Table 15 Clinical trials (unpublished/on-going) registered in ClinicalTrials.gov
From: The use of mesenchymal stem cells for cartilage repair and regeneration: a systematic review
Title | Cell source | Country | Clinical trial phase | Condition | Study design | Enrolment | Follow-up | Arm(s) | Cell delivery | Primary outcomes | Study status (on 8.3.2016) | ClinicalTrials.gov Identifier |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
Autologous cells | ||||||||||||
Mesenchymal Stem Cells in Knee Cartilage Injuries | Bone marrow | Jordan | II | Advanced knee articular cartilage injury | Non-randomized parallel assignment; double blind | 13 | 12 months | Culture expanded MSCs alone vs. MSC with platelet lysate | Intra-articular injection | Therapeutic benefit | Completed in August 2015; no publication found | NCT02118519 |
Adult Stem Cell Therapy for Repairing Articular Cartilage in Gonarthrosis | Bone marrow | Spain | I/II | Gonarthrosis grade 2–3 | Open label; single group assignment | 15 | 12 months | Culture expanded MSCs (40 million cells) | Articular injection | Feasibility/safety | Completed in January 2013; no publication found | NCT01227694 |
Autologous Bone Marrow Mesenchymal Stem Cells Transplantation for Articular Cartilage Defects Repair | Bone marrow | UK | I/II | Knee articular cartilage defects | Randomized parallel assignment; double blind | 10 | 12 months | MSCs (fresh or cultured unspecified) | Intra-articular injection | Change in WOMAC | Unknown (estimated study completion date; July 2014) | NCT01895413 |
Mesenchymal Stem Cell for Osteonecrosis of the Femoral Head | Bone marrow | China | 0 | Osteochondritis of the femoral head | Open label single group assignment | 15 | 5 years | Culture expanded MSC and bone marrow nuclear cells | Infusion through medial femoral circumflex artery, lateral femoral circumflex artery and obturator artery | Femoral head blood-supply artery angiographies; femoral head necrosis | Unknown (estimated study completion date; August 2015) | NCT00813267 |
The Effects of Intra-articular Injection of Mesenchymal Stem Cells in Knee Joint Osteoarthritis | Bone marrow | Iran | II | Knee joint osteoarthritis | Single centre, randomised, placebo controlled, double blind | 40 | 3 months | Culture-expanded MSCs vs. placebo | Intra-articular injection | Changes in WOMAC physical function and VAS pain | Completed in November 2012; no publication found | NCT01504464 |
Safety and Efficacy of Autologous Bone Marrow Stem Cells for Treating Osteoarthritis | Bone marrow | India | I/II | Knee OA Kellgren and Lawrence classification 3–4 | Open label single group assignment; multi-centre | 10 | 1 year | MSCs (fresh or culture-expanded unspecified) | Unknown | WOMAC pain score and safety | On-going (estimated study completion date; January 2012) | NCT01152125 |
Treatment of Knee Osteoarthritis by Intra-articular Injection of Bone Marrow Mesenchymal Stem Cells | Bone marrow | Spain | I/II | Knee OA | Randomised parallel assignment; open label | 30 | 12 months | Culture-expanded MSCs (10 million or 100 million cells) and hyaluronic acid (HyalOne®) vs. HyalOne® | Intra-articular injection | Pain and function (VAS, WOMAC, KOOS, EuroQol, SF-16, Lequesne), radiographic | On-going (estimated study completion date; February 2015) | NCT02123368 |
Intra-Articular Autologous Bone Marrow Mesenchymal Stem Cells Transplantation to Treat Mild to Moderate Osteoarthritis | Bone marrow | Malaysia | II | Mild to moderate OA based on Kellgren-Lawrence radiographic classification | Randomised parallel assignment; open label | 50 | 12 months | MSCs (fresh or culture-expanded unspecified) in hyaluronic acid “Orthovisc” vs. hyaluronic acid | Intra-articular implantation | Changes in cartilage thickness (MRI) | Unknown (estimated study completion date; March 2014) | NCT01459640 |
