Not provided
Not provided
Not provided
Not provided
Not provided
Recruitment was suspended due to the COVID pandemic and it was decided not to resume the study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to study the clinical outcomes and effects of the injection of fat-derived stem cells (the scientific name being "adipose derived autologous stem cell transplantation (ADAT)") as an addition to knee arthroscopy in the treatment of knee swelling and pain associated with mild to moderate knee osteoarthritis. Management of this condition remains a pervasive problem within orthopaedics. Lipogems is a Food and Drug Administration (FDA) approved technique. Lipogems is the name of the technology used to obtain stem cells from fat that will be aspirated/removed by suction from the abdomen. Fat will be processed to obtain stem cells which will then be injected into the knee after the physician completes knee arthroscopy. The study that we are asking patients to enroll in is important because it will attempt to answer the question about whether fat-derived stem cells added to knee arthroscopy is better, worse or no different than knee arthroscopy alone. Currently, without this study, we do not have an answer to this question.
Protocol Outline:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Knee Arthroscopy + Adipose Derived Stem Cells (ADSC) | Experimental | Experimental Group: will undergo diagnostic knee arthroscopy with injection of adipose derived stem cells. Will also carry out all procedures associated with study (Physical Exam, Magnetic Resonance Imaging (MRIs), X-rays, Questionnaires). |
|
| Observation Cohort: Knee Arthroscopy | Other | Observational Group: will undergo diagnostic knee arthroscopy (No injection of adipose derived stem cells). Will also carry out all procedures associated with study (Physical Exam, MRIs, X-rays, Questionnaires). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lipogems Device PLUS debridement | Device | Lipogems is the name of the technology used to obtain stem cells from the abdomen, which will then be injected into the knee after knee arthroscopy. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Knee Injury and Osteoarthritis Outcome (KOOS) Pain Subscale | Questions related to knee pain Scale range: 0-100 points (100 indicating no symptoms and 0 indicating extreme symptoms) | Baseline, 2-Week post-op, 6-Week post-op |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Knee Injury and Osteoarthritis Outcome (KOOS) Symptoms | Questions related to other knee symptoms other than pain Scale range: 0-100 points (100 indicating no symptoms and 0 indicating extreme symptoms) | Baseline, 2-Week post-op, 6-Week post-op |
| Change in Knee Injury and Osteoarthritis Outcome (KOOS) Function in Daily Living (ADL) |
Not provided
Inclusion Criteria:
Exclusion Criteria: The patients listed below are excluded due to potential confound factors which may alter clinical outcomes in either treatment group (1,3,4,5 7,8, 11, 12,13), if they may potentially cause a ceiling or floor effect to our clinical outcomes (2,6,) or if the treatment may constitute and undue risk to the patient or be outside of the standard of practice of treatment for that patient (1, 9, 10,14, 15, 16)
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Riley Williams, MD | Hospital for Special Surgery, New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery | New York | New York | 10021 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26253098 | Background | Atukorala I, Kwoh CK, Guermazi A, Roemer F, Boudreau R, Hannon MJ, Hunter DJ. Response to: 'Synovitis in knee osteoarthritis: a precursor or concomitant feature?' by Zeng et al. Ann Rheum Dis. 2015 Oct;74(10):e59. doi: 10.1136/annrheumdis-2015-207800. Epub 2015 Aug 7. No abstract available. | |
