Safety of Allogeneic Bone Marrow Derived Mesenchymal Stem Cells in Subjects With Osteoarthritis
- Conditions
- Knee Osteoarthritis
- Interventions
- Biological: Human allogeneic mesenchymal bone marrow derived stem cells
- Registration Number
- NCT03602872
- Lead Sponsor
- Clinica Santa Clarita, Mexico
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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.
- BMI ≤ 29.
- 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.
- 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.
- Other illnesses that the investigator considers clinically significant.
- Participating in another clinical trial three months before enrolling.
- Women that are pregnant, lactating or result positive in the pregnancy test during screening.
- Known allergies to bovine products.
- Subjects taking anticoagulants.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Group 1 Human allogeneic mesenchymal bone marrow derived stem cells Subjects will receive a single intraarticular 20x10\^6 dose of Human allogeneic mesenchymal bone marrow derived stem cells, in the most symptomatic target (knee) joint. Group 2 Human allogeneic mesenchymal bone marrow derived stem cells Subjects will receive a single intraarticular 20x10\^6 dose of Human allogeneic mesenchymal bone marrow derived stem cells, in the most symptomatic target (knee) joint. Group 3 Human allogeneic mesenchymal bone marrow derived stem cells Subjects will receive a single intraarticular 20x10\^6 dose of Human allogeneic mesenchymal bone marrow derived stem cells, in the most symptomatic target (knee) joint.
- Primary Outcome Measures
Name Time Method Safety evaluation of all AE/SAEs 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 Outcome Measures
Name Time Method OAKHQOL questionnaire From the first dosing of the first subject up to 30 days after the last follow up of the last dosed subject The OAKHQOL questionnaire will be used to evaluate any preliminary efficacy findings throughout the study completion.
WOMAC questionnaire From the first dosing of the first subject up to 30 days after the last follow up of the last dosed subject The WOMAC questionnaire will be used to evaluate any preliminary efficacy findings throughout the study completion.
Procedure tolerance (procedure pain/discomfort incidence) 7 days after subject receives dosing The procedure tolerance will be evaluated through a questionnaire for procedure pain/discomfort incidence.
Trial Locations
- Locations (1)
Clinica Santa Clarita
🇲🇽Tijuana, Baja California, Mexico