferred shares with no par value Unlimited Common shares with no par value ISSUED 23,495,040 Common shares (2008 - 23,702,540) 8,188,486 8,261,403 Nil - Treasury shares (2008 - (147,500)) - (51,625) Additional paid-in capital for cancelled common shares 2,329 2,329 Additional paid-in capital options - outstanding 35,965 35,965 - expired 722,372 722,372 --------------- ----------------- 8,949,152 8,970,444 DEFICIT (4,425,682) (4,615,553) --------------- ----------------- 4,523,470 4,354,891 --------------- ----------------- $ 5,050,798 $ 4,716,653 --------------- ----------------- --------------- ----------------- STELLAR PHARMACEUTICALS INC. CONDENSED INTERIM STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS AND DEFICIT (Expressed in Canadian Dollars) (Unaudited) For the Three Month Period For the Six Month Period Ended June 30 Ended June 30 2009 2008 2009 2008 ------------ ------------ ------------ ------------- PRODUCT SALES $ 914,126 $ 645,535 $ 1,458,545 $ 974,991 COST OF PRODUCTS SOLD 333,082 148,937 488,034 260,332 ------------ ------------ ------------ ------------ MARGIN ON PRODUCTS SOLD 581,044 496,598 970,511 714,659 ROYALTY AND LICENSING REVENUES 160,168 2,400 388,265 200,356 ------------ ------------ ------------ ------------ GROSS PROFIT 741,212 498,998 1,358,776 915,015 ------------ ------------ ------------ ------------ EXPENSES Selling, general and administrative 562,941 551,893 1,140,996 1,042,885 Research and development 1,803 4,424 7,411 58,242 Amortization (non-manufacturing property, plant and equipment) 13,703 30,044 27,401 60,426 ------------ ------------ ------------ ------------ 578,447 586,361 1,175,808 1,130,269 ------------ ------------ ------------ ------------ INCOME (LOSS) FROM OPERATIONS 162,765 (87,363) 182,968 (215,254) INTEREST AND OTHER INCOME 1,929 19,349 6,903 48,423 ------------ ------------ ------------ ------------ NET INCOME (LOSS) AND COMPREHENSIVE INCOME (LOSS) FOR THE PERIOD 164,694 (68,014) 189,871 (166,831) DEFICIT, beginning of period (4,590,376) (4,675,438) (4,615,553) (4,576,621) Effect of repurchase and cancellation of Common Shares - (2,933) - (2,933) DEFICIT, end of period $(4,425,682) $ (4,746,385) $ (4,425,682) $ (4,746,385) ------------ ------------ ------------ ------------ ------------ ------------ ------------ ------------ EARNINGS (LOSS) PER SHARE $ 0.01 $ (0.00) $ 0.01 $ (0.01) ------------ ------------ ------------ ------------ ------------ ------------ ------------ ------------ WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING 23,495,040 23,755,759 23,816,387 23,788,919 ------------ ------------ ------------ ------------ ------------ ------------ ------------ ------------ STELLAR PHARMACEUTICALS INC. CONDENSED INTERIM STATEMENTS OF CASH FLOWS (Expressed in Canadian Dollars) (Unaudited) For the Three Month Period For the Six Month Period Ended June 30 Ended June 30 2009 2008 2009 2008 ------------ ------------ ------------- ------------ CASH FLOWS USED IN OPERATING ACTIVITIES - Net income (loss) for the period $ 164,694 $ (68,014) $ 189,871 $ (166,831) Items not affecting cash Amortization 33,117 30,044 68,112 60,426 Unrealized foreign exchange (gain) loss 19,128 (7,912) 20,523 2,317 Issuance of equity instruments for services rendered - 7,538 - 13,125 Change in non-cash operating asset and liabilities (593,295) 2,788 (390,251) (109,397) ------------ ------------ ------------- ------------ CASH FLOWS USED IN OPERATING ACTIVITIES (376,356) (35,556) (111,745) (200,360) ------------ ------------ ------------- ------------ CASH FLOWS USED IN INVESTING ACTIVITIES - Additions to property, plant and equipment (43,938) (177,971) (44,135) (193,877) Increase to other assets (19,274) - (26,231) (6,063) ------------ ------------ ------------- ------------ CASH FLOWS USED IN INVESTING ACTIVITIES (63,212) (177,971) (70,366) (199,940) ------------ ------------ ------------- ------------ CASH FLOWS USED IN FINANCING ACTIVITIES - Repurchase of common shares for cash - (43,655) (21,292) (43,655) ------------ ------------ ------------- ------------ CASH FLOWS USED IN FINANCING ACTIVITIES - (43,655) (21,292) (43,655) ------------ ------------ ------------- ------------ EFFECT OF EXCHANGE RATES ON CASH HELD IN FOREIGN CURRENCY (19,127) 7,910 (20,523) (2,315) ------------ ------------ ------------- ------------ CHANGE IN CASH AND CASH EQUIVALENTS (458,695) (249,272) (223,926) (446,270) CASH AND CASH EQUIVALENTS, Beginning of period 2,340,735 3,014,128 2,105,966 3,211,126 ------------ ------------ ------------- ------------ CASH AND CASH EQUIVALENTS, End of period $ 1,882,040 $ 2,764,856 $ 1,882,040 $ 2,764,856 ------------ ------------ ------------- ------------ ------------ ------------ ------------- ------------ Contacts: Stellar Pharmaceuticals Inc. Peter Riehl President & CEO (800) 639-0643 or (519) 434-1540 Corpinfo@StellarPharma.com Stellar Pharmaceuticals Inc. Arnold Tenney (416) 587-3200