| 27547374 | Background |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Knee Arthroscopy + Adipose Derived Stem Cells (ADSC) | Experimental Group: will undergo diagnostic knee arthroscopy with injection of adipose derived stem cells. Will also carry out all procedures associated with study (Physical Exam, Magnetic Resonance Imaging (MRIs), X-rays, Questionnaires). Lipogems Device PLUS debridement: Lipogems is the name of the technology used to obtain stem cells from the abdomen, which will then be injected into the knee after knee arthroscopy. |
| FG001 | Observation Cohort: Knee Arthroscopy | Observational Group: will undergo diagnostic knee arthroscopy (No injection of adipose derived stem cells). Will also carry out all procedures associated with study (Physical Exam, MRIs, X-rays, Questionnaires). Debridement only: Patients will undergo knee arthroscopy as a standard treatment for their condition but will not receive the fat-derived stem cell treatment nor will undergo any additional procedures. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Due to COVID, recruiting patients was difficult and thus the study has been suspended. To add to that difficulty, RAs have not been permanent and have been leaving prior the agreed time when hired. The target number of participants was never obtained and thus the data set is incomplete.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Knee Arthroscopy + Adipose Derived Stem Cells (ADSC) | Experimental Group: will undergo diagnostic knee arthroscopy with injection of adipose derived stem cells. Will also carry out all procedures associated with study (Physical Exam, Magnetic Resonance Imaging (MRIs), X-rays, Questionnaires). Lipogems Device PLUS debridement: Lipogems is the name of the technology used to obtain stem cells from the abdomen, which will then be injected into the knee after knee arthroscopy. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Due to COVID, recruiting patients was difficult and thus the study has been suspended. To add to that difficulty, RAs have not been permanent and have been leaving prior the agreed time when hired. The target number of participants was never obtained and thus the data set is incomplete. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Knee Injury and Osteoarthritis Outcome (KOOS) Pain Subscale | Questions related to knee pain Scale range: 0-100 points (100 indicating no symptoms and 0 indicating extreme symptoms) | Due to COVID, recruiting patients was difficult and thus the study has been suspended. To add to that difficulty, RAs have not been permanent and have been leaving prior the agreed time when hired. The target number of participants was never obtained and thus the data set is incomplete. | Posted | Mean | Full Range | score on a scale | Baseline, 2-Week post-op, 6-Week post-op |
|
Up to 1 year post-op, adverse event data was collected for each patient.
Due to COVID, recruiting patients was difficult and thus the study has been suspended. To add to that difficulty, RAs have not been permanent and have been leaving prior the agreed time when hired. The target number of participants was never obtained and thus the data set is incomplete.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Knee Arthroscopy + Adipose Derived Stem Cells (ADSC) | Experimental Group: will undergo diagnostic knee arthroscopy with injection of adipose derived stem cells. Will also carry out all procedures associated with study (Physical Exam, Magnetic Resonance Imaging (MRIs), X-rays, Questionnaires). Lipogems Device PLUS debridement: Lipogems is the name of the technology used to obtain stem cells from the abdomen, which will then be injected into the knee after knee arthroscopy. |
Not provided
Not provided
Due to COVID, recruiting patients has been difficult. To add to that difficulty, RAs have not been permanent and have been leaving prior the agreed time when hired. Even though Dr. Williams prescreens patients himself for this study, without an RA it has made things much more difficult. At the moment we are in the hiring process and hope this changes for the next continuing review. There have been no changes since the last time.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessica Rios | Hospital for Special Surgery | 212-774-7321 | riosj@hss.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 16, 2022 | Nov 2, 2022 | Prot_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 11, 2018 | Nov 2, 2022 | ICF_003.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D003646 | Debridement |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Debridement only | Procedure | Patients will undergo knee arthroscopy as a standard treatment for their condition but will not receive the fat-derived stem cell treatment nor will undergo any additional procedures. |
