Clinical trial NCT03602872: Safety of Allogeneic Bone Marrow Derived Mesenchymal Stem Cells in Subjects With Osteoarthritis
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.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Knee Osteoarthritis
Keywords: Knee osteoarthritis, safety, MSCs
Lead sponsor: Clinica Santa Clarita, Mexico
Sponsor class: INDUSTRY
First posted: 2018-07-27
Enrollment: 0
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Safety evaluation of all AE/SAEs
timeFrame: From the first dosing of the first subject up to 30 days after the last follow up of the last dosed subject
Secondary outcomes:
measure: Procedure tolerance (procedure pain/discomfort incidence)
timeFrame: 7 days after subject receives dosing
measure: WOMAC questionnaire
timeFrame: From the first dosing of the first subject up to 30 days after the last follow up of the last dosed subject
measure: OAKHQOL questionnaire
timeFrame: From the first dosing of the first subject up to 30 days after the last follow up of the last dosed subject
Other outcomes:
Locations:
city: Tijuana
country: Mexico
facility: Clinica Santa Clarita
state: Baja California
Study officials:
affiliation: External
name: José F Izquierdo, M.D.
role: PRINCIPAL_INVESTIGATOR
References: