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

NCT ID: NCT03602872

Last Updated: 2020-07-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-31
• Study Completion Date: 2020-04-30

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).

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Human allogeneic mesenchymal bone marrow derived stem cells

Intervention Type: BIOLOGICAL

Intraarticular administration of 20x10\^6 MSCs

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.

Group Type: EXPERIMENTAL

Human allogeneic mesenchymal bone marrow derived stem cells

Intervention Type: BIOLOGICAL

Intraarticular administration of 20x10\^6 MSCs

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.

Group Type: EXPERIMENTAL

Human allogeneic mesenchymal bone marrow derived stem cells

Intervention Type: BIOLOGICAL

Intraarticular administration of 20x10\^6 MSCs

Interventions

Human allogeneic mesenchymal bone marrow derived stem cells

Intraarticular administration of 20x10\^6 MSCs

Intervention Type: BIOLOGICAL

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.
• 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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinica Santa Clarita, Mexico

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

José F Izquierdo, M.D.

Role: PRINCIPAL_INVESTIGATOR

External

Locations

Clinica Santa Clarita

Tijuana, Estado de Baja California, Mexico

Countries

Mexico

Other Identifiers

PRO-OAR-BW-001

Identifier Type: -

Identifier Source: org_study_id