Treatment of Knee Osteoarthritis by Intra-articular Injection of Bone Marrow Mesenchymal Stem Cells
NCT ID: NCT02123368
Last Updated: 2017-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2012-05-31
2015-02-28
Brief Summary
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Patients and methods
Clinical trial phase I- II, randomized , multicenter , with three treatment arms and 10 patients for each group. The investigators compare the intraarticular injection of hialuronic acid against the administration of two different doses of mesenchymal stem cells with hialuronic acid according to the following scheme:
1. Group A: intra-articular injection of hyaluronic acid (Hyalone®). Single dose.
2. Group B: Low Dosage of MSCs . Intra-articular injection of 10 million autologous mesenchymal progenitor stem cells cultured ex - vivo (cell suspension sterile small volume (5-10 ml ) in a vehicle suitable for intraarticular injection ) followed by an intraarticular injection Hiaurónico Acid ( Hyalone®).
3. Group C : High dose of MSCs. Intra-articular injection of 100 million autologous mesenchymal progenitor stem cells cultured ex - vivo ( cell suspension sterile small volume (5-10 ml ) in a vehicle suitable for intraarticular injection ) followed by an intraarticular injection Hiaurónico Acid (Hyalone®).
The primary endpoint is safety and feasibility. The investigators registered the occurrence of complications and / or adverse effects during the study.
In addition the investigators assess the response to intra-articular infusion of CMM analyzing the following parameters:
* Clinical assessment of pain and function (Baseline, 1, 3, 6 and 12 months since treatment): VAS , WOMAC , KOOS , EuroQol, SF-16, Lequesne , WOMAC , KOOS.
* Radiographic (baseline, 6 and 12 months since treatment): Femorotibial space.
* Radiographic using MRI (baseline, 6 and 12 months since treatment): by assessing the number location of the lesions , cartilage thickness , signal intensity , subchondral bone alteration , volume and WORMS and dGEMRIC protocols.
Detailed Description
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Patients and methods
Clinical trial phase I- II, randomized , multicenter , with three treatment arms and 10 patients for each group. The investigators compare the intraarticular injection of hialuronic acid against the administration of two different doses of mesenchymal stem cells with hialuronic acid according to the following scheme:
1. Group A: intra-articular injection of hyaluronic acid (Hyalone®). Single dose.
2. Group B: Low Dosage of MSCs . Intra-articular injection of 10 million autologous mesenchymal progenitor stem cells cultured ex - vivo (cell suspension sterile small volume (5-10 ml ) in a vehicle suitable for intraarticular injection ) followed by an intraarticular injection Hiaurónico Acid ( Hyalone®).
3. Group C : High dose of MSCs. Intra-articular injection of 100 million autologous mesenchymal progenitor stem cells cultured ex - vivo ( cell suspension sterile small volume (5-10 ml ) in a vehicle suitable for intraarticular injection ) followed by an intraarticular injection Hiaurónico Acid (Hyalone®).
The autologous mesenchymal stem cells are obtained from the iliac crest and cultured ex vivo under local anesthesia and sedation.
The primary endpoint is safety and feasibility. The investigators registered the occurrence of complications and / or adverse effects during the study.
In addition the investigators assess the response to intra-articular infusion of CMM analyzing the following parameters:
* Clinical assessment of pain and function (Baseline, 1, 3, 6 and 12 months since treatment): VAS , WOMAC , KOOS , EuroQol, SF-16, Lequesne , WOMAC , KOOS.
* Radiographic (baseline, 6 and 12 months since treatment): Femorotibial space.
* Radiographic using MRI (baseline, 6 and 12 months since treatment): by assessing the number location of the lesions , cartilage thickness , signal intensity , subchondral bone alteration , volume and WORMS and dGEMRIC protocols.
All patients met the following inclusion and exclusion criteria:
Inclusion Criteria:
* Males and females between 50 and 80 year old.
* Diagnosis of knee OA according to the criteria of osteoarthritis of the ACR (American College of Rheumatology).
* Joint pain equal or greater than 2.5 points on the visual analogue scale (VAS).
* Radiological Classification: Kellgren-Lawrence scale greater or equal to 2.
* Body mass index between 20 and 35 kg/m2.
* Ability to follow during the study period.
Exclusion Criteria:
* Bilateral Osteoarthritis of the Knee requiring treatment in both knees.
* Previous diagnosis of polyarticular disease.
* Severe mechanical deformation.
* Arthroscopy during the previous 6 months.
* Intraarticular infiltration of hyaluronic acid in the last 6 months.
* Systemic autoimmune rheumatic disease.
* Poorly controlled diabetes mellitus.
* Blood dyscrasias.
* Immunosuppressive or anticoagulant treatments.
* Treatment with corticosteroids in the 3 months prior to inclusion in the study.
* NSAID therapy within 15 days prior to inclusion in the study.
* Patients with a history of allergy to penicillin or streptomycin.
