Feasibility and Safety of Allogeneic Adipose Mesenchymal Stem Cells (aMSCs) Delivery Into Kidney Allografts Procured From Deceased Donors With High Kidney Donor Profile Index (KDPI)

Tambi Jarmi

Status and phase: Withdrawn; Phase 1

Conditions: Ischemia Reperfusion Injury

Treatments: Drug: Allogeneic adipose derived mesenchymal stem cells

Study type: Interventional

Funder types: Other

Identifiers

NCT04388761

20-000264

Details and patient eligibility

About

The purpose of this research is to test an investigational drug called Adipose Mesenchymal Stem Cells (aMSCs) for the treatment of ischemia re-perfusion injury (IRI) in patients that have had a kidney transplant.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female kidney transplant candidates age 18 and above.
• Patient is receiving kidney allograft from deceased donor with KDPI>85%.
• Ability of subject to give appropriate consent.
• Females of childbearing potential with agreement to use birth control for six months post-transplant.
• Approved by the Mayo Clinic Transplant Selection Committee.
• Signed Authorization for Donation of Anatomical Gifts on file.

Exclusion criteria

• Positive pregnancy test at the time of the kidney offer is called for the potential recipient.
• Kidney transplant potential recipients with active malignancy (except none melanoma skin malignancies).
• Patients with previous history of solid organ transplant (Heart, Lung, Intestine, Kidney and/or Pancreas).
• Patients with previous history of bone marrow transplant.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

Intra parenchymal injection

Experimental group

Description:

5 subjects will receive AMSCs via direct injection into the kidney parenchyma only

Treatment:

Drug: Allogeneic adipose derived mesenchymal stem cells

Intra-arterial infusion

Experimental group

Description:

5 subjects will receive AMSCs via intra-arterial infusion only

Treatment:

Drug: Allogeneic adipose derived mesenchymal stem cells

Intra parenchymal injection & Intra-arterial infusion

Experimental group

Description:

5 subjects will receive AMSCs via direct injection into the kidney parenchyma and intra-arterial infusion

Treatment:

Drug: Allogeneic adipose derived mesenchymal stem cells