Ignite Creation Date:
2024-05-06 @ 4:05 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04863183
Status:
UNKNOWN
Last Update Posted:
2021-04-28
First Post:
2021-04-20
Brief Title:
Cell Therapy With Cellistem-OA for Symptomatic Knee Osteoarthritis
Sponsor:
Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle
Organization:
Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle
Study Overview
Official Title:
Cell Therapy for Patients With Symptomatic Knee Osteoarthritis Phase I II Controlled Randomized and Double-blind Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2021-04
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Symptomatic knee osteoarthritis is a serious public health problem in the world it carries a high personal social and economic impact Currently there are no drugs that modify the natural course of the disease As analgesic therapy becomes insufficient more invasive measures are applied ultimately leading to arthroplasty
The scientific community has joined efforts to develop new therapeutic approaches that allow the delay and regeneration of injured tissue in these patients These include cell therapy with mesenchymal stem cells derived from different sources Although most of the clinical studies carried out in different parts of the world with this therapy in patients with knee osteoarthritis have shown therapeutic benefit it is necessary to develop clinical trials with high quality in our population
The aim of this project is to evaluate the safety tolerance and efficacy of Cellistem-OA biological therapy based on mesenchymal stem cells derived from Whartons jelly of umbilical cord in patients with knee osteoarthritis in the Colombian population
Investigators proposed to carry out an experimental clinical trial randomized controlled and parallel with 30 participants with knee knee osteoarthritis of the medical complex Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle The participants will be randomized into two groups i 15 patients who will receive a dose of 2 x 106 Cellistem-OA and ii 15 patients who will receive an active comparator acetonide of triamcinolone 10mg mL which will be administered by intra-articular injection in the superolateral aspect of the knee The outcomes to be evaluated will be i decrease in joint pain ii increase in joint functionality iii improvement in quality of life and iv improvement of articular cartilage These parameters will be evaluated at weeks 1 4 8 12 24 25 28 32 36 and 52 post-treatments Additionally local and systemic adverse events will be recorded to establish whether or not there is an association between them and the intervention
The scientific community has joined efforts to develop new therapeutic approaches that allow the delay and regeneration of injured tissue in these patients These include cell therapy with mesenchymal stem cells derived from different sources Although most of the clinical studies carried out in different parts of the world with this therapy in patients with knee osteoarthritis have shown therapeutic benefit it is necessary to develop clinical trials with high quality in our population
The aim of this project is to evaluate the safety tolerance and efficacy of Cellistem-OA biological therapy based on mesenchymal stem cells derived from Whartons jelly of umbilical cord in patients with knee osteoarthritis in the Colombian population
Investigators proposed to carry out an experimental clinical trial randomized controlled and parallel with 30 participants with knee knee osteoarthritis of the medical complex Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle The participants will be randomized into two groups i 15 patients who will receive a dose of 2 x 106 Cellistem-OA and ii 15 patients who will receive an active comparator acetonide of triamcinolone 10mg mL which will be administered by intra-articular injection in the superolateral aspect of the knee The outcomes to be evaluated will be i decrease in joint pain ii increase in joint functionality iii improvement in quality of life and iv improvement of articular cartilage These parameters will be evaluated at weeks 1 4 8 12 24 25 28 32 36 and 52 post-treatments Additionally local and systemic adverse events will be recorded to establish whether or not there is an association between them and the intervention
Detailed Description:
Type of study Controlled randomized double-blind clinical trial comparing CELLISTEM-OA and active comparator triamcinolone acetonide
Study population Patients from the Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle who consult the trauma and rheumatology service by knee osteoarthritis Patients who show interest in participating will be cited to an interview with the researchers where both the objectives and the research procedures will be explained
Sample size The sample size considered are 30 participants distributed in two groups
Group 1 control active comparator triamcinolone acetonide 10mg mL via intra-articular 5 cc
Group 2 experimental CELLISTEM-OA via intra-articular doses of 2 x 106 cells in 5cc of saline solution
The intra-articular puncture will be performed by an orthopedic doctor specializing in knee and hip treatments using sterile technique after cooling the skin with local ice
Study population Patients from the Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle who consult the trauma and rheumatology service by knee osteoarthritis Patients who show interest in participating will be cited to an interview with the researchers where both the objectives and the research procedures will be explained
Sample size The sample size considered are 30 participants distributed in two groups
Group 1 control active comparator triamcinolone acetonide 10mg mL via intra-articular 5 cc
Group 2 experimental CELLISTEM-OA via intra-articular doses of 2 x 106 cells in 5cc of saline solution
The intra-articular puncture will be performed by an orthopedic doctor specializing in knee and hip treatments using sterile technique after cooling the skin with local ice
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None