Clinical Study of Umbilical Cord Tissue Mesenchymal Stem Cells (UC-MSC) for Treatment of Osteoarthritis

NCT02237846 | Withdrawn Phase 1

• 1 other identifier: CNEI-2014-TBS-UCMSCOA-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoarthritis of the Knee

Keywords

osteoarthritis; knee; stem cells; mesenchymal; umbilical cord

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events

  3 months and 12 months

Secondary Outcomes (2)

• Number of participants with a change in joint function from baseline WOMAC assessment

  3 months and 12 months

• Number of participants with a change in radiogrpahic evidence of knee OA from baseline Kellegren-Lawrence grading system

  3 months and 12 months

Study Arms (2)

Intra-articular knee injection of UC-MSC

ACTIVE COMPARATOR

Human umbilical cord tissue-derived mesenchymal stem cells administered into the knee joint once

Biological: Human umbilical cord tissue-derived mesenchymal stem cells

IV injection of UC-MSC

ACTIVE COMPARATOR

Human umbilical cord tissue-derived mesenchymal stem cells administered once per day for 3 consecutive days

Biological: Human umbilical cord tissue-derived mesenchymal stem cells

Interventions

Human umbilical cord tissue-derived mesenchymal stem cells BIOLOGICAL

IV injection of UC-MSC; Intra-articular knee injection of UC-MSC

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Translational Biosciences: lead

Study Sites (1)

Stem Cell Instsitute

Panama City, Panama

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Salomon Dayan, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2014
• First Posted: September 11, 2014
• Study Start: September 1, 2014
• Primary Completion: November 1, 2018
• Study Completion: August 1, 2019
• Last Updated: August 10, 2017

Record last verified: 2017-08

Locations

PA (1)