Overview

This trial is active, not recruiting.

Condition osteoarthritis of the knee
Treatment human umbilical cord tissue-derived mesenchymal stem cells
Phase phase 1/phase 2
Sponsor Translational Biosciences
Start date September 2014
End date November 2018
Trial size 40 participants
Trial identifier NCT02237846, CNEI-2014-TBS-UCMSCOA-001

Summary

Allogeneic human umbilical cord tissue-derived stem cells injected intravenously (IV) once per day for 3 days or once intra-articularly are a safe and will induce a therapeutic effect in osteoarthritis (OA) patients.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Human umbilical cord tissue-derived mesenchymal stem cells administered into the knee joint once
human umbilical cord tissue-derived mesenchymal stem cells
(Active Comparator)
Human umbilical cord tissue-derived mesenchymal stem cells administered once per day for 3 consecutive days
human umbilical cord tissue-derived mesenchymal stem cells

Primary Outcomes

Measure
Number of participants with adverse events
time frame: 3 months and 12 months

Secondary Outcomes

Measure
Number of participants with a change in joint function from baseline WOMAC assessment
time frame: 3 months and 12 months
Number of participants with a change in radiogrpahic evidence of knee OA from baseline Kellegren-Lawrence grading system
time frame: 3 months and 12 months

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: - Signed informed consent by the subject. - Age greater than or equal to 18 years - Ability to understand the planned treatment. - Idiopathic or secondary osteoarthritis of the knee with grade 2, 3, or 4 radiographic severity, as defined by the modified Kellgren-Lawrence classification - Must have proof of health insurance coverage for treatment-related fees from a verifiable source or financial means to pay up to $11,500 for treatment-related fees and ancillary study-related expenses. Exclusion Criteria: - Pregnant or lactating women - Women of childbearing potential unwilling to use two forms of contraception - Cognitively impaired adults. - Presence of large meniscal tears ("bucket handle" tears), as detected by clinical examination or by magnetic resonance imaging. - Inflammatory or postinfectious arthritis. - More than 5 degrees of varus or valgus deformity. - Kellgren Lawrence grade 4 osteoarthritis in two compartments (the medial or lateral compartments of the tibiofemoral joint or the patellofemoral compartment) in persons over 60 years of age. - Intraarticular corticosteroid injection within the previous 3 months. - A major neurologic deficit. - Serious medical illness with a life expectancy of less than 1 year. - Prior admission for substance abuse - Body Mass Index (BMI) of 40 kg/m2 or greater - Patient receiving experimental medication or participating in another clinical study within 30 days of signing the informed consent - In the opinion of the investigator or the sponsor the patient is unsuitable for cellular therapy

Additional Information

Official title Clinical Study of Umbilical Cord Tissue Mesenchymal Stem Cells (UC-MSC) for Treatment of Osteoarthritis
Principal investigator Salomon Dayan, MD
Description The proposed study will assess primarily safety and secondary efficacy endpoints of allogeneic umbilical cord mesenchymal stem cells (UC-MSC) administered to 40 patients with OA. Arm 1 will receive one intra-articular injection of UC-MSC into the knee and Arm 2 will receive IV UC-MSC once per day for 3 consecutive days. The primary objective of the trial is freedom from treatment associated adverse events at 3 and 12 months post treatment. Secondary objective will be efficacy as assessed at baseline, and 3 and 12 months post treatment and will be quantified based on the Western Ontario and McMaster osteoarthritis index (WOMAC).
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Translational Biosciences.