NCT04314661

Brief Summary

This study aims to compare the efficacy of Umbilical Cord Mesenchymal Stem Cell and secretome between arthroscopy and without arthroscopy intervention in OA patients. This study has 4 arms namely Arthroscopy + Booster, Arthroscopy + Pre-conditioning, Non-Arthroscopy + Booster, Non-Arthroscopy + Pre-conditioning.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2020

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

February 19, 2020

Completed
29 days until next milestone

First Posted

Study publicly available on registry

March 19, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

August 3, 2020

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2024

Completed
Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

3.9 years

First QC Date

February 19, 2020

Last Update Submit

February 23, 2026

Conditions

Osteoarthritis, Knee

Keywords

OsteoarthritisAllogeneic Mesenchymal Stem CellsUmbilical CordConditioned Medium

Outcome Measures

Primary Outcomes (6)

  • Visual Analog Scale (VAS)

    To asses pain score, score 1(good)-10(worst)

    1 month after injection

  • Visual Analog Scale (VAS)

    To asses pain score, score 1(good)-10(worst)

    3 month after injection

  • Visual Analog Scale (VAS)

    To asses pain score, score 1(good)-10(worst)

    6 month after injection

  • Western Ontario and McMaster Universities Osteoarthritis Index

    To evaluate the condition of patients with osteoarthritis, including pain, stiffness, and physical functioning of the joints.

    1 month after injection

  • Western Ontario and McMaster Universities Osteoarthritis Index

    To evaluate the condition of patients with osteoarthritis, including pain, stiffness, and physical functioning of the joints.

    3 month after injection

  • Western Ontario and McMaster Universities Osteoarthritis Index

    To evaluate the condition of patients with osteoarthritis, including pain, stiffness, and physical functioning of the joints.

    6 month after injection

Secondary Outcomes (4)

  • Laboratory Asessment

    2 weeks after injection

  • Laboratory Asessment

    1 month after injection

  • Laboratory Asessment

    3 months after injection

  • Magnetic Resonance Imaging (MRI) T2 mapping

    6 month after injection

Study Arms (4)

Arthroscopy + Booster

EXPERIMENTAL

After arthroscopy intervention, patient will be given 10 million UC-MSCs and 2 cc Secretome twice with 2 weeks interval via intra-articular injection.

Biological: Arthroscopy with Mesenchymal Stem Cells + Secretome + Secretome

Arthroscopy + Pre-Conditioning

EXPERIMENTAL

After arthroscopy intervention, patient will be given 2 cc Secretome, 10 million UC-MSCs, and 2 cc Secretome with 2 weeks interval via intra-articular injection.

Biological: Arthroscopy with Secretome + Mesenchymal Stem Cells + Secretome

Non Arthroscopy + Booster

EXPERIMENTAL

Without arthroscopy intervention, patient will be given 10 million UC-MSCs and 2 cc Secretome twice with 2 weeks interval via intra-articular injection.

Biological: Non Arthroscopy with Mesenchymal Stem Cells + Secretome + Secretome

Non Arthroscopy + Pre-Conditioning

EXPERIMENTAL

Without arthroscopy intervention, patient will be given 2 cc Secretome, 10 million UC-MSCs, and 2 cc Secretome with 2 weeks interval via intra-articular injection.

Biological: Non Arthroscopy with Secretome + Mesenchymal Stem Cells + Secretome

Interventions

Arthroscopy with Secretome + Mesenchymal Stem Cells + SecretomeBIOLOGICAL

After Arthroscopy intervention, patient recieve 2 cc Secretome, two weeks afterward patient receive 10 million Allogeneic Umbilical Cord Mesenchymal Stem Cells in 2 cc NaCl, and four weeks later, patient receive another 2 cc Secretome. All intervention will be done via Intra-articular.

Arthroscopy + Pre-Conditioning
Non Arthroscopy with Mesenchymal Stem Cells + Secretome + SecretomeBIOLOGICAL

Without Arthroscopy intervention, patient recieve 10 million Allogeneic Umbilical Cord Mesenchymal Stem Cells in 2 cc NaCl, two weeks afterward, patient receive 2 cc Secretome, and four weeks later, patient receive another 2 cc Secretome. All intervention will be done via Intra-articular.

Also known as: Secretome
Non Arthroscopy + Booster
Non Arthroscopy with Secretome + Mesenchymal Stem Cells + SecretomeBIOLOGICAL

Without Arthroscopy intervention, patient recieve 2 cc Secretome, two weeks afterward patient receive 10 million Allogeneic Umbilical Cord Mesenchymal Stem Cells in 2 cc NaCl, and four weeks later, patient receive another 2 cc Secretome. All intervention will be done via Intra-articular.

Non Arthroscopy + Pre-Conditioning
Arthroscopy with Mesenchymal Stem Cells + Secretome + SecretomeBIOLOGICAL

After Arthroscopy intervention, patient recieve 10 million Allogeneic Umbilical Cord Mesenchymal Stem Cells in 2 cc NaCl, two weeks afterward, patient receive 2 cc Secretome, and four weeks later, patient receive another 2 cc Secretome. All intervention will be done via Intra-articular.

Arthroscopy + Booster

Eligibility Criteria

Age55 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 55-70 years
  • Suffering from grade 2-3 OA was identified by two observers who differed accordingly Kellgren-Lawrence research scale
  • Absence of local or general infections
  • Haematological and biochemical analysis without significant changes being made cause contraindications
  • Patients can understand the nature of the study
  • Written informed consent is given to patients

You may not qualify if:

  • Patients are not willing to obey the study protocol
  • There are signs of infection or positive serology for HIV, hepatitis and syphilis
  • There is a history of cancer both in the family and yourself and the value of the examination tumour marker exceeds normal limits
  • There is a congenital disease that causes significant deformity of the knee can interfere with cell applications and interpret results
  • Articular injection of the knee by any drug during the previous 3 months
  • Participate in any clinical trial or treatment 30 days before the study
  • Other conditions may, according to medical criteria, not support participation in this research
  • Patients are subordinates or low ranking members

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gatot Soebroto Hospital

Jakarta Pusat, DKI Jakarta, 10410, Indonesia

Location

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Interventions

ArthroscopySecretome

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeOrthopedic ProceduresMetabolomeMetabolism

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2020

First Posted

March 19, 2020

Study Start

August 3, 2020

Primary Completion

July 8, 2024

Study Completion

December 8, 2024

Last Updated

February 25, 2026

Record last verified: 2026-02

Locations

ID(1)