* Allergy to hyaluronic acid or poultry proteins.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Hialuronic acid
Single intraarticular injection of Hyaluronic acid (Hyal One)
Hyaluronic acid
Single intraarticular injection of Hyaluronic acid (Hyal One)
Hyaluronic acid and MSC 10
Single intraarticular injection of Hyaluronic acid (Hyal One) 10 million Bone marrow mesenchimal stem cells
Hyaluronic acid
Single intraarticular injection of Hyaluronic acid (Hyal One)
10 million Bone marrow mesenchimal stem cells
10 million of Bone marrow mesenchimal stem cells
Hyaluronic acid AND MSC 100
Single intraarticular injection of Hyaluronic acid (Hyal One) 100 million Bone marrow mesenchimal stem cells
Hyaluronic acid
Single intraarticular injection of Hyaluronic acid (Hyal One)
100 million Bone marrow mesenchimal stem cells
100 million of Bone marrow mesenchimal stem cells
Interventions
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Hyaluronic acid
Single intraarticular injection of Hyaluronic acid (Hyal One)
10 million Bone marrow mesenchimal stem cells
10 million of Bone marrow mesenchimal stem cells
100 million Bone marrow mesenchimal stem cells
100 million of Bone marrow mesenchimal stem cells
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of knee OA according to the criteria of osteoarthritis of the ACR (American College of Rheumatology).
* Joint pain equal or greater than 2.5 points on the visual analogue scale (VAS).
* Radiological Classification: Kellgren-Lawrence scale greater or equal to 2.
* Body mass index between 20 and 35 kg/m2.
* Ability to follow during the study period.
Exclusion Criteria
* Previous diagnosis of polyarticular disease.
* Severe mechanical deformation.
* Arthroscopy during the previous 6 months.
* Intraarticular infiltration of hyaluronic acid in the last 6 months.
* Systemic autoimmune rheumatic disease.
* Poorly controlled diabetes mellitus.
* Blood dyscrasias.
* Immunosuppressive or anticoagulant treatments.
* Treatment with corticosteroids in the 3 months prior to inclusion in the study.
* NSAID therapy within 15 days prior to inclusion in the study.
* Patients with a history of allergy to penicillin or streptomycin.
* Allergy to hyaluronic acid or poultry proteins.
50 Years
80 Years
ALL
No
Sponsors
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Clinica Universidad de Navarra, Universidad de Navarra
OTHER
Responsible Party
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Principal Investigators
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José Lamo-Espinosa, MD
Role: PRINCIPAL_INVESTIGATOR
Clinica Universidad de Navarra
Felipe Prosper, MD PhD
Role: STUDY_DIRECTOR
Clinica Universidad de Navarra
Juan Blanco, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University of Salamanca
Locations
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Traumatology department. Complejo Hospitalario de Salamanca
Salamanca, Castille and León, Spain
Orthopaedic and traumatology department. Clínica Universidad de Navarra
Pamplona, Navarre, Spain
Countries
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References
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Lamo-Espinosa JM, Prosper F, Blanco JF, Sanchez-Guijo F, Alberca M, Garcia V, Gonzalez-Vallinas M, Garcia-Sancho J. Long-term efficacy of autologous bone marrow mesenchymal stromal cells for treatment of knee osteoarthritis. J Transl Med. 2021 Dec 11;19(1):506. doi: 10.1186/s12967-021-03160-2.
Lamo-Espinosa JM, Mora G, Blanco JF, Granero-Molto F, Nunez-Cordoba JM, Lopez-Elio S, Andreu E, Sanchez-Guijo F, Aquerreta JD, Bondia JM, Valenti-Azcarate A, Del Consuelo Del Canizo M, Villaron EM, Valenti-Nin JR, Prosper F. Intra-articular injection of two different doses of autologous bone marrow mesenchymal stem cells versus hyaluronic acid in the treatment of knee osteoarthritis: long-term follow up of a multicenter randomized controlled clinical trial (phase I/II). J Transl Med. 2018 Jul 31;16(1):213. doi: 10.1186/s12967-018-1591-7.
Lamo-Espinosa JM, Mora G, Blanco JF, Granero-Molto F, Nunez-Cordoba JM, Sanchez-Echenique C, Bondia JM, Aquerreta JD, Andreu EJ, Ornilla E, Villaron EM, Valenti-Azcarate A, Sanchez-Guijo F, Del Canizo MC, Valenti-Nin JR, Prosper F. Intra-articular injection of two different doses of autologous bone marrow mesenchymal stem cells versus hyaluronic acid in the treatment of knee osteoarthritis: multicenter randomized controlled clinical trial (phase I/II). J Transl Med. 2016 Aug 26;14(1):246. doi: 10.1186/s12967-016-0998-2.
Related Links
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University clinic of navarre trial information
Other Identifiers
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2009-017624-72
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CMM/ART
Identifier Type: -
Identifier Source: org_study_id