Treatment of Osteoarthritis by Intra-articular Injection of Bone Marrow Mesenchymal Stem Cells With Platelet Rich Plasma (CMM-PRGF/ART) | Bone marrow | Spain | I/II | Knee OA | Randomised parallel assignment; open label; multi-centre | 38 | 12 months | Culture-expanded MSCs with PRP (PRGF®) vs. PRGF® only | Intra-articular injection | Pain and function (VAS, WOMAC, KOOS, EuroQol, SF-16, Lequesne), radiographic | On-going (estimated study completion date; June 2017) | NCT02365142 |
Mesenchymal Stem Cells Enhanced With PRP Versus PRP In OA Knee (MSCPRPOAK) | Bone marrow | India | I/II | Knee OA grade 1–2 Ahlbacks radiographic staging | Randomised parallel assignment double blinded | 24 | 6 months | Culture-expanded MSCs (10 million cells) with autologous PRP vs. PRP only | Injected by lateral approach | VAS pain | Unknown (estimated study completion date; June 2014) | NCT01985633 |
Side Effects of Autologous Mesenchymal Stem Cell Transplantation in Ankle Joint Osteoarthritis | Bone marrow | Iran | I | Severe ankle OA | Single group assignment open label | 6 | 6 months | Culture-expanded MSCs | Intra-articular injection | Safety | Completed in September 2011; no publication found | NCT01436058 |
Human Autologous MSCs for the Treatment of Mid to Late Stage Knee OA | Bone marrow | Canada | I/II | Mid- to late-stage knee OA | Single group assignment, open label | 12 | 1 year | Culture-expanded MSCs (1 million, 10 million or 50 million cells) | Injection | Safety | On-going (estimated study completion date; February 2021) | NCT02351011 |
A Controlled Surveillance of the Osteoarthritic Knee Microenvironment With Regenexx® SD Treatment | Bone marrow | USA | NA | Knee OA Kellgren-Lawrence grade 2 or greater | Observational cohort study | 20 | 6 weeks | Regenexx® SD (bone marrow concentrate) | Injection | Temporal median change in protein concentration or percentage of cellular subpopulations | On-going (estimated study completion date; March 2016) | NCT02370823 |
The Effect of Platelet-rich Plasma in Patients With Osteoarthritis of the Knee | Bone marrow | Iran | III | Knee OA grade 2 and above (radiographic) | Randomised, parallel assignment, placebo controlled, double blinded | 50 | 2 year | Bone marrow aspirate vs. placebo (saline) | Intra-articular injection | VAS pain, WOMAC physical activity, cartilage repair (MRI) | Completed in April 2014; no publication found | NCT02582489 |
Outcomes Data of Bone Marrow Stem Cells to Treat Hip and Knee Osteoarthritis | Bone marrow | USA | NA | Hip and knee OA | Observational cohort study | 12 | 1 year | Bone marrow concentrate | Injection | VAS pain, Harris Hip Score or Knee Society Score, Physician Global Assessment | Completed in March 2014; no publication found | NCT01601951 |
Use of Autologous Bone Marrow Aspirate Concentrate in Painful Knee Osteoarthritis (BMAC) | Bone marrow | USA | II | Bilateral knee OA Kellgren-Lawrence grade 1–3 | Randomised, parallel assignment, placebo controlled, single blinded | 25 | 12 months | Bone marrow concentrate vs. placebo (saline) | Injection | Safety | On-going (estimated study completion date; December 2016) | NCT01931007 |
Autologous Stem Cells in Osteoarthritis | Bone marrow | Mexico | I | Knee OA Kellgren-Lawrence radiographic scale grade 2–3 | Randomised parallel assignment, open label | 61 | 6 months | Hematopoietic stem cells (fresh) vs. acetaminophen (750 mg orally TID) | Infusion | Safety | Completed in May 2014; no publication found | NCT01485198 |
