An Expanded Access Program of Garetosmab in Adult Patients With Fibrodysplasia Ossificans Progressiva (FOP)
NCT07301450 · Status: TEMPORARILY_NOT_AVAILABLE · Type: EXPANDED_ACCESS
Last updated 2025-12-24
Summary
The objective of this Expanded Access Program (EAP) is to provide garetosmab to patients with Fibrodysplasia Ossificans Progressiva (FOP) who have completed the double-blind treatment period of the parent study, OPTIMA (R2477-FOP-2175 \[NCT05394116\]), prior to marketing authorization approval, unless otherwise specified by country specific regulations for rare diseases.
Conditions
- Fibrodysplasia Ossificans Progressiva (FOP)
Interventions
- DRUG
-
Administration as described in the protocol
Sponsors & Collaborators
- lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
More Related Trials
-
Losartan to Improve Hip Microfracture
NCT04212650 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
A Study of REcycled CartiLage Auto/Allo IMplantation to Treat and Repair Focal Hip Cartilage Defects
NCT05553132 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Safety & Effectiveness of Autologous Regenerative Cell Therapy on Pain & Inflammation of Osteoarthritis of the Hip
NCT02844764 ·Status: RECRUITING ·Phase: PHASE2
-
Injections of FloGraft Therapy, Autologous Stem Cells, or Platelet Rich Plasma for the Treatment of Degenerative Joint Pain
NCT01978639 ·Status: UNKNOWN
-
Long-term Safety and Effectiveness of AUGMENT® Bone Graft Compared to Autologous Bone Graft
NCT02879149 ·Status: UNKNOWN
-
Prospective Functional Outcome Study of the Knee
NCT02079493 ·Status: TERMINATED
-
Osseous Setting Improvement With Co-implantation of Osseous Matrix and Mesenchymal Progenitors Cells From Autologous Bone Marrow
NCT00557635 ·Status: SUSPENDED ·Phase: PHASE2
-
Augment® Injectable Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Hindfoot Fusions
NCT01305356 ·Status: COMPLETED ·Phase: NA
-
Teriparatide for Improved Knee Prosthesis Fixation
NCT01063504 ·Status: COMPLETED ·Phase: PHASE2
-
Treatment of Osteoarthritis by Intra-articular Injection of Bone Marrow Mesenchymal Stem Cells With Platelet Rich Plasma
NCT02365142 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
Safety & Effectiveness of Autologous Regenerative Cell Therapy on Pain & Inflammation of Osteoarthritis of the Knee
NCT02844751 ·Status: RECRUITING ·Phase: PHASE2
-
Safety and Feasibility Study of Mesenchymal Trophic Factor (MTF) for Treatment of Osteoarthritis
NCT02003131 ·Status: WITHDRAWN ·Phase: PHASE1/PHASE2
-
Roentgen Stereophotogrammetric Analysis (RSA) to Evaluate Fixation of Biofoam Advance Total Knee Arthroplasty Components
NCT00657956 ·Status: COMPLETED ·Phase: NA
-
A Disease-based Treatment Study for Diagnosed Osteoarthritis Utilizing Adipose-derived Regenerative Cells
NCT04405297 ·Status: TERMINATED
-
Adipose-Derived Biocellular Regenerative Therapy for Osteoarthritis
NCT04238143 ·Status: RECRUITING ·Phase: NA
-
Comparison of BioCart™II With Microfracture for Treatment of Cartilage Defects of the Femoral Condyle
NCT00729716 ·Status: UNKNOWN ·Phase: PHASE2
-
Autologous Adipose-Derived Stromal Cells Delivered Intra-articularly in Patients With Osteoarthritis.
NCT01739504 ·Status: TERMINATED ·Phase: NA
-
Follow-up Study for Participants Jointstem Clinical Trial
NCT03509025 ·Status: COMPLETED ·Phase: PHASE2
-
Use of Cell Therapy to Enhance Arthroscopic Knee Cartilage Surgery
NCT01799876 ·Status: COMPLETED ·Phase: NA
-
Clinical and Biomolecular Assessment for the Monitoring of Patients Undergoing Regenerative Medicine Treatments with Orthobiologics
NCT04711551 ·Status: RECRUITING
-
Autologous Transplantation of Mesenchymal Stem Cells (MSCs) and Scaffold in Full-thickness Articular Cartilage
NCT00850187 ·Status: COMPLETED ·Phase: PHASE1
-
Stem Cell Study in Osteoarthritis of the Knee and Hip Joints
NCT05507099 ·Status: RECRUITING ·Phase: PHASE2
-
Use of Leukocyte-Rich PRP or Leukocyte-Free PRP in the Treatment of Hip Osteoarthritis
NCT05497349 ·Status: RECRUITING ·Phase: NA
-
Randomized Evaluation of BST-CarGel Versus Microfracture Alone On Recovery From Distal Femoral Cartilage Lesions
NCT02981355 ·Status: TERMINATED ·Phase: PHASE4
-
Follow-Up Study Evaluating The Long Term Safety and Efficacy of BST-CarGel and Microfracture Repair of the Knee
NCT01246895 ·Status: COMPLETED