Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Patients with osteoarthritis, a degenerative joint disease, that meet inclusion criteria will be allocated into two groups:
Signed informed consent is required, as well as answering a questionnaire.
Patients in experimental group will receive subcutaneous G-CSF (10ug/kg/day) for 3 consecutive days and, on the 4th day a bone marrow harvest under general sedation will be performed from posterior iliac crests. The patient will remain in the recovery room while the cells are processed at the Hematology Service Laboratory. Finally, BMASC will be infused to the joint under local anesthesia.
The procedure is ambulatory.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Patients treated with Acetaminophen |
|
| Experimental | Experimental | Patients who underwent a BMASC extraction and joint infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bone Marrow Autologous Stem Cells Infusion | Procedure | Extraction and knee infusion of Bone Marrow Autologous Stem Cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Define safety of BM extraction and stem cell joint infusion. | Measure possible complications of procedure (e.g. pain, bleeding, infection) and range of motion through clinical examination. Apply a questionnaire consisting of validated Womac® Scale, KSS® (Knee Society Rating System), SF-36® (Health Survey Update), and VAS (Visual Analog Scale) to correlate changes at first week to the baseline questionnaire. | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of BMSC joint infusion at 4 weeks | Measure possible complications of procedure (e.g. pain, bleeding, infection) and range of motion through clinical examination. Apply a questionnaire consisting of validated Womac® Scale, KSS® (Knee Society Rating System), SF-36® (Health Survey Update), and VAS (Visual Analog Scale) to correlate changes with first week and baseline questionnaires. | 4 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Domingo Garay Mendoza, MD | Hospital Universitario Dr. Jose E. Gonzalez | Principal Investigator |
| Consuelo Mancias Guerra, MD | Hospital Universitario Dr. Jose E. Gonzalez | Study Director |
| Laura Villarreal Martínez, MD | Hospital Universitario Dr. Jose E. Gonzalez | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hematology Service | Monerrey | Nuevo León | 64460 | Mexico | ||
| Traumatology Service |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21518322 | Result | Davatchi F, Abdollahi BS, Mohyeddin M, Shahram F, Nikbin B. Mesenchymal stem cell therapy for knee osteoarthritis. Preliminary report of four patients. Int J Rheum Dis. 2011 May;14(2):211-5. doi: 10.1111/j.1756-185X.2011.01599.x. Epub 2011 Mar 4. | |
| 20934693 | Result | de Girolamo L, Bertolini G, Cervellin M, Sozzi G, Volpi P. Treatment of chondral defects of the knee with one step matrix-assisted technique enhanced by autologous concentrated bone marrow: in vitro characterisation of mesenchymal stem cells from iliac crest and subchondral bone. Injury. 2010 Nov;41(11):1172-7. doi: 10.1016/j.injury.2010.09.027. Epub 2010 Oct 8. |
| Label | URL |
|---|---|
| Traumatology Service Web Site | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D000894 | Anti-Inflammatory Agents, Non-Steroidal |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Acetaminophen | Drug | Acetaminophen (750mg orally TID) administration |
|
|
| Efficacy and final outcome of BMSC joint infusion at 6 months. | Measure possible complications of procedure (e.g. pain, bleeding, infection) and range of motion through clinical examination. Apply a questionnaire consisting of validated Womac® Scale, KSS® (Knee Society Rating System), SF-36® (Health Survey Update), and VAS (Visual Analog Scale) to correlate changes with 4 week, first week and baseline questionnaires. | 24 weeks |
| Monterrey |
| Nuevo León |
| 64460 |
| Mexico |
| 21300401 | Result | Chen FM, Wu LA, Zhang M, Zhang R, Sun HH. Homing of endogenous stem/progenitor cells for in situ tissue regeneration: Promises, strategies, and translational perspectives. Biomaterials. 2011 Apr;32(12):3189-209. doi: 10.1016/j.biomaterials.2010.12.032. |
| 28752679 | Derived | Garay-Mendoza D, Villarreal-Martinez L, Garza-Bedolla A, Perez-Garza DM, Acosta-Olivo C, Vilchez-Cavazos F, Diaz-Hutchinson C, Gomez-Almaguer D, Jaime-Perez JC, Mancias-Guerra C. The effect of intra-articular injection of autologous bone marrow stem cells on pain and knee function in patients with osteoarthritis. Int J Rheum Dis. 2018 Jan;21(1):140-147. doi: 10.1111/1756-185X.13139. Epub 2017 Jul 27. |
| Aniline Compounds |
| D000588 | Amines |
| D018712 | Analgesics, Non-Narcotic |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000893 | Anti-Inflammatory Agents |
| D045506 | Therapeutic Uses |
| D018501 | Antirheumatic Agents |