Osteoarthritis, Knee Clinical Trial
Official title:
Articular Cartilage Regeneration in Gonarthrosis Grade II and III by Articular Infiltration of Xcel-m-condro-alpha.
This is a prospective, open-label, single-dose, single-arm phase I-II study in which 15
patients diagnosed with gonarthrosis grade II-III (Kellgren and Lawrence) will enter the
study with the primary objective of assessing the feasibility and safety of the knee
articular infiltration of autologous bone marrow mesenchymal stem cells (MSC). Secondary
objectives are to assess the efficacy by imaging procedures and clinical questionnaires.
MSC obtained from each patient's bone marrow will be isolated and expanded "Ex-Vivo" under
GMP conditions at Xcelia-División de Terapias avanzadas del Banc de Sang I Teixits. After 21
days, patients will be implanted a single-dose of approximately 40 millions of autologous
MSC in the knee by articular injection, and followed up for 12 month. Articular cartilage
changes will be determined by T2-weighted MRI (Cartigram) at 6 and 12 month. Clinical
assessment will measure the pain by the visual analogue scale (VAS), the self-reported
functional status by Heath Assessment Questionnaire (HAQ), and the quality of life by Short
Form 36 questionnaire (SF-36) at 3, 6 and 12 month.
The working hypothesis proposes that the expected regenerative articular cartilage effect of
the MSC will be produced to a measurable degree by imaging procedures and clinical
questionnaires.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03895489 -
Effectiveness of the Journey Total Knee Arthroplasty Versus Two Standard of Care Total Knee Arthroplasty Prostheses
|
N/A | |
| Completed |
NCT03660943 -
A Clinical Study to Test Efficacy and Safety of Repeat Doses of CNTX-4975-05 in Patients With Osteoarthritis Knee Pain
|
Phase 3 | |
| Completed |
NCT04531969 -
Comparison of Outpatient and Inpatient Spa Therapy
|
N/A | |
| Completed |
NCT02848027 -
Correlating the Osteoarthritic Knee Microenvironment to Clinical Outcome After Treatment With Regenexx®SD Treatment
|
Phase 3 | |
| Completed |
NCT05160246 -
The Instant Effect of Kinesiology Taping in Patients With Knee OA
|
N/A | |
| Recruiting |
NCT06080763 -
Biomechanics and Clinical Outcomes in Responders and Non-Responders
|
||
| Completed |
NCT03643588 -
The Comparison of HYAJOINT Plus and Hyalgan Hyaluronan Supplement for Knee Osteoarthritis Pain
|
N/A | |
| Active, not recruiting |
NCT05100225 -
Efficacy and Safety Trial of PTP-001 (MOTYS) for Symptomatic Knee Osteoarthritis
|
Phase 2 | |
| Active, not recruiting |
NCT04061733 -
New Hydroxyethyl Cellulose Hydrogel for the Treatment of the Pain of Knee Arthrosis
|
N/A | |
| Completed |
NCT04051489 -
A Novel Smartphone Application for "Smart" Knee Osteoarthritis Trials
|
||
| Recruiting |
NCT05546541 -
Epidemiology and Nutrition
|
||
| Recruiting |
NCT05447767 -
Prediction AlgoriThm for regeneraTive Medicine Approach in knEe OA: New Decision-making Process Based on Patient pRofiliNg
|
Phase 2 | |
| Not yet recruiting |
NCT04448106 -
Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) for Osteoarthritis
|
Phase 2 | |
| Not yet recruiting |
NCT03225911 -
Effect of a Lateral Wedge Insole and Simple Knee Sleeve in Individuals With Knee Osteoarthritis
|
N/A | |
| Completed |
NCT05070871 -
A Clinical Trial Investigating the Effect of Salmon Bone Meal on Osteoarthritis Among Men and Women
|
N/A | |
| Completed |
NCT05703087 -
Positive Cueing in Knee Arthroplasty.
|
N/A | |
| Not yet recruiting |
NCT06042426 -
Effects of Perioperative Intravenous Dexamethasone in Clinical Outcomes After Total Knee Arthroplasty in a Hispanic Population
|
Phase 4 | |
| Terminated |
NCT02615522 -
Prospective Post Market Clinical Follow-Up of the Primary Knee Endoprosthesis BPK-S Integration
|
||
| Terminated |
NCT02909257 -
Motor-Sparing Femoral Nerve Block Dose
|
Phase 4 | |
| Completed |
NCT03037489 -
A Study to Evaluate Safety and Tolerability of MIV-711 in Osteoarthritis Patients
|
Phase 2 |