The Use of Autologous Bone Marrow Mesenchymal Stem Cells in the Treatment of Articular Cartilage Defects | Bone marrow | Egypt | Not given | An isolated osteochondral defect with no more than grade 1 or 2 Outerbridge | Single group assignment, open label | 25 | 12 months | Culture-expanded MSCs | Open surgery or arthroscopy | Clinical scores and radiological images | Unknown (estimated study completion date; December 2014) | NCT00891501 |
Autologous Transplantation of Mesenchymal Stem Cells (MSCs) and Scaffold in Full-thickness Articular Cartilage | Bone marrow | Iran | I | Full-thickness chondral defects | Single group assignment, open label | 6 | 12 months | Culture-expanded MSCs mixed with collagen I scaffold | Unspecified | Knee cartilage defects | Completed in December 2010; no publication found | NCT00850187 |
“One-step” Bone Marrow Mononuclear Cell Transplantation in Talar Osteochondral Lesions (BMDC) | Bone marrow | USA | III | ICRS grade 3–4 Osteochondral lesions of the talar dome | Single group assignment, open label | 140 | 24 months | Bone marrow concentrate | Arthroscopy | American Orthopaedic Foot and Ankle Society hindfoot score | On-going (estimated completion date; June 2016) | NCT02005861 |
Transplantation of Bone Marrow Stem Cells Stimulated by Proteins Scaffold to Heal Defects Articular Cartilage of the Knee | Bone marrow | France | 0 | Knee OA ICRS classification grade 4 | Single group assignment, open label | 50 | 1 year | Freshly isolated bone marrow mononuclear cells mixed with protein scaffold | Arthroscopy (one step procedure) | IKS | Unknown (estimated completion date; December 2014)) | NCT01159899 |
INSTRUCT for Repair of Knee Cartilage Defects | Bone marrow | The Netherlands | Not given | Knee articular cartilage defect | Single group assignment, open label; multi-centre | 40 | 1 year | INSTRUCT scaffold (biodegradable scaffold seeded with autologous primary chondrocytes and bone marrow cells) | Arthrotomy | Safety and lesion filling | Completed in June 2014; no publication found | NCT01041885 |
HyaloFAST Trial for Repair of Articular Cartilage in the Knee (FastTRACK) | Bone marrow | Hungary | Not given | Knee articular cartilage defect | Randomised, parallel assignment, placebo controlled, single blinded, multi-centre | 200 | 2 years | Hyalofast® scaffold with bone marrow aspirate concentrate vs. microfracture | One-step arthroscopic procedure | Changes in KOOS | On-going (estimated study completion date; June 2020) | NCT02659215 |
Autologous Adipose Stem Cells and Platelet Rich Plasma Therapy for Patients With Knee Osteoarthritis | Adipose | Vietnam | I/II | Idiopathic or secondary knee OA grade 2–3 radiographic severity | non-randomised unblinded | 16 | 12 months | Stromal vascular fraction (10–50 million cells) and platelet rich plasma (PRP) | Injection | Safety | Completed in December 2015; no publication found | NCT02142842 |
Effectiveness and Safety of Autologous ADRC for Treatment of Degenerative Damage of Knee Articular Cartilage | Adipose | Russia | I/II | Knee OA (degenerative damage of knee articular cartilage) | Single group assignment, open label | 12 | 24 weeks | Adipose-derived regenerative cells (ADRC) extracted using Celution 800/CRS System (Cytori Therapeutics, Inc.) | Intra-articular injection | Safety | On-going (estimated study completion date; December 2016) | NCT02219113 |
Autologous Adipose-Derived Stromal Cells Delivered Intra-articularly in Patients With Osteoarthritis | Adipose | USA | I/II | OA | Single group assignment, open label, multi-centre | 500 | 6 months | MSCs in PRP | Intra-articular injection | Pain score, functional rating index, visual analogue scale (VAS), physical therapy (PT) and range of motion (53), quality of life scores, reduction in analgesics, adverse events | On-going (estimated study completion date; December 2016) | NCT01739504 |
