A Phase 2 interventional study of "Ready to inject" Umbilical cord-derived Mesenchymal Stromal Cell (MSC) product and Resuspended Umbilical cord-derived Mesenchymal Stromal Cell (MSC) product in Osteo Arthritis Knee, sponsored by Universidad de los Andes, Chile. Status unknown. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-03-02.
Sponsored by Universidad de los Andes, Chile · Phase 2, Interventional, and Treatment
The goal of this clinical trial is to compare a newly developed off-the-shelf cryopreserved "ready to inject" Mesenchymal Stem Cell (MSC) product with the usual MSC preparation the investigators have used in knee osteoarthritis (OA) patients. Since usual MSC therapy requires cell manipulation in GMP (Good Manufacturing Practices)-type facilities, this new formulation would enable wider access to Cell therapy and Multicentric clinical trials in areas devoid of expensive facilities and equipment.
This is a double blind randomized controlled trial testing a modified formulation of an allogenic Umbilical cord (UC) derived MSC therapy that the investigators have used in a prior published clinical trial. It has been modified and characterized according to the standards of quality control that are required for the development an off-the-shelf cryopreserved MSCs product.
This so called "ready to inject" MSC preparation will be compared with the usual MSC formulation that requires centrifugation and resuspension in different media, thus requiring access to advanced (GMP-type) facilities.
A total of 60 symptomatic knee OA patients will be randomized (1.1 ratio) to receive one or the other MSC product at baseline and month 6, to be followed blindly for 12 months with baseline and end of study knee MRI imaging.
The primary endpoint of the trial will be the safety according to the occurrence of adverse events (AEs) as coded by the Common Terminology Criteria for Adverse Event classification. The secondary endpoint will be efficacy, as assessed by the following validated clinical outcome measures: Western Ontario and Mc Master Universities Arthritis Index (WOMAC) Spanish validated version, Pain Visual Analog scale (VAS), Quality of life by the Short-form 36 (SF-36) questionnaire, Patient Global Assessment, and the Outcome Measures in Rheumatology Committee (OMERACT)-Osteoarthritis Research Society International (OARSI) Responder Index Criteria. Baseline MRI will be performed mainly to exclude meniscal lesions associated with accelerated knee OA. Final (12 month) MRI will be performed to assess structural change in response to treatment
The completion of this project represents a main technological advance, eventually leading to the scalability and enhanced quality control of a much needed treatment, within reasonable costs and logistics, and in particular, with no need of a GMP facility at the point of care or of clinical testing
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's planned enrollment of 60 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Universidad de los Andes, Chile is the lead sponsor of 44 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Cryopreserved "ready to inject" Umbilical Cord (UC) derived MSC
Biological: "Ready to inject" Umbilical cord-derived Mesenchymal Stromal Cell (MSC) product
Umbilical Cord (UC) derived MSC in suspension media
Biological: Resuspended Umbilical cord-derived Mesenchymal Stromal Cell (MSC) product
Cryopreserved thaw \& inject MSC intra-articular therapy
Also known as: Cryopreserved "Ready to inject" MSC product
Cryopreserved resuspended MSC intra-articular therapy
Also known as: Cryopreserved resuspended MSC product
Safety monitoring for Adverse events
Adverse events (AEs) reported for each study group as coded by the Common Terminology Criteria for Adverse Event classification.
Time frame: 12 months
WOMAC scale
Western Ontario and Mc Master Universities Arthritis Index (WOMAC) Spanish validated version. Scale ranges from 0-240 with higher scores indicating worsened state
Time frame: 12 months
Pain Visual Analog Scale (VAS)
VAS scale for pain, ranging from 0-10 with higher scores indicating worsened state
Time frame: 12 months
Quality of Life SF-36 questionnaire
Short-form 36 (SF-36) questionnaire, ranging from 0-100 with higher scores indicating better health status
Time frame: 12 months
Responder status
Assessed by the Outcome Measures in Rheumatology Committee (OMERACT)-Osteoarthritis Research Society International (OARSI) Responder Index Criteria. Responder status requires fulfilling at least 50% improvement in pain or function with absolute change of at least 20; or at least 20% improvemente in pain, function or patient´s global assessment, with absolute change of at least 20.
Time frame: 12 months
WORMS SCORE
Baseline and 12 month MRI will be performed to assess structural change in response to treatment as computed by the Whole-Organ Magnetic Resonance Imaging Score (WORMS) of the knee in osteoarthritis. This score ranges 14 imaging features from 0-332 with higher scores indicating worsened state
Time frame: 12 months
No study locations are listed for this record.
Plan to share: Yes — Sharing upon request after publication of the trial.
Supporting information: Study protocol, Icf, Csr
This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Universidad de los Andes, Chile