|
Questions related to function in daily living Scale range: 0-100 points (100 indicating no symptoms and 0 indicating extreme symptoms) |
| Baseline, 2-Week post-op, 6-Week post-op |
| Change in Knee Injury and Osteoarthritis Outcome (KOOS) Function in Sport and Recreation (Sport/Rec) | Questions related to function in sport and recreation Scale range: 0-100 points (100 indicating no symptoms and 0 indicating extreme symptoms) | Baseline, 2-Week post-op, 6-Week post-op |
| Change in Knee Injury and Osteoarthritis Outcome (KOOS) Quality of Life (QOL) | Questions related to knee-related quality of life Scale range: 0-100 points (100 indicating no symptoms and 0 indicating extreme symptoms) | Baseline, 2-Week post-op, 6-Week post-op |
| Change in International Knee Documentation Committee (IKDC) Subjective Knee Form | Questions related to knee function over periods of time (100 indicating no symptoms and 0 indicating extreme symptoms) | Baseline, 2-Week post-op, 6-Week post-op |
| Change in Numerical Pain Rating Scale (NPRS) | Numerical pain rating scale for pain in knee (0-10) (0: no pain - 10: worst pain imaginable) | Baseline, 2-Week post-op, 6-Week post-op |
| Change in Marx Activity Rating Scale | Measures frequency of activity in healthiest and most active state during past year Includes four knee functions, each rated 0-4 total scale range 0-16 (higher score indicates more frequent participation/activity) | Baseline, 2-Week post-op, 6-Week post-op |
| Change in Patient-Reported Outcomes Measurement Information System Global-10 Short Form (PROMIS-10) | 10-item questionnaire with nine 5-point (as well as a single 11-point) rating scales. The results are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. These scores are then standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient. 11-point scale question recalculated to a 5 point scale. only 8 of 10 questions used for scoring calculations (Each sub-score is generated by 4/8 questions) - 4Qs, 5 points each Scale from 0-20 to calculate Global Mental Health Raw Score (higher score means better outcome) Scale from 0-20 to calculate Global Physical Health Raw Score (higher score means better outcome) The raw scores are then standardized to general population using the "T-score": Global physical health t-score range: 16.2-67.7 Global mental health t-score range: 21.2-67.6 | Baseline, 2-Week post-op, 6-Week post-op |
| Ceserani V, Ferri A, Berenzi A, Benetti A, Ciusani E, Pascucci L, Bazzucchi C, Cocce V, Bonomi A, Pessina A, Ghezzi E, Zeira O, Ceccarelli P, Versari S, Tremolada C, Alessandri G. Angiogenic and anti-inflammatory properties of micro-fragmented fat tissue and its derived mesenchymal stromal cells. Vasc Cell. 2016 Aug 18;8:3. doi: 10.1186/s13221-016-0037-3. eCollection 2016. |
| 28066501 | Background | Fellows CR, Matta C, Zakany R, Khan IM, Mobasheri A. Adipose, Bone Marrow and Synovial Joint-Derived Mesenchymal Stem Cells for Cartilage Repair. Front Genet. 2016 Dec 20;7:213. doi: 10.3389/fgene.2016.00213. eCollection 2016. |
| 28589877 | Background | Jannelli E, Fontana A. Arthroscopic treatment of chondral defects in the hip: AMIC, MACI, microfragmented adipose tissue transplantation (MATT) and other options. SICOT J. 2017;3:43. doi: 10.1051/sicotj/2017029. Epub 2017 Jun 7. |
| 30128683 | Background | Karpinski K, Muller-Rath R, Niemeyer P, Angele P, Petersen W. Subgroups of patients with osteoarthritis and medial meniscus tear or crystal arthropathy benefit from arthroscopic treatment. Knee Surg Sports Traumatol Arthrosc. 2019 Mar;27(3):782-796. doi: 10.1007/s00167-018-5086-0. Epub 2018 Aug 20. |
