NCT03358654

Brief Summary

This study was to evaluate the safety and efficacy of Mesenchymal Stem Cells (MSCs) from umbilical cord in the treatment of 7 knee OA patients by assessing unexplained local and systemic symptoms or death before and at 1, 2, 3, 6 months after the injection.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Status
unknown

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

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 30, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

November 30, 2017

Status Verified

November 1, 2017

Enrollment Period

2.4 years

First QC Date

November 25, 2017

Last Update Submit

November 25, 2017

Conditions

Umbilical Cord BleedingKnee Osteoarthritis

Keywords

Umbilical Cord BleedingKnee Osteoarthritisstem cells

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 (1)

mesenchymal stem cells

EXPERIMENTAL

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

Interventions

mesenchymal stem cells from umbilical cordDRUG

inject mesenchymal stem cells from umbilical cord，and the patients will be followed up at 1, 2, 3, and 6 months after the injection.

mesenchymal stem cells

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Jianhao Lin, MD

    arthritis clinic and research center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ziyi Yang

CONTACT

+86 18810335110bjmuyangziyi@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
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

June 1, 2020

Study Completion

December 1, 2020

Last Updated

November 30, 2017

Record last verified: 2017-11