Clinical trial NCT02237846: Clinical Study of Umbilical Cord Tissue Mesenchymal Stem Cells (UC-MSC) for Treatment of Osteoarthritis
Official title: Clinical Study of Umbilical Cord Tissue Mesenchymal Stem Cells (UC-MSC) for Treatment of Osteoarthritis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Osteoarthritis of the Knee
Keywords: osteoarthritis
knee
stem cells
mesenchymal
umbilical cord
Lead sponsor: Translational Biosciences
Sponsor class: INDUSTRY
First posted: 2014-09-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: 3 months and 12 months
Secondary outcomes:
measure: Number of participants with a change in joint function from baseline WOMAC assessment
timeFrame: 3 months and 12 months
measure: Number of participants with a change in radiogrpahic evidence of knee OA from baseline Kellegren-Lawrence grading system
timeFrame: 3 months and 12 months
Other outcomes:
Locations:
city: Panama City
country: Panama
facility: Stem Cell Instsitute
Study officials:
name: Salomon Dayan, MD
role: PRINCIPAL_INVESTIGATOR
References: