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

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.

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).

Study Overview

• Status: Withdrawn
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Biological: Human allogeneic mesenchymal bone marrow derived stem cells

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• Mexico
  • Baja California
    • Tijuana, Baja California, Mexico, 22000
      • Clinica Santa Clarita

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; 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; Intraarticular administration of 20x10^6 MSCs
Experimental: Group 2; 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; Intraarticular administration of 20x10^6 MSCs
Experimental: Group 3; 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; Intraarticular administration of 20x10^6 MSCs

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Clinica Santa Clarita, Mexico
• Investigators: Principal Investigator: José F Izquierdo, M.D., External

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2019
• Primary Completion (Anticipated): April 1, 2020
• Study Completion (Anticipated): April 1, 2020

Study Registration Dates

• First Submitted: July 17, 2018
• First Submitted That Met QC Criteria: July 25, 2018
• First Posted (Actual): July 27, 2018

Study Record Updates

• Last Update Posted (Actual): July 15, 2020
• Last Update Submitted That Met QC Criteria: July 13, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Knee osteoarthritis, safety, MSCs
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: PRO-OAR-BW-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes