NCT06688318

Effectivity of Allogenic Umbilical Cord Mesenchymal Stem Cells Conditioned Media for Osteoarthritis of the Knee Joint

Active, enrolled Phase 1, PHASE2 Last updated 15 November 2024

What this trial tests

Phase 1, PHASE2 trial testing Intra-articular secretome injection therapy in Osteoarthritis Knee in 11 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

3 April 2024

Primary endpoint
1 September 2024

1 December 2024

Quick facts

Lead sponsor	Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia
Phase	Phase 1, PHASE2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	11
Start date	3 April 2024
Primary completion	1 September 2024
Estimated completion	1 December 2024
Sites	1 location across Indonesia

Drugs / interventions tested

• Intra-articular secretome injection therapy — full drug profile →

Conditions studied

• Osteoarthritis Knee — all drugs for Osteoarthritis Knee →

Sponsor

Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia — full company profile →

Who can join

45 Months and older, any sex, with Osteoarthritis Knee. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Osteoarthritis (OA) is a joint disorder that often occurs and causes disability. This disorder is characterized by an inflammatory reaction in the synovial joints accompanied by a gradual degeneration process in the articular cartilage and sub-chondral bone. Current research has discovered that stem cells produce conditioned media (secretome, extra vesicles, and exosomes) that have tissue regeneration, immunomodulation, anti-inflammatory, and anti-apoptotic capabilities. Research on conditioned media for umbilical cord mesenchymal stem cells is still at the in vivo stage in experimental animals. For this reason, this study aims to conduct clinical experimental research (translational study) in patients with knee joint OA who were given umbilical cord mesenchymal stem cell conditioned media via intra-articular injection.

Publications & conference data

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

1. Hypoxia-induced metabolic reprogramming in mesenchymal stem cells: unlocking the regenerative potential of secreted factors.
   Jaraba-Álvarez WV, Uscanga-Palomeque AC, Sanchez-Giraldo V, Madrid C, et al · · 2025 · cited 11× · PMID 40552309 · DOI 10.3389/fcell.2025.1609082
2. Therapeutic Efficacy and Promise of Human Umbilical Cord Mesenchymal Stem Cell-Derived Extracellular Vesicles in Aging and Age-Related Disorders.
   Zhang A, Li Q, Chen Z. · · 2024 · cited 7× · PMID 39796081 · DOI 10.3390/ijms26010225
3. Cell-Free Therapies for Chronic Pain: The Rise of the Mesenchymal Stem Cell Secretome.
   Amodeo G, Galimberti G, Niada S, Giannasi C, et al · · 2025 · PMID 41440059 · DOI 10.3390/brainsci15121263
4. Mesenchymal Stem Cell-Derived Extracellular Vesicles: Seeking into Cell-Free Therapies for Bone-Affected Lysosomal Storage Disorders.
   Leal AF, Pachajoa H, Tomatsu S. · · 2025 · PMID 40650223 · DOI 10.3390/ijms26136448
5. Evaluation of cognitive and mobility function in geriatric dogs following treatment with stem cell and stem cell extracellular vesicles derived from embryonic stem cells: a pilot study.
   Kim TY, Kim NH, Chae JA, Oh HK, et al · · 2025 · PMID 40206251 · DOI 10.3389/fvets.2025.1549870