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Clinical Trials

We conduct carefully-planned clinical trials to evaluate the safety and effectiveness of our technologies. Each of our studies is supported by a wealth of in vivo and in vitro data and complies with local clinical trial regulations.

2022

Encapsulated Acellular System From Mesenchymal Stem Cells for Dental Pulp Regeneration

  • Condition or Disease: Periapical Periodontitis
  • Enrollment: 10 participants
  • Status: Recruiting
  • Clinicaltrials.gov identifier (NCT number): NCT05599087
  • Country: Chile
  • Official Title: Encapsulated Acellular System From Mesenchymal Stem Cells for Endodontic Treatment of Patients With Apical Periodontitis: Phase I Clinical Trial
  • Allocation: N/A
  • Number of Arms: 1
  • Masking: None (Open Label)

2021

Intra-articular Injection of MSC-derived Exosomes in Knee Osteoarthritis (ExoOA-1)

  • Condition or Disease: Knee Osteoarthritis
  • Enrollment: 10 participants
  • Status: Recruiting
  • Clinicaltrials.gov identifier (NCT number): NCT05060107
  • Country: Chile
  • Official Title: A Phase I Study Aiming to Assess Safety and Efficacy of a Single Intra-articular Injection of MSC-derived Exosomes (CelliStem®OA-sEV) in Patients With Moderate Knee Osteoarthritis (ExoOA-1)
  • Allocation: N/A
  • Number of Arms: 1
  • Masking: None (Open Label)

Cell Therapy With Cellistem-OA for Symptomatic Knee Osteoarthritis

  • Condition or Disease: Knee Osteoarthritis
  • Enrollment: 30 participants
  • Status: Not yet recruiting
  • Clinicaltrials.gov identifier (NCT number): NCT04863183
  • Country: Colombia
  • Official Title: Cell Therapy for Patients With Symptomatic Knee Osteoarthritis: Phase I / II, Controlled, Randomized and Double-blind Clinical Trial
  • Allocation: Randomized
  • Number of Arms: 2
  • Masking: Triple (Participant, Care Provider, Investigator)

2019

Dose-escalation of Cellistem-OA in Patients With Knee Osteoarthritis (CLT-OA1)

  • Condition or Disease: Knee Osteoarthritis
  • Enrollment: 24 participants
  • Status: Completed
  • Clinicaltrials.gov identifier (NCT number): NCT03810521
  • Country: Chile
  • Official Title: A Phase I Dose-escalation Trial to Assess Safety and Efficacy of Cellistem-OA in Patients With Knee Osteoarthritis (CLT-OA1)
  • Allocation: Randomized
  • Number of Arms: 3
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

The Effectiveness of Adding Allogenic Stem Cells After Traditional Treatment of Osteochondral Lesions of the Talus (OLT)

  • Condition or Disease: Osteochondral Fracture of Talus
  • Enrollment: 70 participants
  • Status: Recruiting
  • Clinicaltrials.gov identifier (NCT number): NCT03905824
  • Country: Chile
  • Official Title: Randomized, Multicentric, Prospective, Double-blind Study: Effectiveness of Adding Allogenic Stem Cells to a Platelet-poor Plasma Scaffold After Arthroscopic Debridement and Microfractures in Patients With Osteochondral Lesions of the Talus
  • Allocation: Randomized
  • Number of Arms: 2
  • Masking: Double (Participant, Outcomes Assessor)

Mesenchymal Stromal Cells (MSC´s) in Renal Lupus (MSC-ROLE)

  • Condition or Disease: Systemic Lupus Erythematosus, Lupus Glomerulonephritis
  • Enrollment: 39 participants
  • Status: Recruiting
  • Clinicaltrials.gov identifier (NCT number): NCT03917797
  • Country: Chile
  • Official Title: Dose-response and Efficacy of Umbilical Cord-derived Mesenchymal Stromal Cells in Renal Systemic Lupus Erythematosus
  • Allocation: Randomized
  • Number of Arms: 2
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

2017

Encapsulated Mesenchymal Stem Cells for Dental Pulp Regeneration. (RanoKure)

  • Condition or Disease: Periapical Periodontitis
  • Enrollment: 36 participants
  • Status: Completed
  • Clinicaltrials.gov identifier (NCT number): NCT03102879
  • Country: Chile
  • Official Title: Encapsulated Mesenchymal Stem Cells for Endodontic Treatment of Permanent Teeth With Apical Lesion: a Controlled Clinical Trial
  • Allocation: Randomized
  • Number of Arms: 2
  • Masking: Triple (Participant, Investigator, Outcomes Assessor)

2015

A Study to Assess Safety and Efficacy of Umbilical Cord-derived Mesenchymal Stromal Cells in Knee Osteoarthritis

  • Condition or Disease: Knee Osteoarthritis
  • Enrollment: 30 participants
  • Status: Completed
  • Clinicaltrials.gov identifier (NCT number): NCT02580695
  • Country: Chile
  • Official Title: A Phase I/II, Randomized, Double-blind, Controlled Study to Assess Safety and Efficacy of Umbilical Cord-derived Mesenchymal Stromal Cells (UC-MSCs) in Patients With Knee Osteoarthritis
  • Number of Arms: 2 (Hyaluronic Acid (active comparator) vs. UC-MSCs (single or double infusion))
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

2012

Randomized Clinical Trial of Intravenous Infusion Umbilical Cord Mesenchymal Stem Cells on Cardiopathy (RIMECARD)

  • Condition or Disease: Dilated Cardiomyopathy
  • Enrollment: 30 participants
  • Status: Completed
  • Clinicaltrials.gov identifier (NCT number): NCT01739777
  • Country: Chile
  • Official Title: Phase 1 Randomized-Double Blind Clinical Trial of Intravenous Infusion of Umbilical Cord Mesenchymal Stem Cells Transplantation in Heart Failure on Patients With Cardiopathy in Dilated Stage, of Different Etiology
  • Allocation: Randomized
  • Number of Arms: 2
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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