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

NCT03602872 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: PRO-OAR-BW-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

Knee osteoarthritis, safety, MSCs

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Procedure tolerance (procedure pain/discomfort incidence)

  7 days after subject receives dosing

• WOMAC questionnaire

  From the first dosing of the first subject up to 30 days after the last follow up of the last dosed subject

• OAKHQOL questionnaire

  From the first dosing of the first subject up to 30 days after the last follow up of the last dosed subject

Study Arms (3)

Group 1

EXPERIMENTAL

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

Group 2

EXPERIMENTAL

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

Group 3

EXPERIMENTAL

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

Interventions

Human allogeneic mesenchymal bone marrow derived stem cells BIOLOGICAL

Intraarticular administration of 20x10\^6 MSCs

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinica Santa Clarita, Mexico: lead

Study Sites (1)

Clinica Santa Clarita

Tijuana, Estado de Baja California, 22000, Mexico

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• José F Izquierdo, M.D.

  External

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2018
• First Posted: July 27, 2018
• Study Start: August 1, 2019
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: July 15, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)