The effect of intra‐articular injection of autologous bone marrow stem cells on pain and knee function in patients with osteoarthritis
Aim Management of osteoarthritis (OA) is basically symptomatic. Recently, stem cells (SC) have been used in the search for an optimum treatment. We decided to conduct a controlled clinical trial to determine if a single intra‐articular injection of in vivo stimulated bone marrow SC could lead to an...
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Published in | International journal of rheumatic diseases Vol. 21; no. 1; pp. 140 - 147 |
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Main Authors | , , , , , , , , , |
Format | Journal Article |
Language | English |
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England
Wiley Subscription Services, Inc
01.01.2018
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Abstract | Aim
Management of osteoarthritis (OA) is basically symptomatic. Recently, stem cells (SC) have been used in the search for an optimum treatment. We decided to conduct a controlled clinical trial to determine if a single intra‐articular injection of in vivo stimulated bone marrow SC could lead to an improvement in pain management and quality of life in patients with knee OA.
Method
This was a prospective, open‐label, phase I/II clinical trial to assess the safety and efficacy of a single intra‐articular injection of autologous stimulated bone marrow stem cells (BM‐SC) in patients with knee OA. Individuals of both genders older than 30 years with confirmed diagnosis of OA who signed informed consent were included in two groups: SC group received in vivo BM stimulation with subcutaneous administration of granulocyte colony stimulating factor (G‐CSF). SC were obtained by BM aspiration and administered in a single intra‐articular injection. The control group received exclusively oral acetaminophen. Visual analogue scale and Western Ontario and McMaster Universities Osteoarthritis Index scores were performed at 1 week, 1 month and 6 months in both groups. This trial was registered in ClinialTrials.gov NCT01485198.
Results
A total of 61 patients were included. Socio‐demographic characteristics, OA grades and initial scores were similar in both groups. The BM‐SC group showed significant improvement in knee pain and quality of life during the 6‐month follow‐up.
Conclusion
The study demonstrates feasibility and supports efficacy of a completely ambulatory procedure in treatment of knee OA. |
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AbstractList | AIMManagement of osteoarthritis (OA) is basically symptomatic. Recently, stem cells (SC) have been used in the search for an optimum treatment. We decided to conduct a controlled clinical trial to determine if a single intra-articular injection of in vivo stimulated bone marrow SC could lead to an improvement in pain management and quality of life in patients with knee OA.METHODThis was a prospective, open-label, phase I/II clinical trial to assess the safety and efficacy of a single intra-articular injection of autologous stimulated bone marrow stem cells (BM-SC) in patients with knee OA. Individuals of both genders older than 30 years with confirmed diagnosis of OA who signed informed consent were included in two groups: SC group received in vivo BM stimulation with subcutaneous administration of granulocyte colony stimulating factor (G-CSF). SC were obtained by BM aspiration and administered in a single intra-articular injection. The control group received exclusively oral acetaminophen. Visual analogue scale and Western Ontario and McMaster Universities Osteoarthritis Index scores were performed at 1 week, 1 month and 6 months in both groups. This trial was registered in ClinialTrials.gov NCT01485198.RESULTSA total of 61 patients were included. Socio-demographic characteristics, OA grades and initial scores were similar in both groups. The BM-SC group showed significant improvement in knee pain and quality of life during the 6-month follow-up.CONCLUSIONThe study demonstrates feasibility and supports efficacy of a completely ambulatory procedure in treatment of knee OA. Management of osteoarthritis (OA) is basically symptomatic. Recently, stem cells (SC) have been used in the search for an optimum treatment. We decided to conduct a controlled clinical trial to determine if a single intra-articular injection of in vivo stimulated bone marrow SC could lead to an improvement in pain management and quality of life in patients with knee OA. This was a prospective, open-label, phase I/II clinical trial to assess the safety and efficacy of a single intra-articular injection of autologous stimulated bone marrow stem cells (BM-SC) in