A Phase 3 Prospective, Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy of Amniotic Suspension Allograft (ASA) in Patients With Osteoarthritis of the Knee

This study is being conducted to evaluate the efficacy and safety of ASA compared to placebo in the management of osteoarthritis (OA) symptoms of the knee.

Start Date06 Sep 2023

Sponsor / Collaborator

Organogenesis, Inc.

NCT04636229 / Active, not recruitingPhase 3

A Phase 3 Prospective, Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy of Amniotic Suspension Allograft (ASA) in Patients With Osteoarthritis of the Knee

This study is being conducted to evaluate the efficacy and safety of ASA compared to placebo in the management of osteoarthritis (OA) symptoms of the knee.

Start Date14 Dec 2020

Sponsor / Collaborator

Organogenesis, Inc.

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100 Clinical Results associated with Amniotic Suspension Allograft(Organogenesis)

100 Translational Medicine associated with Amniotic Suspension Allograft(Organogenesis)

100 Patents (Medical) associated with Amniotic Suspension Allograft(Organogenesis)

Literatures (Medical) associated with Amniotic Suspension Allograft(Organogenesis)

01 Jan 2024·EJVES Vascular Forum

The Impact of Heli-FX EndoAnchor Application on Endograft Material: An Experimental Study

Article

Author: Vakhitov, Damir ; Chakfé, Nabil ; Chaudhuri, Arindam ; Heim, Frédéric

ObjectiveThe physical impact of the application of Heli-FX EndoAnchors (EA; Medtronic, Minneapolis, USA) on endograft (EG) material is unclear. This study aimed to examine the possible EG membrane alterations after EA implantation.MethodsHeli-FX EndoAnchors were applied in vitro into four aortic endocuffs: AFX2 (Endologix Inc., Irvine, USA); Endurant II (Medtronic, Minneapolis, USA); Gore Excluder (W.L. Gore and Assoc., Flagstaff, USA); and Zenith Renu (Cook Aortic Interventions, Bloomington, USA). Two of these, Endurant II and Renu, are made of polyethylene terephthalate (PET), while Excluder and AFX2 are made of expanded polytetrafluoroethylene (ePTFE). The penetration angle was measured for each EA. The EAs were then carefully removed, and perforations examined with digital and fluorescent microscopy. The area and perimeter of the holes were digitally calculated, and material alterations were analysed.ResultsOf the 13 EAs applied, 12 remained in place. The mean penetration angle was 79°. The ePTFE perforations had oval openings, while PET perforations were round. After EA removal, comparisons between ePTFE and PET material perforations suggested a larger hole area (p = 0.011) and perimeter (p = 0.003) in the former. The ePTFE perforations in the AFX2 were the largest compared with the holes in other endocuffs (p = 0.050). The perforation channel of the ePTFE membrane of the Excluder cuff retained its form after EA removal. Local dissection like layer damage extended further. The perforations in both the Endurant II and the Renu endocuffs shared similar characteristics, with multiple fibres of PET elongated, distorted, or ruptured.ConclusionDuring EA placement, the EG membrane undergoes local alteration and or destruction. Expanded PTFE, particularly AFX2 endocuffs (for which EA use is not recommended), are characterised by a more extensive degree of material alteration compared with PET. Additional studies are required to chronologically supplement these findings in fatigue tests.

100 Deals associated with Amniotic Suspension Allograft(Organogenesis)

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Indication	Highest Phase	Country/Location	Organization	Date
Osteoarthritis, Knee	Phase 3	-	Organogenesis, Inc.	21 Aug 2023

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


Corporate Publications Manual	Phase 3	Osteoarthritis, Knee	515	Amniotic Suspension Allograft(Organogenesis)	(kskbsmtmus): P-Value = 0.0177 View more	Positive	02 May 2024
				Placebo

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