The Maximum Tolerated Dose of Mesenchymal Stem Cells From Umbilical Cord
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ClinicalTrials.gov Identifier: NCT03357770 |
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
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Condition or disease | Intervention/treatment | Phase |
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Knee Osteoarthritis Umbilical Cord Bleeding | Drug: mesenchymal stem cells | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 9 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Evaluating the Maximum Tolerated Dose of Mesenchymal Stem Cells From Umbilical |
Estimated Study Start Date : | January 1, 2018 |
Estimated Primary Completion Date : | December 1, 2020 |
Estimated Study Completion Date : | June 1, 2021 |

Arm | Intervention/treatment |
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Experimental: low dose of mesenchymal stem cells
Three groups of patients were enrolled in this study. Every group includes three patients. The three groups of patients were treated with high, medium and low dose of cytokine.The low-dose is 1 × 10^7cells / 3mL
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Drug: mesenchymal stem cells
we will enroll three groups of patients, and they will be therapized by high, medium, and low-dose cytotoxic respectively to evaluate the dose-limiting toxicity (DLT) and establish the maximum tolerated dose (MTD). Dose and cell concentration selection will be based on previous literature [5]. The low-dose is 1 × 10^7cells / 3mL, the medium-dose is 5 × 10^7cells / 3mL and the high dose is 1 × 10^8cells / 3mL |
Experimental: medium dose of mesenchymal stem cells
the medium-dose is 5 × 10^7cells / 3mL
|
Drug: mesenchymal stem cells
we will enroll three groups of patients, and they will be therapized by high, medium, and low-dose cytotoxic respectively to evaluate the dose-limiting toxicity (DLT) and establish the maximum tolerated dose (MTD). Dose and cell concentration selection will be based on previous literature [5]. The low-dose is 1 × 10^7cells / 3mL, the medium-dose is 5 × 10^7cells / 3mL and the high dose is 1 × 10^8cells / 3mL |
Experimental: high dose of mesenchymal stem cells
the high dose is 1 × 10^8cells / 3mL
|
Drug: mesenchymal stem cells
we will enroll three groups of patients, and they will be therapized by high, medium, and low-dose cytotoxic respectively to evaluate the dose-limiting toxicity (DLT) and establish the maximum tolerated dose (MTD). Dose and cell concentration selection will be based on previous literature [5]. The low-dose is 1 × 10^7cells / 3mL, the medium-dose is 5 × 10^7cells / 3mL and the high dose is 1 × 10^8cells / 3mL |
- 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.

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
① K / L score of 2-3; ② chronic knee pain; ③ no local or systemic infection; ④ without obvious contraindication of the joint puncture from hematology and biochemical tests; ⑤ informed consent. -
Exclusion Criteria:
① older than 75 years old or less than 18 years old, or without full capacity for civil conduct; ② HIV, hepatitis virus or syphilis virus infection or their serology is positive; ③ BMI index is greater than 30; ④ congenital or acquired knee deformity; ⑤ pregnant or lactating women; ⑥ tumor patients; ⑦ immunodeficiency patients; ⑧ intra-articular drug injection history within 3 months; ⑨ participating in other clinical trials; ⑩ other patients who researchers believe are not eligible for inclusion such as suffering from other concomitant diseases.-

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): NCT03357770
Contact: Ziyi Yang | +86 18810335110 | bjmuyangziyi@163.com |
Principal Investigator: | Jianhao Lin, MD | arthritis clinic and research center |
Responsible Party: | yangziyi, arthritis clinic and research center, Peking University People's Hospital |
ClinicalTrials.gov Identifier: | NCT03357770 |
Other Study ID Numbers: |
PUPH20170910 |
First Posted: | November 30, 2017 Key Record Dates |
Last Update Posted: | November 30, 2017 |
Last Verified: | November 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
mesenchymal stem cells Knee Osteoarthritis Umbilical Cord |
Osteoarthritis Osteoarthritis, Knee Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |