The Maximum Tolerated Dose of Mesenchymal Stem Cells From Umbilical Cord
Evaluating the Maximum Tolerated Dose of Mesenchymal Stem Cells From Umbilical
1 other identifier
interventional
9
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable knee-osteoarthritis
Started Jan 2018
Longer than P75 for not_applicable knee-osteoarthritis
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 25, 2017
CompletedFirst Posted
Study publicly available on registry
November 30, 2017
CompletedStudy Start
First participant enrolled
January 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedNovember 30, 2017
November 1, 2017
2.9 years
November 25, 2017
November 25, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
6 months
Study Arms (3)
low dose of mesenchymal stem cells
EXPERIMENTALThree 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
medium dose of mesenchymal stem cells
EXPERIMENTALthe medium-dose is 5 × 10\^7cells / 3mL
high dose of mesenchymal stem cells
EXPERIMENTALthe high dose is 1 × 10\^8cells / 3mL
Interventions
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
Eligibility Criteria
You may qualify if:
- 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. -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jianhao Lin, MD
arthritis clinic and research center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- arthritis clinic and research center
Study Record Dates
First Submitted
November 25, 2017
First Posted
November 30, 2017
Study Start
January 1, 2018
Primary Completion
December 1, 2020
Study Completion
June 1, 2021
Last Updated
November 30, 2017
Record last verified: 2017-11
Data Sharing
- IPD Sharing
- Will not share