Back to resultsThe Maximum Tolerated Dose of Mesenchymal Stem Cells From Umbilical Cord
Primary Purpose
Knee Osteoarthritis, Umbilical Cord Bleeding
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
mesenchymal stem cells
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring mesenchymal stem cells, Knee Osteoarthritis, Umbilical Cord
Eligibility Criteria
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.-
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
low dose of mesenchymal stem cells
medium dose of mesenchymal stem cells
high dose of mesenchymal stem cells
Arm Description
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
the medium-dose is 5 × 10^7cells / 3mL
the high dose is 1 × 10^8cells / 3mL
Outcomes
Primary Outcome Measures
Unexplained local and systemic symptoms or death
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03357770
First Posted
November 25, 2017
Last Updated
November 25, 2017
Sponsor
Peking University People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03357770
Brief Title
The Maximum Tolerated Dose of Mesenchymal Stem Cells From Umbilical Cord
Official Title
Evaluating the Maximum Tolerated Dose of Mesenchymal Stem Cells From Umbilical
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Anticipated)
Primary Completion Date
December 1, 2020 (Anticipated)
Study Completion Date
June 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of this study was to evaluate the maximum tolerated dose of Mesenchymal Stem Cells (MSCs) from umbilical cord in the treatment of human knee OA
Detailed Description
This is a single-centre, quadruple blined, randomized controlled trail with a total of 9 knee osteoarthrits patients as participants, who will be randomly assigned into high dose group, moderate dose group or low dose group. The participants in the high dose group will receive the treatment of high dose MSCs (1×10^8cells/3mL) anticular injection.The dose of the MSCs in medium dose group is 5×10^7cells/3mL, and the dose in the low dose group is 1×10^7cells/3mL. Unexplained local and systemic symptoms will be assessed to determine the the maximum tolerated dose of mesenchymal stem cells in anticular injection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Umbilical Cord Bleeding
Keywords
mesenchymal stem cells, Knee Osteoarthritis, Umbilical Cord
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
9 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
low dose of mesenchymal stem cells
Arm Type
Experimental
Arm Description
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
Arm Title
medium dose of mesenchymal stem cells
Arm Type
Experimental
Arm Description
the medium-dose is 5 × 10^7cells / 3mL
Arm Title
high dose of mesenchymal stem cells
Arm Type
Experimental
Arm Description
the high dose is 1 × 10^8cells / 3mL
Intervention Type
Drug
Intervention Name(s)
mesenchymal stem cells
Intervention Description
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
Primary Outcome Measure Information:
Title
Unexplained local and systemic symptoms or death
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ziyi Yang
Phone
+86 18810335110
Email
bjmuyangziyi@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianhao Lin, MD
Organizational Affiliation
arthritis clinic and research center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Maximum Tolerated Dose of Mesenchymal Stem Cells From Umbilical Cord
We'll reach out to this number within 24 hrs