The Comparison of Efficacy and Safety of the Mesenchymal Stem Cells From Adipose and Hyaluronic Acid
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|ClinicalTrials.gov Identifier: NCT03357575|
Recruitment Status : Not yet recruiting
First Posted : November 30, 2017
Last Update Posted : November 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Knee Osteoarthritis||Biological: Mesenchymal Stem Cells from adipose Biological: Hyaluronic Acid||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||14 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Comparison of Efficacy and Safety of the Mesenchymal Stem Cells From Adipose and Hyaluronic Acid in the Treatment of Adult Knee Osteoarthritis|
|Estimated Study Start Date :||January 1, 2018|
|Estimated Primary Completion Date :||June 1, 2020|
|Estimated Study Completion Date :||December 1, 2020|
Experimental: Mesenchymal Stem Cells from adipose
Mesenchymal Stem Cells from adipose will be injected.
Biological: Mesenchymal Stem Cells from adipose
inject mesenchymal Stem Cells from adipose
Active Comparator: hyaluronic acid
Hyaluronic acid will be injectied.
Biological: Hyaluronic Acid
inject hyaluronic acid
- Unexplained local and systemic symptoms or death [ Time Frame: 2 years ]The severity of AE must be recorded and graded according to the CTCAE criteria, and its relationship to therapy must be assessed according to the following definition:①not related: there is evidence that the cause of adverse events is not due to intra-articular injection therapy (such as previous conditions, potential diseases, concurrent diseases); ②related: AE and intra-articular injection are time-related and it is known or suspected that intra-articular injection of drugs can cause the AE; ③it can't be assessed.
- VAS score [ Time Frame: 2 years ]VAS score decrease 3 points or more
- WOMAC score [ Time Frame: 2 years ]two or more terms of WOMAC score have improvement.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03357575
|Contact: Ziyi Yang, MDfirstname.lastname@example.org|
|Principal Investigator:||Ziyi Yang||arthritis clinic and research center|