治療效果論文
2型糖尿病
Clinical trial with control: stem cell therapy outcome related variables.
| Ref | 診斷病例數 – 年齡（第二型糖尿病病程） | Follow up | 來源 - 皮下注射類型 - 注射次數、劑量、途徑、重複注射次數、間隔 | Other T2DM Related Therapy | T2DM Related Outcome |
|---|---|---|---|---|---|
| 20 | T2DM1 56 (T), 62 (C) 18-60 y (T=8.6 ± 6.5, C=7.3 ± 6.3) |
1-2-3 mo, every 3 mo until -36 mo | T：自體骨髓單核細胞劑量？ DPA，1倍 C: ( – ) |
T: D, E, PST, BGM-MA C: D, E, PST, IIT, BGM-MA |
治療組的 HbA1c 和 C 肽水準明顯優於治療前水準或對照組。 治療中： 56 名患者中有 18 名停止使用胰島素； 19/56例胰島素減量>50%，10/56例胰島素減量15-50%，9/56例無反應者 對照組：40/62 名患者胰島素需求量增加 50% 以上，22/62 名患者胰島素需求量增加 15-45%。 |
| 21 | 2型糖尿病 20 (MNC-HBO), 20 (MNC), 20 (C1=HBO), 20 (C2) 40-65歲（2-15年） |
3-6-9-12 mo | 汽車 BM-MNC T1：MNC-HBO= 3641.2 ± 1585.4 M T2：MNC = 4012.5 ± 1431.9M DPA – 10 分鐘 1 次 |
T and C: D, L, PST, SBGM- IA | T1 和 T2、C1、C2 組 12 個月時胰島素劑量減少情況不變 無胰島素：T1：1/20，T2：2/20 12 個月時 AUC C-Pep 改善 T1= T2 > C1，AUC Ins 改善 T1 和 T2。 3、6、9 和 12 個月時，T1 和 T2 組的 HbA1c 均顯著降低，而 C1 和 C2 組的 HbA1c 則保持穩定。 6、9 和 12 個月時的空腹血糖 (FBG) 水準在 T1 和 T2 組中降低；3、6、9 和 12 個月時的空腹 C 肽水準在 T1 和 T2 組中顯著升高，但在 C1 和 C2 組中保持穩定。 |
| 22 | 2型糖尿病 11（T），10（C） T = 46.5–56 年（10–15.5 年） C = 52.5–56 年（16–21 年） |
2-4-6-8-10- 12wk-4-5-6- 9-12 mo | T: auto BM- MNC – 290M (220 -380M) C：假手術，生理食鹽水 SP/DA -1次，12週後： PB- GCSF- 白血球分離術 MNC – 490 (290–730M) C：假手術，生理食鹽水 – 靜脈注射 – 1 次 |
T 和 C：D、L、E、W-SBGM – IA | 12 mo: 50% Insulin reduction -Tr: 9/11 = 82%, -C:0/10, p= 0.002 Insulin red Tr > C (p=0.001, 6 mo), (p=0.004, 12 mo) HbA1C maintenance ( < 7%): Tr 10/11 (91%), C 6/10 (60%), p=0 .167 |
| 23 | T2DM 10 (MSC), 10 (MNC), 10 (C) MSC= 36-58 (8-23) MNC= 39.5-50 (8.5-15) C= 43-59 (9-15) |
2-4-8-12- wk-6-9-12 mo | AutoBM-MSC-P4-5 – 1M/kg 體重 自體骨髓單核細胞 – 1B/病患 C= 維生素B族 SPDA – 1x |
T and C: L, PST,D-SBGM- IA | 6/10 (MSC), 6/10 (MNC), 0/10 (C) achieved primary end point: 50% insulin requirement reduction, while maintaining HbA1c
< 7.0% ->significant difference |
| 24 | T2DM 31 (T), 30(C) 18-60 y (T=8.93±5.67 C=8.3±6.07) |
36 mo | T：沃頓膠 MSC P4 1M/kg 體重 C：生理食鹽水 IV – 2x（間隔 4 週） |
T and C: D, E, PST, SBGM- MA | 與對照組相比，血糖、HbA1c、C肽、胰島細胞功能穩態模型評估均顯著改善。 糖尿病併發症發生率：Tr組 – 與基線相比無增加，C組：4/30例新發糖尿病視網膜病變，3/30例新發糖尿病神經病變，3/30例新發糖尿病腎病變 –> 統計學顯著差異（Tr組與C組比較，P= 0.007） 減少胰島素劑量： 治療組：18/31 - 胰島素劑量減少 50%（其中 10/31 - WJMSC 術後 3-11 個月停止使用胰島素，停止使用胰島素的持續時間為 12.5±6.8 個月），5/31 - 減少 15-50%， 8月31日 無應答者 對照組：14/30：胰島素劑量增加 50% 以上，16/30：胰島素劑量增加 15%–45% – 30/30 – 無反應者 |
| 25 | T2DM + impotence2 7 (T), 3 (C) 57-87 (12-52 y, impo- tence minimal 6 months) |
