A Prospective, Randomized, Masked, and Placebo-Controlled Efficacy Study of Intraarticular Allogeneic Adipose Stem Cells for the Treatment of Osteoarthritis in Dogs.
Osteoarthritis (OA) is a degenerative joint disease with a high prevalence in dogs. Mesenchymal stem cells (MSCs) have been used to treat humans, dogs, and horses with OA. This report describes a prospective, randomized, blinded, and placebo-controlled clinical efficacy study of intraarticular allogeneic adipose stem cells for the treatment of dogs with OA. Health assessments and measurements of pain and activity impairment were performed at baseline and at selected time points through day 60. The primary outcome variable was the owner Client-Specific Outcome Measurement (CSOM) and secondary measures included veterinary pain on manipulation, veterinary global score, and owner global score. The dogs were treated with either a saline placebo or a single dose of allogeneic adipose-derived MSCs in either one or two joints. Seventy-four dogs were statistically analyzed for efficacy outcomes. Success in the primary outcome variable, CSOM, was statistically improved in the treated dogs compared to the placebo dogs (79.2 versus 55.4%,p= 0.029). The veterinary pain on manipulation score (92.8 versus 50.2%,p= 0.017) and the veterinary global score (86.9 versus 30.8%,p= 0.009) were both statistically improved in treated dogs compared to placebo. There was no detected significant difference between treated and placebo dogs in the incidence of adverse events or negative health findings. Allogeneic adipose-derived stem cell treatment was shown to be efficacious compared to placebo. This large study of dogs also provides valuable animal clinical safety and efficacy outcome data to our colleagues developing human stem cell therapy.
VetStem Biopharma, Inc. , Poway, CA , USA.
Robert
R
Harman
VCA Bay Area Veterinary Specialists , San Leandro, CA , USA.
Kim
K
Carlson
Peak Performance Veterinary Group , Frisco, CO , USA.
Jamie
J
Gaynor
Surgery 4 Pets , Portland, OR , USA.
Scott
S
Gustafson
California Veterinary Specialists , Carlsbad, CA , USA.
Sarit
S
Dhupa
Burnt Hills Veterinary Hospital , Burnt Hills, NY , USA.
Keith
K
Clement
Garden State Veterinary Specialists , Tinton Falls, NJ , USA.
Michael
M
Hoelzler
Cascade Veterinary Referral Center , Tigard, OR , USA.
Tim
T
McCarthy
Animal Medical Center of New York , New York, NY , USA.
Pamela
P
Schwartz
Integrative Sports Rehab and Wellness LLC , Foxfield, CO , USA.
Cheryl
C
Adams
adipose stem cells; adult stem cells; arthritis; clinical translation; dog model; mesenchymal stem cells
Cytotherapy. 2013 Jun;15(6):641-8
23570660
J Am Vet Med Assoc. 2010 Jan 1;236(1):67-73
20043801
Cell Transplant. 2010;19(3):279-89
19995482
Mol Biol Cell. 2002 Dec;13(12):4279-95
12475952
Biochem Biophys Res Commun. 2008 Nov 7;376(1):148-53
18774772
Am J Vet Res. 2013 Dec;74(12):1467-73
24274882
Int J Mol Sci. 2014 Jul 31;15(8):13437-60
25089877
Vet Clin North Am Small Anim Pract. 1997 Jul;27(4):699-723
9243777
Tissue Eng Part A. 2009 Feb;15(2):221-9
18847356
J Cell Biochem. 2006 Aug 1;98(5):1076-84
16619257
Vet Ther. 2007 Winter;8(4):272-84
18183546
Disabil Rehabil. 2008;30(20-22):1752-8
18608378
Pain. 2009 Jun;143(3):238-45
19380203
BMC Vet Res. 2012 Sep 10;8:162
22963751
Vet Clin North Am Small Anim Pract. 2012 Jul;42(4):727-48, vii
22720811
Cell Stem Cell. 2011 Jul 8;9(1):11-5
21726829
Vet Ther. 2003 Winter;4(4):376-86
15136979
Tissue Eng. 2007 Jul;13(7):1615-21
17518742
Curr Rheumatol Rep. 2013 Nov;15(11):375
24072604
Cell Biochem Funct. 2008 Aug;26(6):664-75
18636461
Int Orthop. 2015 Apr;39(4):807-17
25750132
Mol Biol Cell. 2010 Jun 1;21(11):1783-7
20375149
J Vet Pharmacol Ther. 2013 Dec;36(6):609-16
23550740
Vet Ther. 2008 Fall;9(3):192-200
19003780
BMC Vet Res. 2013 Jul 02;9:131
23819757
Am J Vet Res. 2008 Jul;69(7):928-37
18593247
J Am Vet Med Assoc. 2012 Nov 15;241(10):1314-9
23113523
Vet Surg. 2008 Dec;37(8):713-24
19121166
Exp Mol Med. 2013 Nov 15;45:e54
24232253
Biores Open Access. 2013 Aug;2(4):315-25
23914338
J Am Vet Med Assoc. 2008 Oct 15;233(8):1278-83
19180716
J Vet Intern Med. 2008 Jan-Feb;22(1):53-9
18289289