Status:
WITHDRAWN
Clinical Study of Umbilical Cord Tissue Mesenchymal Stem Cells (UC-MSC) for Treatment of Osteoarthritis
Lead Sponsor:
Translational Biosciences
Conditions:
Osteoarthritis of the Knee
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
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 osteoarthriti...
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 on...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02237846
Start Date
September 1 2014
End Date
August 1 2019
Last Update
August 10 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Stem Cell Instsitute
Panama City, Panama