Mesenchymal Stem Cell Treatment for Primary Osteoarthritis Knee | Adipose | Taiwan | I | Bilateral primary OA Kellgren and Lawrence grade 2–3 as determined by X-ray | Single group assignment, open label, | 10 | 12 months | MSCs (8–10 million cells) | Intra-articular injections | Safety | On-going (estimated study completion date; December 2016) | NCT02544802 |
Autologous Adipose Tissue-Derived Mesenchymal Progenitor Cells Therapy for Patients With Knee Osteoarthritis | Adipose | China | II | Knee OA | Single group assignment, double blinded | 48 | 6 months | Fresh MSCs (10 million, 20 million, 50 million cells twice) vs. placebo (PBS) | Intra-articular injection | WOMAC score | Completed in December 2013; no publication found | NCT01809769 |
Clinical Trial of Autologous Adipose Tissue-Derived Mesenchymal Progenitor Cells (MPCs) Therapy for Knee Osteoarthritis | Adipose | China | II | Knee OA | Randomised, parallel assignment, placebo controlled, single blinded | 48 | 12 months | Culture-expanded MSCs vs. sodium hyaluronate | Intra-articular injection | WOMAC | On-going (estimated study completion date; July 2016) | NCT02162693 |
Outcomes Data of Adipose Stem Cells to Treat Osteoarthritis | Adipose | USA | NA | Knee OA | Observational cohort study | 50 | 12 months | Cellular concentrate | Unknown | KOOS, HOOS | On-going (estimated study completion date; September 2017) | NCT02241408 |
Clinical Trial to Evaluate Efficacy and Safety of JOINTSTEM in Patients With Degenerative Arthritis | Adipose | Korea | II/III | Knee OA | Randomised parallel assignment, double blinded | 120 | 24 weeks | MSCs (100 million cells) vs. sodium chloride | Injection | WOMAC | On-going (estimated study completion date; July 2017) | NCT02658344 |
ADIPOA–Clinical Study | Adipose | France | I | Moderate or severe knee OA | Non-randomised parallel assignment, open label | 12 | 1 year | MSCs (2 million, 10 million, 50 million cells) | Intra-articular injection | Safety | Completed in December 2014; no publication found | NCT01585857 |
Safety and Clinical Effectiveness of A3 SVF in Osteoarthritis | Adipose | USA | Not given | OA | Single group assignment, open label | 30 | 1 year | Stromal vascular fraction with activated platelet | Injection | Pain and inflammation–WOMAC scores, comprehensive inflammation blood panel | On-going (estimated study completion date; September 2015) | NCT01947348 |
Safety and Clinical Outcomes Study: SVF Deployment for Orthopaedic, Neurologic, Urologic, and Cardio-pulmonary Conditions | Adipose | USA | Not given | Neurodegenerative diseases, OA, erectile dysfunction, autoimmune diseases, cardiomyopathies or emphysema | Single group assignment, open label | 3000 | 36 months | Stromal vascular fraction | Intra-venous, intra-articular, and soft tissue injection | Safety | On-going (estimated study completion date; March 2018) | NCT01953523 |
Microfracture Versus Adipose-Derived Stem Cells for the Treatment of Articular Cartilage Defects | Adipose | USA | Not given | Knee OA | Randomised, parallel assignment, double blind | 90 | 24 months | Fibrin glue + acellular collagen dermal matrix + DSCs, + additional layer of fibrin glue vs. microfracture | Arthroscopy | KOOS | On-going (estimated study completion date; December 2020) | NCT02090140 |
Autologous Mesenchymal Stem Cells vs. Chondrocytes for the Repair of Chondral Knee Defects (ASCROD) | Adipose | Spain | I/II | Articular cartilage lesion of the femoral condyle | Randomised, parallel assignment, open label | 30 | 18 months | Cultured stem cells vs. cultured autologous chondrocytes | Unknown | Hyaline cartilage production for chondral knee lesions repair | Unknown (estimated study completion date; June 2012) | NCT01399749 |
