NCT03602872
Withdrawn
Phase 1
Phase I, Open Label Study to Assess the Safety and Tolerance of a Single Intraarticular Dose of STEMEDICA's Human Allogeneic Bone Marrow Derived Mesenchymal Stem Cells, in Subjects With Knee Osteoarthritis.
Clinica Santa Clarita, Mexico1 site in 1 countryAugust 2019
ConditionsKnee Osteoarthritis
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Knee Osteoarthritis
- Sponsor
- Clinica Santa Clarita, Mexico
- Locations
- 1
- Primary Endpoint
- Safety evaluation of all AE/SAEs
- Status
- Withdrawn
- Last Updated
- 5 years ago
Overview
Brief Summary
The aim of this study is to assess the safety of Stemedica's mesenchymal stem cells in patients with knee osteoarthritis. The route of administration is intraarticular. Safety will be evaluated by AE/SAE incidence and administration tolerance. The subjects will undergo follow-up for 52 weeks. The target population is subjects with knee osteoarthritis (grade II-III in Kellgren-Lawrence scale).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female volunteers between 35-65 years.
- •X-ray evidence of osteoarthritis (grade II-III in Kellgren-Lawrence).
- •Chronic joint pain (\>5 visual analogue scale) in knee.
- •Voluntary acceptance and signature of informed consent.
- •Willing to attend study visits and lab sample recollection.
- •Lab values within normal reference values.
- •Willing to use effective birth control methods.
Exclusion Criteria
- •Inflammatory arthritis.
- •Generalized infection.
- •Active cancer or history of cancer in the past 5 years.
- •Receiving oral or intraarticular steroids.
- •Positive labs for HIV, Hepatitis B or C.
- •Recent trauma in the target joint.
- •Debris in joint.
- •Subjects that have undergone or need to undergo arthroscopic knee surgery in the target joint.
- •History of joint substitution, intraarticular fractures, osteotomy, arthroplasty or menisectomy.
- •Clinically significant knee misalignment.
Outcomes
Primary Outcomes
Safety evaluation of all AE/SAEs
Time Frame: From the first dosing of the first subject up to 30 days after the last follow up of the last dosed subject
All AE/SAE will be assessed for causality and reported utilizing MedDRA terminology.
Secondary Outcomes
- OAKHQOL questionnaire(From the first dosing of the first subject up to 30 days after the last follow up of the last dosed subject)
- WOMAC questionnaire(From the first dosing of the first subject up to 30 days after the last follow up of the last dosed subject)
- Procedure tolerance (procedure pain/discomfort incidence)(7 days after subject receives dosing)
Study Sites (1)
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