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The goal of this clinical trial is to evaluate the safety and tolerability of human umbilical cord mesenchymal stem cells mediated by arthroscopy in patients with knee osteoarthritis. This experiment proposes to enroll 18-22 patients. The experimental drug is human umbilical cord mesenchymal stem cells.
This study adopts a design for a single-dose increasing, single-center, randomized, placebo-controlled trial to explore the safety, tolerance and preliminary efficacy of the single-dose administration of human umbilical cord mesenchymal stem cells mediated by arthroscopy in patients with knee osteoarthritis, as well as to provide a basis for the subsequent clinical study of drug delivery plans.
The experimental process of this study is divided into four stages: screening period, baseline period, study treatment and safety observation period, follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Human Umbilical Mesenchymal Stem Cells | Experimental | Participants received a single administration for Human Umbilical Mesenchymal Stem Cells during the treatment period.The specification is 2.5 × 10^7cells/2ml suspension/branch. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human Umbilical Mesenchymal Stem Cells | Biological | Ntra-articular injection inject a corresponding dose of cells suspension into each joint cavity according to the lesion site. |
| Measure | Description | Time Frame |
|---|---|---|
| Within 4 weeks after treatment, evaluate the incidence and severity of adverse events. | According to the NCI CTCAE v5.0 grading standard, adverse events in the study will be described and the level of them assessed. Then it will be counted up that the number and incidence of drug-related adverse events/adverse reactions, serious adverse events/serious adverse reactions (level 3 or above), and adverse events/adverse reactions leading to withdrawal in each group during the treatment period. | Within 4 weeks after treatment |
| Within 4 weeks after treatment, evaluate the Maximum Tolerable Dose (MTD). | The degree of adverse events observed in the experiment will be determined according to the NCI CTCAE v5.0 grading standard. If there were drug-related adverse events of level 3 or above that occurred in half or more of the subjects in any dose group before the dose was reached 1.0 × 10^8 cells/person/time, the dose ramp would be terminated and then the previous dose would be defined as MTD. If not, define 1.0 × 10^8 cells/person/time as MTD. | Within 4 weeks after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate changes on the scores of the Western Ontario and McMaster Universities Osteoarthritis Index relative to baseline after treatment | In the Western Ontario and McMaster Universities Osteoarthritis Index, the minimum value is 0 and the maximum value is 96, and higher scores mean a worse outcome. | Baseline, Week 4, Week 12, Week 24 and Week 48 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weijie He | Contact | 15178538969 | heweijie613@163.com | |
| Ethics Committee of Stem cell Clinical Research Institute Wannan Medical College Yijishan Hospital IRB | Contact | 0553-5739184 | yjsyy@heweijie.com |
| Name | Affiliation | Role |
|---|---|---|
| Qiang Wang | First Affiliated Hospital of Wannan Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Wannan Medical College | Recruiting | Wuhu | Anhui | 241000 | China |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Evaluate changes on the degree of the Kellgren-Lawrence grading standard for Knee joint X-ray relative to baseline after treatment | In the Kellgren-Lawrence grading standard for Knee joint X-ray, the lowest class is 0 and the highest class is IV, and higher grade means a worse outcome. | Baseline, Week 24 and Week 48 |
| Evaluate changes on the degree of the Kellgren-Lawrence grading standard for Knee joint MRI relative to baseline after treatment | In the Kellgren-Lawrence grading standard for Knee joint MRI, the lowest class is 0 and the highest class is IV, and higher grade means a worse outcome. | Baseline, Week 24 and Week 48 |
| Evaluate changes on the level of inflammatory factors relative to baseline after treatment | At various time frame (baseline, week 4, week 12, week 24 and week 48), it will be measured that the levels of inflammatory factors (IL-1, IL-6, tumor necrosis factor α, PEG2) in the knee joint cavity. Then the changes on the level of inflammatory factors from baseline after treatment will be assessed. | Baseline, Week 4, Week 12, Week 24 and Week 48 |
| Evaluate changes on the scores of the Visual Analogue Scale relative to baseline after treatment | In the Visual Analogue Scale, the minimum value is 0 and the maximum value is 10, and higher scores mean a worse outcome. | Baseline, Week 4, Week 12, Week 24 and Week 48 |
| Evaluate changes on the scores of the 36-Item Short Form Survey relative to baseline after treatment | In the 36-Item Short Form Survey, the minimum value is 0 and the maximum value is 900, and higher scores mean a better outcome. | Baseline, Week 4, Week 12, Week 24 and Week 48 |
| D012216 |
| Rheumatic Diseases |