Table 1 Product specifications of the released expanded Treg products (n = 9)**.

From: A Phase I Clinical Trial with Ex Vivo Expanded Recipient Regulatory T cells in Living Donor Kidney Transplants

Test

Method

Observed Results

Time Testingv Is Performed

Results available prior to release

Bacteriologic sterility

BacTec BD Aerobic and anaerobic system

All Negative

Days 14 & 21

No*

Gram Stain

Mirco Lab SOP

All Negative

Days 14 & 21

Yes

Mycoplasma detection

E-MycoTM PCR

All Negative

Days 14 & 21

Yes

Endotoxin detection

EndoSafe

<0.016EU /kg

Days 14 & 21

Yes

Viability

7AAD staining Flow

>98.3%

Days 14 & 21

Yes

Expression of Treg markers

CD4+CD25+ Flow cytometry

>99.0% CD4+CD25+

Days 14 & 21

Yes

FOXP3 Expression

Intracellular Flow cytometry

>80%

Day 21

Yes

Contamination of CD8+CD19+

CD8+ CD19+ Flow Cytometry

<0.56% CD8+ <0.07% CD20+

Days 14 & 21

Yes

Residual Exp-Act Beads

MiltenyiTM Bead Count Assay

<196.33 beads per 1×108 cells

Day 21

Yes

Potency

MLR suppression assay

>87.6% suppression @ (1:2)

Days 14 & 21

No*

  1. *Day 14 in-process testing was taken into consideration for the release of the Treg product.
  2. **All products met or exceeded IND approved release criteria. Prior to unit infusion, the above release criteria were confirmed and reported to the clinician and regulatory agencies.
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