A Phase 3 interventional study of bone marrow mesenchymal stem cells and Adipose Mesenchymal stem cells in Osteo Arthritis Knee, sponsored by Universidad Catolica Santiago de Guayaquil. Status unknown at 1 site in Ecuador. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-04-17.
Sponsored by Universidad Catolica Santiago de Guayaquil · Phase 3, Interventional, and Treatment
Mesenchymal stem cells (MSC) are stromal cells that have the ability to self-renew and also exhibit multilineage differentiation. MSCs can be isolated from a variety of tissues, such as umbilical cord, bone marrow, and adipose tissue. The multipotent properties of MSCs make them a promising option for the treatment of osteoarthritis (OA).
Bone marrow mesenchymal stem cells (BM-MSC) and adipose derived mesenchymal stem cells (AD-MSC) have been used separately to treat OA. The aim of the present study will be to compare in a randomized non blind controlled clinical trial 3 types of intra-articular injections containing MSC populations obtained from two clinically relevant sources: BM-MSC, AD-MSC and a combination of both BM-MSC and AD-MSC.
The aim of the present study will be to compare 3 types of intra-articular injections of MSC populations obtained from two clinically relevant sources: injections containing BM-MSC or AD-MSC or a combination of both BM-MSC,and AD-MSC in a randomized non blind clinical trial.
To assess the efficacy and safety of 3 kind of MSC injections in relation to pain, function and quality of life in patients with knee OA.
A total of 54 patients with the diagnosis of knee OA grade II and III will be recruited to receive a single intra-articular injection of MSC: Group 1 (n 18 patients) will receive BM-MSC, Group 3 (n 18 patients) will receive AD-MSC. Group 3 (18 patients) will receive a combination of BM-MSC and AD-MSC.
A randomized non blind clinical trial with active control. For this purpose, the random number generator is 54, found on the RANDOM.ORG ® website (available at https://www.random.org/integers/)
Universidad Catolica Santiago de Guayaquil is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bone marrow mesenchymal stem cells 10 cc by intra articular injection once
Biological: bone marrow mesenchymal stem cells
Stromal vascular factor from adipose mesenchymal stem cells 10 cc by intra articular injection once
Biological: Adipose Mesenchymal stem cells
Bone marrow and Stromal vascular factor from adipose mesenchymal stem cells 5 cc each one, by intra articular injection once.
Biological: bone marrow & adipose mesenchymal stem cells injection
intrarticular bone marrow mesenchymal stem cells injection
intrarticular adipose mesenchymal stem cells injection
intrarticular bone marrow and adipose stem cells injection.
knee pain assessed by Visual Analogue Scale.
psychometric response scale which used in questionnaires. It is a measurement instrument for subjective characteristics of pain . Score from O to 10. O indicate no pain, and 10 indicate the worst pain.
Time frame: 12 months
knee function assessed by WOMAC (Wester Ontario McMaster Osteoarthritis Index). quosteionary.
The Index contains 24 questions five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). Individual question responses are assigned a score of between 0 (extreme) and 4 (None). Individual question scores are then summed to form a raw score ranging from 0 (worst) to 96 (best). Finally, raw scores are normalized by multiplying each score by 100/96. This produces a reported WOMAC Score of between 0 (worst) to 100 (best).
Time frame: 12 months
Quantitative T2-Mapping Evaluation of Changes in Cartilage Matrix
MRI T2 mapping of the cartilage is a non-invasive functional imaging technique delivering cartography of the T2 relaxation time of the cartilage without any contrast injection. It is sensitive to tissue anisotropy, and provides compositional information on the cartilage collagen network, water content and proteoglycans concentration.
Time frame: 6 months after procedure
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — all IPD that underlie results in a publication
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: JUNE 2021 TO SEPTEMBER 2021
Access criteria: drcarloschiriboga@gmail.com
This study is status unknown, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Universidad Catolica Santiago de Guayaquil