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NCT03477942 · ClinicalTrials.gov registry record · Phase 1
Impact of Mesenchymal Stem Cells in Knee Osteoarthritis
A Phase 1 study of Knee Osteoarthritis and Musculoskeletal Pain, sponsored by University Hospitals Cleveland Medical Center.
- Active
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT03477942 is a Phase 1 study of Knee Osteoarthritis and Musculoskeletal Pain that is active but no longer recruiting, run by University Hospitals Cleveland Medical Center. The registered enrollment target is 16 participants, below the 304-participant average among 101 other Knee Osteoarthritis trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03477942, a Phase 1 study of Knee Osteoarthritis and Musculoskeletal Pain, is active but no longer recruiting, sponsored by University Hospitals Cleveland Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
Many patients with osteoarthritis of the knee fail non-operative measures and elect to have knee arthroplasty to improve their quality of life. If successful, intra-articular mesenchymal stem cell (MSC) injections into the knee may offer another viable non-operative treatment modality. Additionally, this modality may have reparative or regenerative potential, which could lead to the first treatment for osteoarthritis that treats the underlying disease as opposed to symptomatic control. Additionally, there are no acceptable non-surgical treatments for focal chondral defects of the knee. Surgical treatments that do exist have diminished outcomes if performed on patients older than age 30-40 years. If successful, intra-articular MSC injections into the knee would represent the first non-operative treatment for focal chondral defects and also represent a potential option for treatment in patients over the age of 30-40 years. This trial will be a prospective, single-center phase I pilot study to evaluate the safety and tolerability of a single intra-articular injection of autologous bone marrow-derived MSCs in 16 subjects, 8 who have knee osteoarthritis and 8 who have a focal chondral defect in the knee. Patients will undergo a bone marrow harvest procedure at the Dahms Clinical Research Unit (DCRU) of University Hospitals Cleveland Medical Center. MSCs will be isolated and expanded. After approximately 2-3 weeks, patients will return for an intra-articular injection of 50x106 MSCs Subsequent study visits will occur on post-injection day 7 and months 2, 6, 12, and 24. Safety of intra-articular injection of MSCs will be evaluated at study visits by interval history, physical examination and assessment of any adverse events that are observed/reported. Additionally, efficacy will be evaluated by having patients complete functional outcome measures including: Visual Analog Score (VAS) for pain, Knee Injury and Osteoarthritis Outcome Score (KOOS), International Knee Documen
Conditions Studied
Interventions
- BIOLOGICAL Autologous Mesenchymal Stem Cells
Study Locations (1)
Ohio
- University Hospital Cleveland Medical Center - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2018-10-01 |
| Est. Completion | 2026-07 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03477942
The ClinicalTrials.gov registry entry for NCT03477942 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 304-participant average among 101 other Knee Osteoarthritis trials with a reported enrollment target (95% lower). The listed sponsor is University Hospitals Cleveland Medical Center, which has 230 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Knee Osteoarthritis appearing as the primary indexed condition, and to 1 intervention - of which Autologous Mesenchymal Stem Cells is the first listed.
NCT03477942 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT03477942 about?
NCT03477942 is a clinical study titled "Impact of Mesenchymal Stem Cells in Knee Osteoarthritis". Many patients with osteoarthritis of the knee fail non-operative measures and elect to have knee arthroplasty to improve their quality of life. If successful, intra-articular mesenchymal stem cell (MSC) injections into the knee may offer another viable non-operative treatment modality. Additionally,...
What is the current status of trial NCT03477942?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2018-10-01. Estimated completion is 2026-07.
What conditions does trial NCT03477942 study?
This clinical trial studies the following conditions: Knee Osteoarthritis, Musculoskeletal Pain, Cartilage Injury, Cartilage Degeneration.
What interventions are being tested in trial NCT03477942?
The interventions under investigation include: Autologous Mesenchymal Stem Cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT03477942?
This trial is sponsored by University Hospitals Cleveland Medical Center, which has 230 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03477942 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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