Bone Marrow Versus Adipose Autologous Mesenchymal Stem Cells for the Treatment of Knee Osteoarthritis
NCT ID: NCT04351932
Last Updated: 2020-04-17
Study Results
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Basic Information
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UNKNOWN
PHASE3
54 participants
INTERVENTIONAL
2020-06-07
2021-09-07
Brief Summary
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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.
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Detailed Description
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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/)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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bone marrow mesenchymal stem cell
Bone marrow mesenchymal stem cells 10 cc by intra articular injection once
bone marrow mesenchymal stem cells
intrarticular bone marrow mesenchymal stem cells injection
adipose mesenchymal stem cells
Stromal vascular factor from adipose mesenchymal stem cells 10 cc by intra articular injection once
Adipose Mesenchymal stem cells
intrarticular adipose mesenchymal stem cells injection
Bone marrow and Adipose mesenchymal stem cells
Bone marrow and Stromal vascular factor from adipose mesenchymal stem cells 5 cc each one, by intra articular injection once.
bone marrow & adipose mesenchymal stem cells injection
intrarticular bone marrow and adipose stem cells injection.
Interventions
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bone marrow mesenchymal stem cells
intrarticular bone marrow mesenchymal stem cells injection
Adipose Mesenchymal stem cells
intrarticular adipose mesenchymal stem cells injection
bone marrow & adipose mesenchymal stem cells injection
intrarticular bone marrow and adipose stem cells injection.
Eligibility Criteria
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Inclusion Criteria
* Minimal VAS pain score of 4.
* Chronic knee pain of mechanical origin.
* All patients who sign a specially prepared informed consent for this clinical trial.
Exclusion Criteria
* OA grade IV according Ahlbäck classification.
* Bone marrow cancer like lymphoma.
* Severe anemia.
* Active infections.
* Pregnant patients.
* Inmune diseases such as Rheumatoid arthritis, gout or pseudogout arthritis, psoriasis.
* Bone diseases such as Kahler and Paget.
* Corticoesteroid and hyaluronic injections within the last 3 months.
* Knee surgery in the last 6 months.
18 Years
70 Years
ALL
No
Sponsors
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Maastricht University Medical Center
OTHER
Universidad Catolica Santiago de Guayaquil
OTHER
Responsible Party
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Dr. Carlos Chiriboga Accini
Research Professor. Orthopaedic Staff. Omnihospital.
Principal Investigators
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Carlos A Chiriboga, MD
Role: PRINCIPAL_INVESTIGATOR
Universidad Católica Santiago de Guayaquil
Locations
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Omnihospital
Guayaquil, Guayas, Ecuador
Countries
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Central Contacts
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Facility Contacts
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References
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Wagner W, Wein F, Seckinger A, Frankhauser M, Wirkner U, Krause U, Blake J, Schwager C, Eckstein V, Ansorge W, Ho AD. Comparative characteristics of mesenchymal stem cells from human bone marrow, adipose tissue, and umbilical cord blood. Exp Hematol. 2005 Nov;33(11):1402-16. doi: 10.1016/j.exphem.2005.07.003.
Wakitani S, Imoto K, Yamamoto T, Saito M, Murata N, Yoneda M. Human autologous culture expanded bone marrow mesenchymal cell transplantation for repair of cartilage defects in osteoarthritic knees. Osteoarthritis Cartilage. 2002 Mar;10(3):199-206. doi: 10.1053/joca.2001.0504.
Xia P, Wang X, Lin Q, Li X. Efficacy of mesenchymal stem cells injection for the management of knee osteoarthritis: a systematic review and meta-analysis. Int Orthop. 2015 Dec;39(12):2363-72. doi: 10.1007/s00264-015-2785-8. Epub 2015 May 6.
Wakitani S, Okabe T, Horibe S, Mitsuoka T, Saito M, Koyama T, Nawata M, Tensho K, Kato H, Uematsu K, Kuroda R, Kurosaka M, Yoshiya S, Hattori K, Ohgushi H. Safety of autologous bone marrow-derived mesenchymal stem cell transplantation for cartilage repair in 41 patients with 45 joints followed for up to 11 years and 5 months. J Tissue Eng Regen Med. 2011 Feb;5(2):146-50. doi: 10.1002/term.299.
Jo CH, Lee YG, Shin WH, Kim H, Chai JW, Jeong EC, Kim JE, Shim H, Shin JS, Shin IS, Ra JC, Oh S, Yoon KS. Intra-articular injection of mesenchymal stem cells for the treatment of osteoarthritis of the knee: a proof-of-concept clinical trial. Stem Cells. 2014 May;32(5):1254-66. doi: 10.1002/stem.1634.
Peeters CM, Leijs MJ, Reijman M, van Osch GJ, Bos PK. Safety of intra-articular cell-therapy with culture-expanded stem cells in humans: a systematic literature review. Osteoarthritis Cartilage. 2013 Oct;21(10):1465-73. doi: 10.1016/j.joca.2013.06.025. Epub 2013 Jul 4.
Freitag J, Bates D, Boyd R, Shah K, Barnard A, Huguenin L, Tenen A. Mesenchymal stem cell therapy in the treatment of osteoarthritis: reparative pathways, safety and efficacy - a review. BMC Musculoskelet Disord. 2016 May 26;17:230. doi: 10.1186/s12891-016-1085-9.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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UCSantiagodeGuayaquil001
Identifier Type: -
Identifier Source: org_study_id
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