patients with knee OA. Individuals of both genders older than 30 years with confirmed diagnosis of OA who signed informed consent were included in two groups: SC group received in vivo BM stimulation with subcutaneous administration of granulocyte colony stimulating factor (G-CSF). SC were obtained by BM aspiration and administered in a single intra-articular injection. The control group received exclusively oral acetaminophen. Visual analogue scale and Western Ontario and McMaster Universities Osteoarthritis Index scores were performed at 1 week, 1 month and 6 months in both groups. This trial was registered in ClinialTrials.gov NCT01485198. A total of 61 patients were included. Socio-demographic characteristics, OA grades and initial scores were similar in both groups. The BM-SC group showed significant improvement in knee pain and quality of life during the 6-month follow-up. The study demonstrates feasibility and supports efficacy of a completely ambulatory procedure in treatment of knee OA. Aim Management of osteoarthritis (OA) is basically symptomatic. Recently, stem cells (SC) have been used in the search for an optimum treatment. We decided to conduct a controlled clinical trial to determine if a single intra-articular injection of in vivo stimulated bone marrow SC could lead to an improvement in pain management and quality of life in patients with knee OA. Method This was a prospective, open-label, phase I/II clinical trial to assess the safety and efficacy of a single intra-articular injection of autologous stimulated bone marrow stem cells (BM-SC) in patients with knee OA. Individuals of both genders older than 30 years with confirmed diagnosis of OA who signed informed consent were included in two groups: SC group received in vivoBM stimulation with subcutaneous administration of granulocyte colony stimulating factor (G-CSF). SC were obtained by BM aspiration and administered in a single intra-articular injection. The control group received exclusively oral acetaminophen. Visual analogue scale and Western Ontario and McMaster Universities Osteoarthritis Index scores were performed at 1 week, 1 month and 6 months in both groups. This trial was registered in ClinialTrials.gov NCT01485198. Results A total of 61 patients were included. Socio-demographic characteristics, OA grades and initial scores were similar in both groups. The BM-SC group showed significant improvement in knee pain and quality of life during the 6-month follow-up. Conclusion The study demonstrates feasibility and supports efficacy of a completely ambulatory procedure in treatment of knee OA. Abstract Aim Management of osteoarthritis ( OA ) is basically symptomatic. Recently, stem cells ( SC ) have been used in the search for an optimum treatment. We decided to conduct a controlled clinical trial to determine if a single intra‐articular injection of in vivo stimulated bone marrow SC could lead to an improvement in pain management and quality of life in patients with knee OA . Method This was a prospective, open‐label, phase I/ II clinical trial to assess the safety and efficacy of a single intra‐articular injection of autologous stimulated bone marrow stem cells ( BM ‐ SC ) in patients with knee OA . Individuals of both genders older than 30 years with confirmed diagnosis of OA who signed informed consent were included in two groups: SC group received in vivo BM stimulation with subcutaneous administration of granulocyte colony stimulating factor (G‐ CSF ). SC were obtained by BM aspiration and administered in a single intra‐articular injection. The control group received exclusively oral acetaminophen. Visual analogue scale and Western Ontario and McMaster Universities Osteoarthritis Index scores were performed at 1 week, 1 month and 6 months in both groups. This trial was registered in ClinialTrials.gov NCT 01485198. Results A total of 61 patients were included. Socio‐demographic characteristics, OA grades and initial scores were similar in both groups. The BM ‐ SC group showed significant improvement in knee pain and quality of life during the 6‐month follow‐up. Conclusion The study demonstrates feasibility and supports efficacy of a completely ambulatory procedure in treatment of knee OA . Aim Management of osteoarthritis (OA) is basically symptomatic. Recently, stem cells (SC) have been used in the search for an optimum treatment. We decided to conduct a controlled clinical trial to determine if a single intra‐articular injection of in vivo stimulated bone marrow SC could lead to an improvement in pain management and quality of life in patients with knee OA. Method This was a prospective, open‐label, phase I/II clinical trial to assess the safety and