Evaluating Safety and Efficacy of Mesenchymal Stem Cells From Umbilical Cord
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|ClinicalTrials.gov Identifier: NCT03358654|
Recruitment Status : Unknown
Verified November 2017 by yangziyi, Peking University People's Hospital.
Recruitment status was: Not yet recruiting
First Posted : November 30, 2017
Last Update Posted : November 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Umbilical Cord Bleeding Knee Osteoarthritis||Drug: mesenchymal stem cells from umbilical cord||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluating the Safety and Efficacy of Mesenchymal Stem Cells From Umbilical Cord in the Treatment of Knee Joint 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
Inject mesenchymal stem cells from umbilical cord. The patients will be followed up at 1, 2, 3, and 6 months after the injection
Drug: mesenchymal stem cells from umbilical cord
inject mesenchymal stem cells from umbilical cord，and the patients will be followed up at 1, 2, 3, and 6 months after the injection.
- Unexplained local and systemic symptoms or death [ Time Frame: 6 months ]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.
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): NCT03358654
|Contact: Ziyi Yang||+86 firstname.lastname@example.org|
|Principal Investigator:||Jianhao Lin, MD||arthritis clinic and research center|