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Trial record 22 of 56 for:    stem cell arthritis AND bone marrow

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

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ClinicalTrials.gov Identifier: NCT03602872
Recruitment Status : Not yet recruiting
First Posted : July 27, 2018
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Clinica Santa Clarita, Mexico

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).

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Biological: Human allogeneic mesenchymal bone marrow derived stem cells Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: 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.
Biological: Human allogeneic mesenchymal bone marrow derived stem cells
Intraarticular administration of 20x10^6 MSCs

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

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




Primary Outcome Measures :
  1. Safety evaluation of all AE/SAEs [ Time Frame: From the first dosing of the first subject up to 30 days after the last follow up of the last dosed subject ]
    All AE/SAE will be assessed for causality and reported utilizing MedDRA terminology.


Secondary Outcome Measures :
  1. Procedure tolerance (procedure pain/discomfort incidence) [ Time Frame: 7 days after subject receives dosing ]
    The procedure tolerance will be evaluated through a questionnaire for procedure pain/discomfort incidence.

  2. WOMAC questionnaire [ Time Frame: From the first dosing of the first subject up to 30 days after the last follow up of the last dosed subject ]
    The WOMAC questionnaire will be used to evaluate any preliminary efficacy findings throughout the study completion.

  3. OAKHQOL questionnaire [ Time Frame: From the first dosing of the first subject up to 30 days after the last follow up of the last dosed subject ]
    The OAKHQOL questionnaire will be used to evaluate any preliminary efficacy findings throughout the study completion.



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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03602872


Contacts
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Contact: Vanessa Felix, Dr. (52) 664-231-7220 vfelix@clinicasantaclarita.com

Locations
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Mexico
Clinica Santa Clarita Not yet recruiting
Tijuana, Baja California, Mexico, 22000
Contact: Tomas E Gomez    (52) 664-231-7220      
Principal Investigator: José F Izquierdo, M.D.         
Sponsors and Collaborators
Clinica Santa Clarita, Mexico
Investigators
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Principal Investigator: José F Izquierdo, M.D. External

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Responsible Party: Clinica Santa Clarita, Mexico
ClinicalTrials.gov Identifier: NCT03602872     History of Changes
Other Study ID Numbers: PRO-OAR-BW-001
First Posted: July 27, 2018    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by Clinica Santa Clarita, Mexico:
Knee osteoarthritis, safety, MSCs

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases