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

S

Santa Clarita Clinic (CSC)

Status and phase

Withdrawn
Phase 1

Conditions

Knee Osteoarthritis

Treatments

Biological: Human allogeneic mesenchymal bone marrow derived stem cells

Study type

Interventional

Funder types

Industry

Identifiers

NCT03602872
PRO-OAR-BW-001

Details and patient eligibility

About

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).

Sex

All

Ages

35 to 65 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

0 participants in 3 patient groups

Group 1
Experimental group
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.
Treatment:
Biological: Human allogeneic mesenchymal bone marrow derived stem cells
Group 2
Experimental group
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.
Treatment:
Biological: Human allogeneic mesenchymal bone marrow derived stem cells
Group 3
Experimental group
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.
Treatment:
Biological: Human allogeneic mesenchymal bone marrow derived stem cells

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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