2週至11個月 | T：UCB SC - His tostem、ABO、HLA-ABC、DR 和性別匹配 - 15M C：生理食鹽水注射 – CC -1x |
T and C:PST, D-SBGM-MA | Tr: Blood glucose levels decreased by 2 weeks, and medication dosages were reduced for 4 to 7 months (6/7). HbA1c levels improved after treatment for up to 3 to 4 months (7/7) Reduced insulin dose after 1 month (2/7) Control: no improvement in blood glucose level, HbA1c, and insulin dose. |
| 26 | T2DM 3 15 (T1), 15 (T2), 15 (T3), 3×5 C) T1= 57.7±8.2y (10.8± 7.3y ) T2= 55.3±11.4y (10.2± 5.7y) T3= 57.2 ±6.6y (9.6±4.5y) C= 58.7 ±7.3y (9.8±6.7y) |
12 wk 2y post study |
MPC-P(?)Rexleme-strocel-L – mesoblas Inc，冷凍解凍 T1=0.3 M/kg，T2=1 M/kg，T3=2 M/kg，C=安慰劑，靜脈注射，45分鐘，1次。 |
T and C: L, PST, BGM-RT | Tr：第 1 週後所有時間點的 HbA1c 降低；C：HbA1c 略有升高 臨床目標糖化血紅素 < 7% was achieved by 0/15 of Control, 2/15 of T1, 1/15 of T2, and 5/15 of T3 (P < 0.05) |
| 27 | T2DM4 13 (T), 13 (C) 10-58 歲 (0.5 – 11 歲) |
1y | 胎肝造血幹細胞 – 35-55 M (20% CD34) – 冷凍解凍 生理食鹽水（C）靜脈注射 – 1 次 |
T and C: BGM-FU | 在長達 1 年的時間裡，與對照組相比，空腹血糖和 C 肽並沒有明顯改善。 僅在第 6 個月時 HbA1c 有改善：治療組為 7.9±1.3，對照組為 7.0±0.86（p=0.046）。 所有治療方案均無需使用胰島素。 |
Ref=參考編號，T2DM=2型糖尿病，治療對照：1例患者選擇，2個連續組：2個治療組-1個對照組，其他：隨機，3個單盲多中心（18個-美國），4=2型糖尿病和第1型糖尿病，T=治療組，C=對照組，y=年，MNC=單核細胞，HBO=k週核細胞，HBO=mo，
SC= stem cell, Auto= autologous, BM= bone marrow, ?= data not available, DPA= dorsal pancreatic artery/substitute, M= million, SP/DA= superior pancreatic or duodenal artery, PB= peripheral blood, GCSF= granulocyte colony stimulating factor, IV- intra venous, P= passage, BW= body weight, B= billion, vit.= vitamin, SPDA= superior pancreaticoduode- nal artery, UCB= umbilical cord blood, CC= corpora cavernosa (penile root clamped with a band 30 min), MPC= mesenchymal progenitor cell, cryo= cryopreserved, hu= human, HSC= haematopoeitic stem cell, cryo= cryopreserved,D= diet, E= exercise, PST= previous standard therapy, BGM = blood glucose monitoring, MA= medication adjustment, IIT= insulin intensification therapy, L= lifestyle, SGBM= self blood glucose monitoring, IA= insulin adjustment, W-SGBM= weekly SGBM, D-SGBM= daily SGBM (minimum 5 points/week), RT= rescue therapy using oral anti diabetic agent, except thiazolidinediones in case there was unacceptable hyperglycemia, FU= at follow up
Current Stem Cell Research & Therapy, 2018(13)
Towards Standardized Stem Cell Therapy in Type 2 Diabetes Mellitus: A Systematic Review
Jeanne Adiwinata Pawitan, Zheng Yang, Ying Nan Wu and Eng Hin Lee
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