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

Translational Biosciences

Status and phase

Withdrawn

Phase 2

Phase 1

Conditions

Osteoarthritis of the Knee

Treatments

Biological: Human umbilical cord tissue-derived mesenchymal stem cells

Study type

Interventional

Funder types

Industry

Identifiers

NCT02237846

CNEI-2014-TBS-UCMSCOA-001

Details and patient eligibility

About

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.

Full 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).

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

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