A Phase 2 Study to Evaluate the Efficacy and Safety of JointStem in Treatment of Osteoarthritis | Adipose | USA | II | Knee OA | Randomised, parallel assignment, double blinded | 45 | 6 months | Joint stem adipose-derived (MSCs) vs. Synvisc-One (hyaluronic acid) | Cartilage volume, cartilage articular surface area, cartilage thickness, subchondral bone surface curvature (MRI) | On-going (estimated study completion date; September 2017) | NCT02674399 | |
Allogenic cells | ||||||||||||
Treatment of Knee Osteoarthritis With Allogenic Mesenchymal Stem Cells (MSV_allo) | Bone marrow | Spain | I/II | Knee OA grade 2–4 of Kellgren and Lawrence | Randomised, parallel assignment, double blinded | 30 | 1 years | Culture-expanded MSCs (40 million cells) vs. hyaluronic acid | Intra-articular transplantation | Safety | Completed in June 2014; published in August 2015 | NCT01586312 (Linked to study NCT01183728) |
Clinical Trial of Allogenic Adipose Tissue-Derived Mesenchymal Progenitor Cells Therapy for Knee Osteoarthritis | Adipose | China | I | Degenerative arthritis by radiographic criteria of Kellgren Lawrence | Randomised, parallel assignment, double blind | 18 | 48 weeks | 10 million MSCs vs. 20 million MSCs | Intra-articular injection | WOMAC | On-going (estimated study completion date; July 2017) | NCT02641860 |
Clinical Study of Umbilical Cord Tissue Mesenchymal Stem Cells (UC-MSC) for Treatment of Osteoarthritis | Umbilical Cord | Panama | I/II | Modified Kellgren-Lawrence classification grade 2–4 radiographic OA severity. | Randomised, parallel assignment, open label | 40 | 12 months | Single intra-articular injection of MSCs vs. IV injections of MSC for 3 days | Intra-articular injection; IV | Safety | On-going (estimated study completion date; March 2017) | NCT02237846 |
Safety and Feasibility Study of Mesenchymal Trophic Factor (MTF) for Treatment of Osteoarthritis | Umbilical Cord | Panama | I/II | Modified Kellgren-Lawrence classification grade 2–4 radiographic OA severity. | Non-Randomised, single group assignment, open label | 40 | 12 months | Intra-articular injection of allogeneic MTF from UC-MSC vs. 12 subcutaneous MTF injections, once per week | Intra-articular injection; subcutaneous injection | Safety | On-going (estimated study completion date; June 2017) | NCT02003131 |
A Study to Assess Safety and Efficacy of Umbilical Cord-derived Mesenchymal Stromal Cells in Knee Osteoarthritis | Umbilical Cord | Chile | I/II | Kellgren-Lawrence classification grade 1–3 radiographic OA severity | Randomised, parallel assignment, double blind | 30 | 12 months | MSCs (single dose of 20 million MSCs or double dose at 6 month interval) vs. hyaluronic acid | Intra-articular injection | Safety | On-going (estimated study completion date; December 2016) | NCT02580695 |
Human Umbilical Cord Mesenchymal Stem Cell Transplantation in Articular Cartilage Defect | Umbilical Cord | China | I | Kellgren-Lawrence classification grade 2–4 radiographic OA severity | Single group assignment, open label | 20 | 12 months | 20 million cells every month for 4 months | Intra-articular injection | Safety | On-going (estimated study completion date; December 2016) | NCT02291926 |
Evaluation of Safety and Exploratory Efficacy of CARTISTEM®, a Cell Therapy Product for Articular Cartilage Defects | Umbilical cord blood | Korea | I/II | Focal, full-thickness grade 3–4 articular cartilage defects | Single group assignment, open label | 12 | 12 months | CARTISTEM® (cultured UC MSCs mixed with sodium hyaluronate) | Unknown | Safety | On-going (estimated study completion date; May 2017) | NCT01733186 |
