NCT04825730

Brief Summary

This clinical trial is conducted to assess the long-term safety of "jointstem" in patients with degenerative knee arthritis who participated in the previous BS-JS-IIT1 investigator initiated trial.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
44mo left

Started Dec 2023

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress40%
Dec 2023Dec 2029

First Submitted

Initial submission to the registry

March 24, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
2.7 years until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

September 28, 2022

Status Verified

September 1, 2022

Enrollment Period

5 years

First QC Date

March 24, 2021

Last Update Submit

September 26, 2022

Conditions

Degenerative ArthritisKnee Arthritis

Keywords

Stem cellAdipose tissue derived mesenchymal stem cellOsteoarthritisdegenerative arthritislong termBiostarRbio

Outcome Measures

Primary Outcomes (1)

  • Adverse Events

    Incidence of adverse events from baseline to 60 months

    60 Month

Secondary Outcomes (1)

  • Adverse Events (Special Attention Target)

    60 months

Study Arms (1)

Long Term Follow-up after Jointstem Transplantation

EXPERIMENTAL
Drug: JOINTSTEM

Interventions

JOINTSTEMDRUG

JOINTSTEM is an OA treatment that uses autologous adipose-derived mesenchymal stem cells. As it does not use allogenic tissues and is incubated without additional genetic modification or mechanical and chemical modification through differentiation, it is classified as 'autologous cell therapy' and is completely free of immunologic rejection.

Also known as: autologous adipose-derived mesenchymal stem cells
Long Term Follow-up after Jointstem Transplantation

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants of Jointstem IIT by arthroscopy (BS-JS-IIT1)
  • Participants who signed informed consent document of this study

You may not qualify if:

  • No applicable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2021

First Posted

April 1, 2021

Study Start

December 1, 2023

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 31, 2029

Last Updated

September 28, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share