| 26585585 | Background | Koh YG, Kwon OR, Kim YS, Choi YJ, Tak DH. Adipose-Derived Mesenchymal Stem Cells With Microfracture Versus Microfracture Alone: 2-Year Follow-up of a Prospective Randomized Trial. Arthroscopy. 2016 Jan;32(1):97-109. doi: 10.1016/j.arthro.2015.09.010. Epub 2015 Nov 14. |
| 24326779 | Background | Koh YG, Choi YJ, Kwon SK, Kim YS, Yeo JE. Clinical results and second-look arthroscopic findings after treatment with adipose-derived stem cells for knee osteoarthritis. Knee Surg Sports Traumatol Arthrosc. 2015 May;23(5):1308-1316. doi: 10.1007/s00167-013-2807-2. Epub 2013 Dec 11. |
| 30133187 | Background | MacFarlane LA, Yang H, Collins JE, Jarraya M, Guermazi A, Mandl LA, Martin SD, Wright J, Losina E, Katz JN; MeTeOR Investigator Group. Association of Changes in Effusion-Synovitis With Progression of Cartilage Damage Over Eighteen Months in Patients With Osteoarthritis and Meniscal Tear. Arthritis Rheumatol. 2019 Jan;71(1):73-81. doi: 10.1002/art.40660. Epub 2018 Nov 29. |
| 21542697 | Background | Marchal JA, Picon M, Peran M, Bueno C, Jimenez-Navarro M, Carrillo E, Boulaiz H, Rodriguez N, Alvarez P, Menendez P, de Teresa E, Aranega A. Purification and long-term expansion of multipotent endothelial-like cells with potential cardiovascular regeneration. Stem Cells Dev. 2012 Mar 1;21(4):562-74. doi: 10.1089/scd.2011.0072. Epub 2011 Jun 17. |
| 27057170 | Background | Randelli P, Menon A, Ragone V, Creo P, Bergante S, Randelli F, De Girolamo L, Alfieri Montrasio U, Banfi G, Cabitza P, Tettamanti G, Anastasia L. Lipogems Product Treatment Increases the Proliferation Rate of Human Tendon Stem Cells without Affecting Their Stemness and Differentiation Capability. Stem Cells Int. 2016;2016:4373410. doi: 10.1155/2016/4373410. Epub 2016 Jan 6. |
| 30280218 | Background | Schiavone Panni A, Vasso M, Braile A, Toro G, De Cicco A, Viggiano D, Lepore F. Preliminary results of autologous adipose-derived stem cells in early knee osteoarthritis: identification of a subpopulation with greater response. Int Orthop. 2019 Jan;43(1):7-13. doi: 10.1007/s00264-018-4182-6. Epub 2018 Oct 3. |
| Background | Striano R. D., Chen H., Bilbool N., Azatullah K., Hilado J., Horan K. Case Study: Non-Responsive Knee Pain with Osteoarthritis and Concurrent Meniscal Disease Treated With Autologous Micro-Fragmented Adipose Tissue Under Continuous Ultrasound Guidance CellR4 2015; 3 (5): e1690 |
| Background | Tremolada, Carlo. (2017). Mesenchymal Stem Cells and Regenerative Medicine: How Lipogems Technology Make Them Easy, Safe and More Effective to Use. MOJ Biology and Medicine. 2. 10.15406/mojbm.2017.02.00047. |
| 27236668 | Background | Tremolada C, Ricordi C, Caplan AI, Ventura C. Mesenchymal Stem Cells in Lipogems, a Reverse Story: from Clinical Practice to Basic Science. Methods Mol Biol. 2016;1416:109-22. doi: 10.1007/978-1-4939-3584-0_6. |
| 26568597 | Background | Wang X, Jin X, Han W, Cao Y, Halliday A, Blizzard L, Pan F, Antony B, Cicuttini F, Jones G, Ding C. Cross-sectional and Longitudinal Associations between Knee Joint Effusion Synovitis and Knee Pain in Older Adults. J Rheumatol. 2016 Jan;43(1):121-30. doi: 10.3899/jrheum.150355. Epub 2015 Nov 15. |
| BG001 | Observation Cohort: Knee Arthroscopy | Observational Group: will undergo diagnostic knee arthroscopy (No injection of adipose derived stem cells). Will also carry out all procedures associated with study (Physical Exam, MRIs, X-rays, Questionnaires). Debridement only: Patients will undergo knee arthroscopy as a standard treatment for their condition but will not receive the fat-derived stem cell treatment nor will undergo any additional procedures. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | Due to COVID, recruiting patients was difficult and thus the study has been suspended. To add to that difficulty, RAs have not been permanent and have been leaving prior the agreed time when hired. The target number of participants was never obtained and thus the data set is incomplete. | Mean | Full Range | years |
|
