Dose-escalation of Cellistem-OA in Patients With Knee Osteoarthritis (CLT-OA1)
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ClinicalTrials.gov Identifier: NCT03810521 |
Recruitment Status : Unknown
Verified January 2019 by Francisco Espinoza, Universidad de los Andes, Chile.
Recruitment status was: Recruiting
First Posted : January 18, 2019
Last Update Posted : January 18, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Osteoarthritis, Knee | Biological: umbilical cord derived-mesenchymal stromal cells | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 24 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase I Dose-escalation Trial to Assess Safety and Efficacy of Cellistem-OA in Patients With Knee Osteoarthritis (CLT-OA1) |
Estimated Study Start Date : | March 1, 2019 |
Estimated Primary Completion Date : | October 30, 2019 |
Estimated Study Completion Date : | December 30, 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: CLT low-dose
Umbilical cord derived-mesenchymal stromal cells at a dose of 2x10e6 cells / 3mL injected by an intra-articular infiltration of affected knee
|
Biological: umbilical cord derived-mesenchymal stromal cells
Intra-articular infiltration of umbilical cord derived-mesenchymal stromal cells |
Experimental: CLT medium-dose
Umbilical cord derived-mesenchymal stromal cells at a dose of 20x10e6 cells / 3mL injected by an intra-articular infiltration of affected knee
|
Biological: umbilical cord derived-mesenchymal stromal cells
Intra-articular infiltration of umbilical cord derived-mesenchymal stromal cells |
Experimental: CLT high-dose
Umbilical cord derived-mesenchymal stromal cells at a dose of 80x10e6 cells / 3mL injected by an intra-articular infiltration of affected knee
|
Biological: umbilical cord derived-mesenchymal stromal cells
Intra-articular infiltration of umbilical cord derived-mesenchymal stromal cells |
- Incidence of adverse events [ Time Frame: 6 months ]
- Change in WOMAC score [ Time Frame: 6 months ]
- Change in VAS score [ Time Frame: 6 months ]
- Changes in structural joint assessment by MRI [ Time Frame: 6 months ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 30 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient between 30 and 75 years old
- Knee-OA Kellgren Lawrence grade I to III
- Pain density according to visual analogue scale superior or equal to 50 mm
- Patelar condromalacia grade I to III
- Stable joint with normal physical exploration
Exclusion Criteria:
- Bilateral symptomatic disease
- Local or systemic infection
- Neoplasia
- Immunosuppression state
- Pregnancy
- Anticoagulant therapy
- Other types of arthritis
- Symptomatic disease of hip and/or spine
- Intra-articular infiltration with steroids in the last 3 months
- Intra-articular infiltration with hyaluronic acid in the last 12 months

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03810521
Contact: Francisco Espinoza, MD | 56226181008 | fespinoza@uandes.cl | |
Contact: Roberto Bobadilla | 56226181000 | rbobadilla@c4c.cl |
Chile | |
Clínica Universidad de los Andes | Recruiting |
Santiago, Xiii, Chile, 7620001 | |
Contact: Jose Matas, MD 56226181000 jmatas@uandes.cl | |
Contact: Eduardo Carrasco, MD 56226181000 ecarrasco@clinicauandes.cl |
Principal Investigator: | Francisco Espinoza, MD | CMO |
Responsible Party: | Francisco Espinoza, Associate Professor, Universidad de los Andes, Chile |
ClinicalTrials.gov Identifier: | NCT03810521 |
Other Study ID Numbers: |
CLT-OA1 |
First Posted: | January 18, 2019 Key Record Dates |
Last Update Posted: | January 18, 2019 |
Last Verified: | January 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
mesenchymal stromal cells |
Osteoarthritis Osteoarthritis, Knee Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |