NCT03800810

Potency of Allogenic Umbilical Cord Mesenchymal Stem Cells for Osteoarthritis Management

Status unknown EARLY_PHASE1 Last updated 21 January 2019

What this trial tests

EARLY_PHASE1 trial testing Hyaluronic Acid in Osteoarthritis, Knee in 9 participants. Status unknown.

Timeline

1 May 2015

Primary endpoint
1 May 2019

1 May 2019

Quick facts

Lead sponsor	Indonesia University
Phase	EARLY_PHASE1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	9
Start date	1 May 2015
Primary completion	1 May 2019
Estimated completion	1 May 2019
Sites	1 location across Indonesia

Drugs / interventions tested

• Hyaluronic Acid (HYALURONIC ACID) — full drug profile →
• Umbilical Cord Mesenchymal Stem Cell — full drug profile →
• Recombinant Human Somatropin — full drug profile →

Conditions studied

• Osteoarthritis, Knee — all drugs for Osteoarthritis, Knee →

Sponsor

Indonesia University

Who can join

Adults 30 to 80, any sex, with Osteoarthritis, Knee. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Cartilage T2 map score
  Time frame: 6 months
  MRI examination of the knee with additional T2 mapping software CartiGram (GE Healthcare, USA). T2 map sequence are obtained from the medial and lateral aspect of both femoral and tibial cartilage.
• IKDC score
  Time frame: 3 months
  Subjective assessment of knee function using the International Knee Documentation Committee Subjective Knee Evaluation form. Scale ranges from 1 to 100, higher value indicates higher function.
• WOMAC score
  Time frame: 3 months
  Subjective assessment of knee function using the the Western Ontario and McMaster Universities Osteoarthritis Index. Scale ranges from 100% to 1%, lower value indicates higher function.
• VAS score
  Time frame: 3 months
  VAS score is used to assess knee pain experienced by subjects.

Sponsor's own description

Prevalence of osteoarthritis increases every year, as a chronic and progressive disease. Osteoarthritis also gives many negative impacts in socio-economic life. Current management of osteoarthritis only aimed to relieve pain but not to resolve the degeneration of cartilage. Mesenchymal stem cell is one kind of adult stem cell that has potency in tissue engineering. Sources of mesenchymal stem cell are bone marrow, adipose tissue and umbilical cord. Researchers want to explore the potential of umbilical cord as the source of allogeneic MSC, because the gaining process of MSC is not invasive. Some countries have started some In vitro studies, Animal studies, and human research, but in Indonesia the study of mesenchymal stem cell implantation from umbilical cord in genu osteoarthritis management has not been reported. This study will be held into two years in Cipto Mangunkusumo Hospital and include 9 participants minimally. The researcher also compares the efficacy and safety of MSC implantation from umbilical cord applied to genu osteoarthritis with synovial artificial and recombinant human growth hormone therapy.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Clinical application of mesenchymal stem cell in regenerative medicine: a narrative review.
   Margiana R, Margiana R, Margiana R, Markov A, et al · · 2022 · cited 263× · PMID 35902958 · DOI 10.1186/s13287-022-03054-0
2. Mesenchymal stem cells in treating human diseases: molecular mechanisms and clinical studies.
   Han X, Liao R, Li X, Zhang C, et al · · 2025 · cited 34× · PMID 40841367 · DOI 10.1038/s41392-025-02313-9
3. Conditioned Medium - Is it an Undervalued Lab Waste with the Potential for Osteoarthritis Management?
   Rosochowicz MA, Lach MS, Richter M, Suchorska WM, et al · · 2023 · cited 17× · PMID 36790694 · DOI 10.1007/s12015-023-10517-1
4. Stem cell injections for osteoarthritis of the knee.
   Whittle SL, Johnston RV, McDonald S, Worthley D, et al · · 2025 · cited 11× · PMID 40169165 · DOI 10.1002/14651858.cd013342.pub2
5. Mesenchymal Stromal Cell-Based Therapy-An Alternative to Arthroplasty for the Treatment of Osteoarthritis? A State of the Art Review of Clinical Trials.
   Maleitzke T, Elazaly H, Festbaum C, Eder C, et al · · 2020 · cited 8× · PMID 32630066 · DOI 10.3390/jcm9072062
6. Evaluating Synergistic Effects of Hyaluronic Acid, Human Umbilical Cord-Derived Mesenchymal Stem Cells, and Growth Hormones in Knee Osteoarthritis: A Multi-Arm Randomized Trial.
   Dilogo IH, Canintika AF, Hartanto BR, Pandelaki J, et al · · 2024 · cited 1× · PMID 39457644 · DOI 10.3390/biomedicines12102332