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8,270 results on '"A. Achrol"'

2. Mesenchymal Stromal Cell Implants for Chronic Motor Deficits After Traumatic Brain Injury: Post Hoc Analysis of a Randomized Trial.

Author

Okonkwo, David, McAllister, Peter, Achrol, Achal, Karasawa, Yasuaki, Kawabori, Masahito, Cramer, Steven, Lai, Albert, Kesari, Santosh, Frishberg, Benjamin, Groysman, Leonid, Kim, Anthony, Schwartz, Neil, Chen, Jefferson, Imai, Hideaki, Yasuhara, Takao, Chida, Dai, Nejadnik, Bijan, Bates, Damien, Stonehouse, Anthony, Richardson, R, Steinberg, Gary, Poggio, Eugene, and Weintraub, Alan

Subjects
Humans, Brain Injuries, Traumatic, Male, Adult, Female, Double-Blind Method, Mesenchymal Stem Cell Transplantation, Middle Aged, Prospective Studies, Treatment Outcome, Young Adult
Abstract

BACKGROUND AND OBJECTIVES: Traumatic brain injury (TBI) is frequently characterized by chronic motor deficits. Therefore, this clinical trial assessed whether intracranial implantation of allogeneic modified mesenchymal stromal (SB623) cells can improve chronic motor deficits after TBI. METHODS: Post hoc analysis of the double-blind, randomized, prospective, surgical sham-controlled, phase 2, STEMTRA clinical trial (June 2016 and March 2019) with 48 weeks of follow-up was conducted. In this international, multicenter clinical trial, eligible participants had moderate-to-severe TBI, were ≥12 months postinjury, and had chronic motor deficits. Participants were randomized in a 1:1:1:1 ratio to stereotactic surgical intracranial implantation of SB623 cells (2.5 × 106, 5.0 × 106, 10 × 106) or surgical sham-controlled procedure. The prespecified primary efficacy end point was significantly greater change from baseline of the Fugl-Meyer Motor Scale (FMMS) score, a measure of motor status, for the SB623 pooled vs control arm at 24 weeks. RESULTS: A total of 211 participants were screened, 148 were excluded, and 63 underwent randomization, of which 61 (97%; mean age, 34 [SD, 12] years; 43 men [70.5%]) completed the trial. Single participants in the SB623 2.5 × 106 and 5.0 × 106 cell dose groups discontinued before surgery. Safety and efficacy (modified intent-to-treat) were assessed in participants who underwent surgery (N = 61; SB623 = 46, controls = 15). The primary efficacy end point (FMMS) was achieved (least squares mean [SE] SB623: +8.3 [1.4]; 95% CI 5.5-11.2 vs control: +2.3 [2.5]; 95% CI -2.7 to 7.3; p = 0.04), with faster improvement of the FMMS score in SB623-treated groups than in controls at 24 weeks and sustained improvement at 48 weeks. At 48 weeks, improvement of function and activities of daily living (ADL) was greater, but not significantly different in SB623-treated groups vs controls. The incidence of adverse events was equivalent in SB623-treated groups and controls. There were no deaths or withdrawals due to adverse events. DISCUSSION: Intraparenchymal implantation of SB623 cells was safe and significantly improved motor status at 24 weeks in participants with chronic motor deficits after TBI, with continued improvement of function and ADL at 48 weeks. Cell therapy can modify chronic neurologic deficits after TBI. TRIAL REGISTRATION INFORMATION: ClinicalTrials.gov Identifier: NCT02416492. Submitted to registry: April 15, 2015. First participant enrolled: July 6, 2016. Available at: classic.clinicaltrials.gov/ct2/show/NCT02416492. CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that intracranial implantation of allogeneic stem (SB623) cells in adults with motor deficits from chronic TBI improves motor function at 24 weeks.

Published
2024

4. Msp Handling And Transportation Work Of Kvss Achrol Dist

Subjects
Transportation, Transportation industry, Business, international
Abstract

Tenders are invited for MSP Handling and Transportation Work of KVSS Achrol Dist. Doc Fees: INR 5900.00 Tender Category: Works Earnest Money: INR 3200.00 OpeningDate: Mar 4 2024 12:00AM EMD [...]

Published
2024

5. Handling And Transportation Work Of Dalhan/tilhan 2023-24 At Kvss Achrol

Subjects
Transportation, Transportation industry, Business, international
Abstract

Tenders are invited for Handling and Transportation Work of Dalhan/tilhan 2023-24 at Kvss Achrol. Tender Category: Services OpeningDate: Mar 4 2024 12:00AM Major organization: Rajasthan State Cooperative Marketing Federation Limited [...]

Published
2024

7. Drain Cleaning And Garbage Collection Work Gram Achrol

Subjects
Refuse collection, Business, international
Abstract

Tenders are invited for Drain cleaning and garbage collection work Gram Achrol Doc Fees: INR 500.00 Tender Category: Services Earnest Money: INR 10000.00 OpeningDate: Feb 22 2024 12:00AM EMD value: [...]

Published
2024

14. Samudayik Bhawan Construction Work Bolyawala Gp Achrol

Subjects
Business, international
Abstract

Tenders are invited for Samudayik Bhawan Construction Work Bolyawala Gp Achrol Doc Fees : INR 500.00 Tender Category : Works Earnest Money : INR 20000.00 OpeningDate : Oct 3 2023 [...]

Published
2023

15. Construction Of General Library Raiger Basti Achrol

Subjects
Business, international
Abstract

Tenders are invited for Construction of General Library Raiger Basti Achrol. Doc Fees : INR 500.00 Tender Category : Works Earnest Money : INR 20000.00 OpeningDate : Oct 3 2023 [...]

Published
2023

24. Construction of CHC Building at Achrol, Distt. -I. Sr- 1

Subjects
Business, international
Abstract

Tenders are invited for Construction of CHC Building at Achrol, Distt. -I. Sr- 1 Doc Fees : INR 5000.00 Tender Category : Works Earnest Money : INR 906000.00 OpeningDate : [...]

Published
2023

28. Work Of Approach Road Achrol

Subjects
Business, international
Abstract

Tenders are invited for Work of approach road achrol Doc Fees : INR 500.00 Tender Category : Works Earnest Money : INR 34540.00 OpeningDate : Jun 16 2023 12:00AM EMD [...]

Published
2023

29. Approach Road Achrol

Subjects
Business, international
Abstract

Tenders are invited for Approach road achrol. Tender Category : Works OpeningDate : Jun 16 2023 12:00AM Major organization : Public Works Department Address : Pwd Division Shahpura Jaipur, Pwd [...]

Published
2023

41. Work Of The Cleaning Of Reservoir By Mechanized Means Including Dewatering, Removal Of All Silt, Scrapping Of Wall High Pressure Cleaning Followed By Vaccum Cleaning And Disinfection Of Reservoir In Section Achrol Sub Division Amer. Works And Water

Subjects
Infection control, Soils, Silt, Reservoirs, Business, international
Abstract

Tenders are invited for Work of the cleaning of reservoir by mechanized means including dewatering, removal of all silt, scrapping of wall high pressure cleaning followed by vaccum cleaning and [...]

Published
2023

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