Table 1 Summary of the product development package for a MSC-based medicinal for the treatment of gonarthrosis.

Assessment of long-term effects of autologous MSC treatment in an ovine chronic model of OA [13]

Ovis aries

(Ripollesa breed, ♀); surgically-induced OA

11x10⁶ oMSC; intraarticular

X

X

Biodistribution of hMSC in an immunodeficient mouse model

Mus musculus

(NRG, ♀ and ♂)

4x10⁵ hMSC; tail-vein injection

X

Single-dose toxicology study of intraarticularly administered hMSC in athymic rats

Rattus norvegicus

(NIH nude, ♂)

Up to 6x10⁵ hMSC; intraarticular

X

X

Dose-response study after intraarticular injection of hMSC in a rat model of OA

Rattus norvegicus

(NIH nude, ♂);

MIA-induced OA

Up to 8x10⁴ hMSC; intraarticular

X

X

Analysis of protooncogen expression levels, hTERT activity, senescense, G-banding karyotype, and CGH arrays on clinical grade hMSC

In vitro assays

N/A

X

X

Adult Stem Cell Therapy for Repairing Articular Cartilage in Gonarthrosis (EUDRA-CT: 2009-016449-24; ClinicalTrials.gov Identifier: NCT01227694)

Human(♀ and ♂); grade II/III knee OA

40.9x10⁶ hMSC; intraarticular