Study to Compare the Efficacy and Safety of Cartistem® and Microfracture in Patients With Knee Articular Cartilage Injury or Defect | Umbilical cord blood | Korea | III | Knee Articular Cartilage Injury or Defect | Randomised, parallel assignment, open label | 104 | 48 weeks | CARTISTEM® (cultured UC MSCs mixed with sodium hyaluronate) vs. Microfracture | Surgery | CRS cartilage repair assessment | Completed in January 2011; no publication found | NCT01041001 |
Follow-Up Study of CARTISTEM® vs. Microfracture for the Treatment of Knee Articular Cartilage Injury or Defect | Umbilical cord blood | Korea | III | Knee articular cartilage injury or defect | Randomised, parallel assignment, open label | 103 | 60 months | CARTISTEM® (cultured UC MSCs mixed with sodium hyaluronate) vs. microfracture | Unknown | IKDC, VAS pain, WOMAC | On-going (estimated study completion date; May 2015) | NCT01626677 |
Injections of FloGraft Therapy, Autologous Stem Cells, or Platelet Rich Plasma for the Treatment of Degenerative Joint Pain | Amniotic fluid | USA | NA | Pain associated with one of the following conditions: lumbar facet degeneration, degenerative condition causing upper extremity joint pain or degenerative condition causing lower extremity joint pain | Cohort observational study | 300 | 24 weeks | FloGraftTM (allogenic amniotic fluid-derived allograft) vs. autologous BMMSCs vs. platelet rich plasma | Injection | Pain | On-going (estimated study completion date; June 2016) | NCT01978639 |
IMPACT: Safety and Feasibility of a Single-stage Procedure for Focal Cartilage Lesions of the Knee | Unspecified | The Netherlands | I/II | Full-thickness articular cartilage lesion on the femoral condyle or trochlea | Single-group assignment, open label | 35 | 18 months | Autologous chondrons (chondrocytes with their pericellular matrix) and allogeneic MSCs in the fibrin glue carrier | Unspecified (single stage surgery) | Safety | On-going (Estimated Study Completion Date: August 2015) | NCT02037204 |
Allogeneic Mesenchymal Stem Cells in Osteoarthritis | Unspecified | India | II | Kellgren and Lawrence classification grade 2–3 radiographic OA severity | Randomised, double blind, multi-centre | 60 | 2 years | Culture-expanded MSCs in 2 ml plasmalyte + 2 ml, hyaluronan vs. 2 ml, plasmalyte + 2 ml, hyaluronan | Intra-articular | Safety and tolerability | Unknown (estimated study completion date; July 2014 | NCT01453738 |
Allogeneic Mesenchymal Stem Cells for Osteoarthritis | Unspecified | Malaysia | II | Kellgren and Lawrence classification grade 2–3 OA | Randomised, double blind, multi-centre | 72 | 1 year | Culture-expanded MSCs in 2 ml plasmalyte + 2 ml, hyaluronan vs. 2 ml, plasmalyte + 2 ml, hyaluronan | Intra-articular | Safety and tolerability | Unknown (estimated study completion date; February 2013) | NCT01448434 |
Autologous or allogenic unspecified | ||||||||||||
Transplantation of Bone Marrow Derived Mesenchymal Stem Cells in Affected Knee Osteoarthritis by Rheumatoid Arthritis | Bone marrow | II/III | Iran | Rheumatoid arthritis | Randomised, parallel assignment, open label | 60 | 6 months | MSCs vs. saline | Intra-articular injection | Pain | Completed in December 2011; no publication found | NCT01873625 |
Safety and Efficacy Study of MSB-CAR001 in Subjects 6 Weeks Post an Anterior Cruciate Ligament Reconstruction | Unknown | I/II | Australia | Anterior cruciate ligament injury | Randomised, parallel assignment, double blind | 24 | 2 year | MSB-CAR001 (a preparation of MSCs) with hyaluronan vs. hyaluronan alone | Injection | Safety | Unknown | NCT01088191 |