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

Primary Purpose

Knee Osteoarthritis

Status
Withdrawn
Phase
Phase 1
Locations
Mexico
Study Type
Interventional
Intervention
Human allogeneic mesenchymal bone marrow derived stem cells
Sponsored by
Clinica Santa Clarita, Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Knee osteoarthritis, safety, MSCs

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Clinica Santa Clarita

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group 1

Group 2

Group 3

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Safety evaluation of all AE/SAEs
All AE/SAE will be assessed for causality and reported utilizing MedDRA terminology.

Secondary Outcome Measures

Procedure tolerance (procedure pain/discomfort incidence)
The procedure tolerance will be evaluated through a questionnaire for procedure pain/discomfort incidence.
WOMAC questionnaire
The WOMAC questionnaire will be used to evaluate any preliminary efficacy findings throughout the study completion.
OAKHQOL questionnaire
The OAKHQOL questionnaire will be used to evaluate any preliminary efficacy findings throughout the study completion.

Full Information

First Posted
July 17, 2018
Last Updated
July 13, 2020
Sponsor
Clinica Santa Clarita, Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT03602872
Brief Title
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

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Sponsor to start with different protocol, postponed due to COVID
Study Start Date
August 2019 (Anticipated)
Primary Completion Date
April 2020 (Anticipated)
Study Completion Date
April 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinica Santa Clarita, Mexico

4. Oversight

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

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Knee osteoarthritis, safety, MSCs

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 3
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Human allogeneic mesenchymal bone marrow derived stem cells
Intervention Description
Intraarticular administration of 20x10^6 MSCs
Primary Outcome Measure Information:
Title
Safety evaluation of all AE/SAEs
Description
All AE/SAE will be assessed for causality and reported utilizing MedDRA terminology.
Time Frame
From the first dosing of the first subject up to 30 days after the last follow up of the last dosed subject
Secondary Outcome Measure Information:
Title
Procedure tolerance (procedure pain/discomfort incidence)
Description
The procedure tolerance will be evaluated through a questionnaire for procedure pain/discomfort incidence.
Time Frame
7 days after subject receives dosing
Title
WOMAC questionnaire
Description
The WOMAC questionnaire will be used to evaluate any preliminary efficacy findings throughout the study completion.
Time Frame
From the first dosing of the first subject up to 30 days after the last follow up of the last dosed subject
Title
OAKHQOL questionnaire
Description
The OAKHQOL questionnaire will be used to evaluate any preliminary efficacy findings throughout the study completion.
Time Frame
From the first dosing of the first subject up to 30 days after the last follow up of the last dosed subject

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José F Izquierdo, M.D.
Organizational Affiliation
External
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinica Santa Clarita
City
Tijuana
State/Province
Baja California
ZIP/Postal Code
22000
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No

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

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