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

Osteoarthritis of the Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02237846
• Other study ID #: CNEI-2014-TBS-UCMSCOA-001
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: September 9, 2014
• Last updated: August 8, 2017
• Start date: September 2014
• Est. completion date: August 2019

Study information

• Verified date: August 2017
• Source: Translational Biosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2019
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Biological:
• Human umbilical cord tissue-derived mesenchymal stem cells

Locations

Country	Name	City	State
Panama	Stem Cell Instsitute	Panama City

Sponsors (1)

Lead Sponsor	Collaborator
Translational Biosciences

Country where clinical trial is conducted

Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events		3 months and 12 months
Secondary	Number of participants with a change in joint function from baseline WOMAC assessment		3 months and 12 months
Secondary	Number of participants with a change in radiogrpahic evidence of knee OA from baseline Kellegren-Lawrence grading system		3 months and 12 months