Knee Osteoarthritis
Conditions
Keywords
Knee osteoarthritis, safety, MSCs
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).
Interventions
BIOLOGICALHuman allogeneic mesenchymal bone marrow derived stem cells
Intraarticular administration of 20x10\^6 MSCs
Sponsors
Clinica Santa Clarita, Mexico
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 65 Years
Healthy volunteers
No
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. * 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.
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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
Mexico
Outcome results
None listed