100 Deals associated with Chondroitin Sulfate Sodium

External Link

KEGG	Wiki	ATC	Drug Bank
D04078	Chondroitin Sulfate Sodium	M01AX25	DB09301

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Ophthalmologic surgical procedures	JP	Alcon Japan Ltd.	20 Aug 2009
Corneal Ulcer	CN	Jiangsu Puhua Kesheng Pharmaceutical Co Ltd	01 Jan 1982
Keratitis	CN	Jiangsu Puhua Kesheng Pharmaceutical Co Ltd	01 Jan 1982
Hyperlipidemias	CN	Tianjin Junan Biopharmaceutical Co Ltd.	01 Jan 1981
Corneal Injuries	JP	Santen Pharmaceutical Co., Ltd.	31 Mar 1970
Arthralgia	JP	Nippon Shinyaku Co., Ltd.	01 Nov 1963
Back Pain	JP	Nippon Shinyaku Co., Ltd.	01 Nov 1963
Hearing Loss, Sensorineural	JP	Nippon Shinyaku Co., Ltd.	01 Nov 1963
Neuralgia	JP	Nippon Shinyaku Co., Ltd.	01 Nov 1963
Periarthritis	JP	Nippon Shinyaku Co., Ltd.	01 Nov 1963

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Muscular Diseases	Phase 3	CA	Bioibérica SA	01 Feb 2008
Musculoskeletal Pain	Phase 3	CA	BIOIBERICA GmbH	01 Feb 2008
Osteoarthritis, Knee	Phase 3	CA	Bioibérica SA	01 Feb 2008
Synovitis	Phase 3	CA	Bioibérica SA	01 Feb 2008
Synovitis	Phase 3	CA	BIOIBERICA GmbH	01 Feb 2008

Clinical Result

Indication

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


P080 (ECCO2014)	Not Applicable	Inflammatory Bowel Diseases C-reactive protein \| orosomucoid \| erythrocyte sedimentation rate ... View more	37	Chondroitin sulphate	nkzhsawrcd(wotjehmxpp) = 43% of patients suffered adverse events, but only 5% were related to the drug obacklpsbw (lqvzqgbpqi ) View more	Positive	01 Feb 2014
P080 (ECCO2014)	Not Applicable		37	Placebo		Positive	01 Feb 2014
P081 (ECCO2013)	Not Applicable	Inflammatory Bowel Diseases VEGFA \| VEGFC \| FGF2 ... View more	29	Condroitin sulphate (CS)	hcbictpqgj(bywrmyfhti) = 30% of patients suffered adverse events, but only 6% were related to the drug bbygbnhxne (znvmsccydb )	Positive	01 Feb 2013

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Chondroitin Sulfate Sodium

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