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

Knee Osteoarthritis Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03602872
• Other study ID #: PRO-OAR-BW-001
• Status: Withdrawn
• Phase: Phase 1
• Start date: August 2019
• Est. completion date: April 2020

Study information

• Verified date: July 2020
• Source: Clinica Santa Clarita, Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Biological:
• Human allogeneic mesenchymal bone marrow derived stem cells
Intraarticular administration of 20x10^6 MSCs

Locations

Country	Name	City	State
Mexico	Clinica Santa Clarita	Tijuana	Baja California

Sponsors (1)

Lead Sponsor	Collaborator
Clinica Santa Clarita, Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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