| Sex: Female, Male | Due to COVID, recruiting patients was difficult and thus the study has been suspended. To add to that difficulty, RAs have not been permanent and have been leaving prior the agreed time when hired. The target number of participants was never obtained and thus the data set is incomplete. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Due to COVID, recruiting patients was difficult and thus the study has been suspended. To add to that difficulty, RAs have not been permanent and have been leaving prior the agreed time when hired. The target number of participants was never obtained and thus the data set is incomplete. | Count of Participants | Participants |
|
| Region of Enrollment | Due to COVID, recruiting patients was difficult and thus the study has been suspended. To add to that difficulty, RAs have not been permanent and have been leaving prior the agreed time when hired. The target number of participants was never obtained and thus the data set is incomplete. | Number | participants |
|
| OG001 | Observation Cohort: Knee Arthroscopy | Observational Group: will undergo diagnostic knee arthroscopy (No injection of adipose derived stem cells). Will also carry out all procedures associated with study (Physical Exam, MRIs, X-rays, Questionnaires). Debridement only: Patients will undergo knee arthroscopy as a standard treatment for their condition but will not receive the fat-derived stem cell treatment nor will undergo any additional procedures. |
|
|
| Secondary | Change in Knee Injury and Osteoarthritis Outcome (KOOS) Symptoms | Questions related to other knee symptoms other than pain Scale range: 0-100 points (100 indicating no symptoms and 0 indicating extreme symptoms) | Due to COVID, recruiting patients was difficult and thus the study has been suspended. To add to that difficulty, RAs have not been permanent and have been leaving prior the agreed time when hired. The target number of participants was never obtained and thus the data set is incomplete. | Posted | Mean | Full Range | score on a scale | Baseline, 2-Week post-op, 6-Week post-op |
|
|
|
| Secondary | Change in Knee Injury and Osteoarthritis Outcome (KOOS) Function in Daily Living (ADL) | Questions related to function in daily living Scale range: 0-100 points (100 indicating no symptoms and 0 indicating extreme symptoms) | Due to COVID, recruiting patients was difficult and thus the study has been suspended. To add to that difficulty, RAs have not been permanent and have been leaving prior the agreed time when hired. The target number of participants was never obtained and thus the data set is incomplete. | Posted | Mean | Full Range | score on a scale | Baseline, 2-Week post-op, 6-Week post-op |
|
|
|
| Secondary | Change in Knee Injury and Osteoarthritis Outcome (KOOS) Function in Sport and Recreation (Sport/Rec) | Questions related to function in sport and recreation Scale range: 0-100 points (100 indicating no symptoms and 0 indicating extreme symptoms) | Due to COVID, recruiting patients was difficult and thus the study has been suspended. To add to that difficulty, RAs have not been permanent and have been leaving prior the agreed time when hired. The target number of participants was never obtained and thus the data set is incomplete. | Posted | Mean | Full Range | score on a scale | Baseline, 2-Week post-op, 6-Week post-op |
|
|
|
| Secondary | Change in Knee Injury and Osteoarthritis Outcome (KOOS) Quality of Life (QOL) | Questions related to knee-related quality of life Scale range: 0-100 points (100 indicating no symptoms and 0 indicating extreme symptoms) | Due to COVID, recruiting patients was difficult and thus the study has been suspended. To add to that difficulty, RAs have not been permanent and have been leaving prior the agreed time when hired. The target number of participants was never obtained and thus the data set is incomplete. | Posted | Mean | Full Range | score on a scale | Baseline, 2-Week post-op, 6-Week post-op |
|
|
|
