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Primary:
To study the safety of a single injection of autologous adipose derived mesenchymal stromal cells (ASCs) on patients with moderate or severe osteoarthritis of the knee (OA).
Secondary:
To study the efficacy of a single injection of autologous adipose derived mesenchymal stromal cells on patients with moderate or severe osteoarthritis of the knee (OA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | 2 x 10E6 ASC intra-articular injection (5 ml) |
|
| Group 2 | Experimental | 10 x 10E6 ASC intra-articular injection (5 ml) |
|
| Group 3 | Experimental | 50 x 10E6 ASC intra-articular injection (5 ml) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous adipose derived stem cells administrated for intra-articular use | Biological | Each patient will receive one single administration of the cells and will be followed for 3 months. Each patients will be follow-up during one year with routinely examinations for safety issues. |
| Measure | Description | Time Frame |
|---|---|---|
| Recording of Serious Adverse Events | Adverse events will be described with respect to seriousness, intensity, relationship to treatment, action taken and outcome of the adverse event. | during 365 days following injection |
| Measure | Description | Time Frame |
|---|---|---|
| Functional status of the knee | Efficacy will be assessed by measuring:
| during 365 days following injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Jorgensen, MD | University Hospital, Montpellier | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UH Montpellier | Montpellier | 34295 | France | |||
| Orthopädische Klinik |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27217345 | Derived | Pers YM, Rackwitz L, Ferreira R, Pullig O, Delfour C, Barry F, Sensebe L, Casteilla L, Fleury S, Bourin P, Noel D, Canovas F, Cyteval C, Lisignoli G, Schrauth J, Haddad D, Domergue S, Noeth U, Jorgensen C; ADIPOA Consortium. Adipose Mesenchymal Stromal Cell-Based Therapy for Severe Osteoarthritis of the Knee: A Phase I Dose-Escalation Trial. Stem Cells Transl Med. 2016 Jul;5(7):847-56. doi: 10.5966/sctm.2015-0245. Epub 2016 May 23. |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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|
| Autologous adipose derived stem cells administrated for intra-articular use | Biological | Each patient will receive one single administration of the cells and will be followed for 3 months. Each patients will be follow-up during one year with routinely examinations for safety issues. The first patient will be followed during 12 weeks before inclusion of the second patient. |
|
| Evaluation of Quality of life |
Quality of life will be assessed by measuring:
|
| during 365 days following injection |
| Würzburg |
| 97074 |
| Germany |