efficacy of a single intra‐articular injection of autologous stimulated bone marrow stem cells (BM‐SC) in patients with knee OA. Individuals of both genders older than 30 years with confirmed diagnosis of OA who signed informed consent were included in two groups: SC group received in vivo BM stimulation with subcutaneous administration of granulocyte colony stimulating factor (G‐CSF). SC were obtained by BM aspiration and administered in a single intra‐articular injection. The control group received exclusively oral acetaminophen. Visual analogue scale and Western Ontario and McMaster Universities Osteoarthritis Index scores were performed at 1 week, 1 month and 6 months in both groups. This trial was registered in ClinialTrials.gov NCT01485198. Results A total of 61 patients were included. Socio‐demographic characteristics, OA grades and initial scores were similar in both groups. The BM‐SC group showed significant improvement in knee pain and quality of life during the 6‐month follow‐up. Conclusion The study demonstrates feasibility and supports efficacy of a completely ambulatory procedure in treatment of knee OA. |
Author | Villarreal‐Martínez, Laura Vilchez‐Cavazos, Felix Diaz‐Hutchinson, Cesar Jaime‐Pérez, José C. Pérez‐Garza, Daniela M. Gómez‐Almaguer, David Garay‐Mendoza, Domingo Mancías‐Guerra, Consuelo Garza‐Bedolla, Alejandra Acosta‐Olivo, Carlos |
Author_xml | – sequence: 1 givenname: Domingo surname: Garay‐Mendoza fullname: Garay‐Mendoza, Domingo organization: Universidad Autónoma de Nuevo León – sequence: 2 givenname: Laura orcidid: 0000-0003-0313-7312 surname: Villarreal‐Martínez fullname: Villarreal‐Martínez, Laura email: dr_lauravillarreal@hotmail.com organization: Universidad Autónoma de Nuevo León – sequence: 3 givenname: Alejandra surname: Garza‐Bedolla fullname: Garza‐Bedolla, Alejandra organization: Universidad Autónoma de Nuevo León – sequence: 4 givenname: Daniela M. surname: Pérez‐Garza fullname: Pérez‐Garza, Daniela M. organization: Universidad Autónoma de Nuevo León – sequence: 5 givenname: Carlos surname: Acosta‐Olivo fullname: Acosta‐Olivo, Carlos organization: Universidad Autónoma de Nuevo León – sequence: 6 givenname: Felix surname: Vilchez‐Cavazos fullname: Vilchez‐Cavazos, Felix organization: Universidad Autónoma de Nuevo León – sequence: 7 givenname: Cesar surname: Diaz‐Hutchinson fullname: Diaz‐Hutchinson, Cesar organization: Universidad Autónoma de Nuevo León – sequence: 8 givenname: David surname: Gómez‐Almaguer fullname: Gómez‐Almaguer, David organization: Universidad Autónoma de Nuevo León – sequence: 9 givenname: José C. surname: Jaime‐Pérez fullname: Jaime‐Pérez, José C. organization: Universidad Autónoma de Nuevo León – sequence: 10 givenname: Consuelo surname: Mancías‐Guerra fullname: Mancías‐Guerra, Consuelo organization: Universidad Autónoma de Nuevo León |
BackLink | https://www.ncbi.nlm.nih.gov/pubmed/28752679$$D View this record in MEDLINE/PubMed |
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Copyright | 2017 Asia Pacific League of Associations for Rheumatology and John Wiley & Sons Australia, Ltd 2017 Asia Pacific League of Associations for Rheumatology and John Wiley & Sons Australia, Ltd. International Journal of Rheumatic Diseases © 2018 Asia Pacific League of Associations for Rheumatology and John Wiley & Sons Australia, Ltd |
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Management of osteoarthritis (OA) is basically symptomatic. Recently, stem cells (SC) have been used in the search for an optimum treatment. We decided to... Management of osteoarthritis (OA) is basically symptomatic. Recently, stem cells (SC) have been used in the search for an optimum treatment. We decided to... Abstract Aim Management of osteoarthritis ( OA ) is basically symptomatic. Recently, stem cells ( SC ) have been used in the search for an optimum treatment.... Aim Management of osteoarthritis (OA) is basically symptomatic. Recently, stem cells (SC) have been used in the search for an optimum treatment. We decided to... AIMManagement of osteoarthritis (OA) is basically symptomatic. Recently, stem cells (SC) have been used in the search for an optimum treatment. We decided to... |
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SubjectTerms | Acetaminophen Arthritis Autografts Bone marrow Clinical trials Colony-stimulating factor Feasibility studies Granulocyte colony-stimulating factor Injection Knee knee osteoarthritis Leukocytes (granulocytic) Osteoarthritis Pain Quality of life Stem cells |
Title | The effect of intra‐articular injection of autologous bone marrow stem cells on pain and knee function in patients with osteoarthritis |
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