| Secondary | Change in International Knee Documentation Committee (IKDC) Subjective Knee Form | Questions related to knee function over periods of time (100 indicating no symptoms and 0 indicating extreme symptoms) | Due to COVID, recruiting patients was difficult and thus the study has been suspended. To add to that difficulty, RAs have not been permanent and have been leaving prior the agreed time when hired. The target number of participants was never obtained and thus the data set is incomplete. | Posted | Mean | Full Range | units on a scale | Baseline, 2-Week post-op, 6-Week post-op |
|
|
|
| Secondary | Change in Numerical Pain Rating Scale (NPRS) | Numerical pain rating scale for pain in knee (0-10) (0: no pain - 10: worst pain imaginable) | Due to COVID, recruiting patients was difficult and thus the study has been suspended. To add to that difficulty, RAs have not been permanent and have been leaving prior the agreed time when hired. The target number of participants was never obtained and thus the data set is incomplete. | Posted | Mean | Full Range | score on a scale | Baseline, 2-Week post-op, 6-Week post-op |
|
|
|
| Secondary | Change in Marx Activity Rating Scale | Measures frequency of activity in healthiest and most active state during past year Includes four knee functions, each rated 0-4 total scale range 0-16 (higher score indicates more frequent participation/activity) | Due to COVID, recruiting patients was difficult and thus the study has been suspended. To add to that difficulty, RAs have not been permanent and have been leaving prior the agreed time when hired. The target number of participants was never obtained and thus the data set is incomplete. | Posted | Mean | Full Range | score on a scale | Baseline, 2-Week post-op, 6-Week post-op |
|
|
|
| Secondary | Change in Patient-Reported Outcomes Measurement Information System Global-10 Short Form (PROMIS-10) | 10-item questionnaire with nine 5-point (as well as a single 11-point) rating scales. The results are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. These scores are then standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient. 11-point scale question recalculated to a 5 point scale. only 8 of 10 questions used for scoring calculations (Each sub-score is generated by 4/8 questions) - 4Qs, 5 points each Scale from 0-20 to calculate Global Mental Health Raw Score (higher score means better outcome) Scale from 0-20 to calculate Global Physical Health Raw Score (higher score means better outcome) The raw scores are then standardized to general population using the "T-score": Global physical health t-score range: 16.2-67.7 Global mental health t-score range: 21.2-67.6 | Due to COVID, recruiting patients was difficult and thus the study has been suspended. To add to that difficulty, RAs have not been permanent and have been leaving prior the agreed time when hired. The target number of participants was never obtained and thus the data set is incomplete. | Posted | Mean | Full Range | T-score | Baseline, 2-Week post-op, 6-Week post-op |
|
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | Observation Cohort: Knee Arthroscopy | Observational Group: will undergo diagnostic knee arthroscopy (No injection of adipose derived stem cells). Will also carry out all procedures associated with study (Physical Exam, MRIs, X-rays, Questionnaires). Debridement only: Patients will undergo knee arthroscopy as a standard treatment for their condition but will not receive the fat-derived stem cell treatment nor will undergo any additional procedures. | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
| D012216 |
| Rheumatic Diseases |
| 2-Week Post-op |
|
|
| 6-Week Post-op |
|
|
| 2-Week Post-op |
|
|
| 6-Week Post-op |
|
|
| 2-week Post-Op |
|
|
| 6-Week Post-Op |
|
|
| 2-Week Post-op |
|
|
| 6-Week Post-op |
|
|
| 2-Week Post-op |
|
|
| 6-Week Post-op |
|
|
| 2-Week Post-op |
|
|
| 6-Week Post-op |
|
|
| 2-Week Post-op |
|
|
| 6-Week Post-op |
|
|
| Baseline (Global Mental Health Score) |
|
|
| 2-Week Post-op (Global Physical Health Score) |
|
|
| 2-Week Post-op (Global Mental Health Score) |
|
|
| 6-Week Post-op (Global Physical Health Score) |
|
|
| 6-Week Post-Op (Global Mental Health Score) |
|
|