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KUR-113 Bone Graft Versus Local Autograft for the Treatment of Single-level Transforaminal Lumbar Interbody Fusion

NCT04294004 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-08-09

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and efficacy of KUR-113 Bone Graft (TGplPTH1-34 in fibrin) compared to local autograft for the treatment of Degenerative Disk Disease (DDD).

Conditions

  • Degenerative Disc Disease
  • Spinal Fusion

Interventions

COMBINATION_PRODUCT

TGplPTH1-34 in fibrin

TGplPTH1-34 within a fibrin matrix applied within and around a polyetheretherketone (PEEK) intervertebral cage

OTHER

Autologous Bone Graft

Local autograft collected from decompression which may be supplemented with iliac crest bone graft (ICBG) if local autograft is insufficient.

Sponsors & Collaborators

  • Avania

    collaborator INDUSTRY

  • Kuros BioSciences B.V.

    collaborator INDUSTRY

  • Kuros Biosurgery AG

    lead INDUSTRY

Principal Investigators

  • John Chi, MD · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-27
Primary Completion
2024-07-30
Completion
2025-07-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04294004 on ClinicalTrials.gov