Table 1 Clinical trials related to use of MSCs for organ transplantation
Organ transplanted | MSC source | MSC dosage | IS regime | Route of administration | Patients enrolled/ estimated enrolment | Trial phase | Status |
|---|---|---|---|---|---|---|---|
Kidney | Autologous Bone marrow-derived MSCs (BM-MSCs) | Doses for different groups 2 × 106 MSCs/kg, 48 h before Tx 2 × 106 MSCs/kg + 5 × 106 cell, 48 h before Tx 2 × 106 MSCs/kg at day 1, day 7 | Anti-thymocyte globulin (ATG), Prednisolone, Mycophenolate mofetil (MMF), Calcineurin inhibitor (CNI), IVIG ATG Plasma exchange, IVIG, anti-CD20 monoclonal antibody | Intravenous (I.V.) or intra-arterial (I.A.) I.V.+ I.A. I.V. | 260 | 1 | Enrolling NCT number-NCT02490020 |
Liver | Umbilical cord Derived MSCs (UC-MSCs) | Multiple doses: 1 × 106 MSCs/kg body weight for 12 weeks (once per 4 weeks) | Not mentioned | I.V. | 50 | 1 | Unknown NCT number-NCT01690247 |
Kidney | Third party BM-MSCs | Four doses: 1 * 106/kg every week | Not mentioned | I.V. | 120 | 1/2 | Ongoing NCT number-NCT02563366 |
Kidney | Autologous, BM-MSCs | Single dose 2 × 106 MSCs/kg body wt given 1 day before Tx | MMF, Tacrolimus (TAC) CsA, Steroids | I.V. | 159 | 2 | Completed NCT number-NCT00658073 [62] |
Kidney | Autologous, BM-MSCs | Two doses: 1–2 × 106 MSCs/kg during Tx and day 7 post Tx | MMF, TAC or CsA, Prednisolone | I.V. | 15 | 1 | Completed NCT number-NCT00734396 [63] |
Kidney | Autologous, BM-MSCs | Single dose 2 × 106 MSCs/kg body wt given 1 day before transplantation (Tx) | ATG, MMF, Cyclosporine A (CsA), Steroids | I.V. | 4 | 1/2 | Terminated NCT number-NCT00752479 [69] |
Kidney | Allogeneic, BM-MSCs | Two doses: 1st dose of 1–2 × 106 cells/kg 1 day before Tx, 2nd dose- 1–2 × 106 cells 30 days after Tx | TAC, MMF, Prednisolone | I.V. | 15 | 1 | Active, not recruiting NCT number-NCT02409940 |
Kidney/liver | Allogeneic, BM-MSCs (Third party) | Single dose of 1.5–3 × 106 MSCs/kg at 3 (± 2) days after Tx | TAC, MMF, Steroids | Not mentioned | 40 | 1/2 | Unknown NCT number-NCT01429038 |
Kidney | Allogeneic, BM-MSCs (Third party) | 4 doses: 1 × 106 cells/kg during Tx and at day 7, 14, 21 post-Tx | Induction with basiliximab, Low dose of TAC, MMF, Steroids | I.V. | 120 | 1/2 | Not yet recruiting, NCT number-NCT02561767 |
Kidney | Autologous, stromal vascular fraction derived MSCs | 4 doses: 1 × 106 cells/kg during Tx and at day 7, 14, 21 post-Tx | Basiliximab induction | Not mentioned | 120 | 1/2 | Not yet recruiting, NCT number-NCT02492308 |
Liver | Allogeneic, BM-MSCs | Two doses: 1 × 106 MSCs/kg during Tx and day 2 (± 1) post-Tx | TAC, Basiliximab, Steroids | 1st dose: intraportal infusion, 2nd dose: I.V. | 7 | 1 (Pilot study) | Recruiting NCT number-NCT02957552 |
Kidney | Allogeneic, BM-MSCs | Two doses: First dose of 5 × 106 cells/kg during Tx, Second dose of 2 × 106 cells/kg 30 days after Tx | Cytoxan, Methylprednisolone (MEP), Low dose of TAC, MMF | 1st dose: renal allograft artery, 2nd dose: I.V. | 12 | Pilot study | Completed [64] |
Kidney | Allogeneic, BM-MSCs | Two doses: First dose of 5 × 106 cells/kg during Tx, second dose of 2 × 106 cells/kg 30 days after Tx | Cytoxan, MEP, Low dose of TAC, MMF | 1st dose: renal allograft artery, 2nd dose: I.V. | 32 | Pilot study | Completed [68] |
Kidney | Adipose-MSCs and BM-HSCs | 0.03 × 106 MSCs/kg + 8–10 × 108 HSCs per kg 5 days before Tx | ATG, Total lymphocyte irradiation, TAC, MEP | Portal infusion | 285 | 2 | [70] |