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Completed

NCT Number: NCT04314661

Mesenchymal Stem Cell Therapy (MSCs) and Conditioned Medium Therapy for Osteoartrithis

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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

55 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Gatot Soebroto Hospital

Jakarta Pusat, DKI Jakarta, 10410, Indonesia

About this study

The study subjects each group amounted to 5 patients suffering from osteoarthritis. Patients are evaluated before, and 1,3,6 months after injection.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Arthroscopy with Mesenchymal Stem Cells + Secretome + Secretome

Biological

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 with Secretome + Mesenchymal Stem Cells + Secretome

Biological

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.

Non Arthroscopy with Mesenchymal Stem Cells + Secretome + Secretome

Biological

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.

Other names: Secretome

Non Arthroscopy with Secretome + Mesenchymal Stem Cells + Secretome

Biological

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.

Primary outcomes

  1. Visual Analog Scale (VAS)

    Time frame: 1 month after injection

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

  2. Visual Analog Scale (VAS)

    Time frame: 3 month after injection

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

  3. Visual Analog Scale (VAS)

    Time frame: 6 month after injection

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

  4. Western Ontario and McMaster Universities Osteoarthritis Index

    Time frame: 1 month after injection

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

  5. Western Ontario and McMaster Universities Osteoarthritis Index

    Time frame: 3 month after injection

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

  6. Western Ontario and McMaster Universities Osteoarthritis Index

    Time frame: 6 month after injection

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

Secondary outcomes

  1. Laboratory Asessment

    Time frame: 2 weeks after injection

    COMP, MMP-13, IL-6

  2. Laboratory Asessment

    Time frame: 1 month after injection

    COMP, MMP-13, IL-6

  3. Laboratory Asessment

    Time frame: 3 months after injection

    COMP, MMP-13, IL-6

  4. Magnetic Resonance Imaging (MRI) T2 mapping

    Time frame: 6 month after injection

    MRI T2 mapping is used for cartilage evaluation

Sponsors and collaborators

Lead sponsor

PT. Prodia Stem Cell Indonesia

Industry

Registry information

Official study title

Innovative Osteoarthritis Therapy Using Combination of Mesenchymal Stem Cell (MSC) and Conditioned Medium (CM): A Comparative Study on Arthroscopy and Non-Arthroscopy

Acronym: OA

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Mar 19, 2020
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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