Safety of Allogeneic Bone Marrow Derived Mesenchymal Stem Cells in Subjects With Osteoarthritis

Study Overview
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Brief Summary
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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).

Official Title
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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.

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Biological: Human allogeneic mesenchymal bone marrow derived stem cells


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>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. | Biological: Human allogeneic mesenchymal bone marrow derived stem cells<br>* Intraarticular administration of 20x10^6 MSCs<br>|
| Experimental: Group 2<br>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. | Biological: Human allogeneic mesenchymal bone marrow derived stem cells<br>* Intraarticular administration of 20x10^6 MSCs<br>|
| Experimental: Group 3<br>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. | Biological: Human allogeneic mesenchymal bone marrow derived stem cells<br>* Intraarticular administration of 20x10^6 MSCs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety evaluation of all AE/SAEs | All AE/SAE will be assessed for causality and reported utilizing MedDRA terminology. | From the first dosing of the first subject up to 30 days after the last follow up of the last dosed subject | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure tolerance (procedure pain/discomfort incidence) | The procedure tolerance will be evaluated through a questionnaire for procedure pain/discomfort incidence. | 7 days after subject receives dosing | 
| WOMAC questionnaire | The WOMAC questionnaire will be used to evaluate any preliminary efficacy findings throughout the study completion. | From the first dosing of the first subject up to 30 days after the last follow up of the last dosed subject | 
| OAKHQOL questionnaire | The OAKHQOL questionnaire will be used to evaluate any preliminary efficacy findings throughout the study completion. | From the first dosing of the first subject up to 30 days after the last follow up of the last dosed subject | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Knee osteoarthritis, safety, MSCs