Effectiveness of Secretome from Human Umbilical Cord Mesenchymal Stem Cells in Gel (10% SM-hUCMSC Gel) for Chronic Wounds (Diabetic and Trophic Ulcer) – Phase 2 Clinical Trial

Figures & data

Table 1 Demographic Characteristics of Research Respondents

Parametric	Statistical Results
	Diabetes	Leprosy	All
	Mean (SD) Med (Min-Max) N (%)	Mean (SD) Med (Min-Max) N (%)	Mean (SD) Med (Min-Max) N (%)
Age	61.4 (10.83)	56.22 (9.01)	57.03 (9.32)
	58 (53–80)	55 (35–74)	55 (35–80)
Sex
Female	2 (40%)	12 (44.4%)	14 (43.8%)
Male	3 (60%)	15 (55.6%)	18 (56.3%)
Pus
No	2 (40%)	3 (11.1%)	5 (15.6%)
Yes	3 (60%)	24 (88.9%)	27 (84.4%)
Erythema
No	1 (20%)	10 (37.0%)	11 (34.4%)
Yes	4 (80%)	17 (63.0%)	21 (65.6%)
Erosion
No	-	1 (3.7%)	1 (3.1%)
Yes	5 (100%)	26 (96.3%)	31 (96.9%)
Edema
No	1 (20%)	27 (100%)	28 (87.5%)
Yes	4 (80%)	-	4 (12.5%)
Crusts
No	2 (40%)	9 (33.3%)	11 (34.4%)
Yes	3 (60%)	18 (66.7%)	21 (65.6%)
Granulation
No	2 (40%)	1 (3.7%)	3 (9.4%)
Yes	3 (60%)	26 (96.3%)	29 (90.6%)
Pus
No	2 (40%)	3 (11.1%)	5 (15.6%)
Yes	3 (60%)	24 (88.9%)	27 (84.4%)
Hyperpigmentation
No	1 (20%)	17 (63.0%)	18 (56.3%)
Yes	4 (80%)	10 (37.0%)	14 (43.8%)
Moist
No	-	-	-
Yes	5 (100%)	27 (100%)	32 (100%)
Daily Drugs
No	3 (60%)	5 (18.5%)	8 (25.0%)
Yes	2 (40%)	22 (81.5%)	24 (75.0%)
Comorbid
No	3 (60%)	15 (55.6%)	18 (56.3%)
Yes	2 (40%)	12 (44.4%)	14 (43.8%)
Pain
No	-	27 (100%)	27 (84.4%)
Yes	5 (100%)	-	5 (15.6%)
Weight	60.8 (6.76)	59.37 (6.91)	59.59 (6.80)
	58 (54–69)	60 (50–75)	59 (50–75)
Height	166.4 (6.23)	160.41 (8.75)	161.34 (8.60)
	165 (!59 – 175)	160 (140–175)	161.5 (140–175)
Systolic Blood Pressure	139.8 (19.14)	134.78 (20.52)	135.56 (20.09)
	131 (118–160)	131 (98–184)	131 (98–184)
Diastolic Blood Pressure	82 (13.84)	73.81 (10.34)	75.09 (11.11)
	83 (66–100)	74 (48–95)	75 (48–100)
Heart Rate	79 (4.06)	78.89 (6.83)	79.91 (6.42)
	79 (75–84)	77 (68–90)	78 (68–90)
Random Blood Sugar	89.4 (5.50)	133.70 (39.46)	126.78 (39.71)
	89 (83–98)	125 (72–232)	116 (72–232)
Number of Wounds
1 Wound	5 (100%)	22 (81.48%)	27 (84.4%)
2 Wound	-	2 (7.41%)	2 (6.25%)
3 Wound	-	2 (7.41%)	2 (6.25%)
4 Wound	-	1 (3.7%)	1 (3.1%)

Table 2 Wound Size Characteristics

Parametric		Baseline	Follow Up 1	Follow Up 2
		Mean (SD) Med (Min-Max)	Mean (SD) Med (Min-Max)	Mean (SD) Med (Min-Max)
Chronic Wound Due To DM (Jakarta)	Width (in cm)	3.02 (2.20)	3.02 (2.20)	2.64 (2.11)
		2.1 (0.5–6.0)	2.1 (0.5–6.0)	2 (0.5–6.0)
Number of Wound = 5	Length (in cm)	5.8 (4.22)	5.48 (4.36)	4.32 (4.31)
		5 (2.5–13.0)	3.5 (2.5–13.0)	2.5 (1.8–12.0)
	Area (in cm)	23.71 (31.39)	22.35 (31.60)	17.97 (30.32)
		11.55 (1.5–78)	11.55 (1.45–78)	6.0 (1.15–72)
Chronic Wound Due To Leprosy (Sitanala)	Width (in cm)	1.66 (1.15)	1.23 (1.03)	0.99 (0.88)
		1.15 (0.5–5.0)	1.0 (0–4.7)	0.7 (0–3.4)
Number of Wound = 36	Length (in cm)	1.94 (1.39)	1.5 (1.29)	1.28 (1.28)
		1.15 (0.5–5.0)	1.0 (0–4.7)	0.9 (0–5.0)
	Area (in cm)	4.32 (5.59)	2.75 (3.62)	2.06 (2.96)
		1.28 (0.25–25.0)	1.0 (0–13.16)	0.5 (0–10.5)
All of the Chronic Wounds (Jakarta)	Width (in cm)	1.83 (1.36)	1.44 (1.33)	1.19 (1.19)
		1.3 (0.5–6.0)	1.0 (0–6.0)	0.8 (0–6.0)
Number of Wound = 41	Length (in cm)	2.41 (2.26)	1.99 (2.25)	1.65 (2.08)
		1.60 (0.50–13.0)	1.2 (0–13)	1 (0–12)
	Area (in cm)	6.69 (12.93)	5.14 (12.39)	4.00 (11.29)
		2.21 (0.25–78)	1.2 (0–78)	1 (0–72)

Table 3 Changes in Chronic Wound Length, Width, and Area from the Beginning. The First Week and the Second Week

Time	Mean (SD)	Med (Min-Max)	p-value
Changes in Wound Area on All Chronic Wounds
Baseline	6.69 (12.93)	2.21 (0.25–78)	< 0.001		< 0.001
Follow Up 1	5.14 (12.39)	1.2 (0–78)		< 0.001
Follow Up 2	4.00 (11.29)	1 (0–72)
Changes in Wound Width on All Chronic Wounds
Baseline	1.83 (1.36)	1.3 (0.5–6.0)	< 0.001		< 0.001
Follow Up 1	1.44 (1.33)	1.0 (0–6.0)		< 0.001
Follow Up 2	1.19 (1.19)	0.8 (0–6.0)
Changes in Wound Length on All Chronic Wounds
Baseline	2.41 (2.26)	1.60 (0.50–13.0)	< 0.001		< 0.001
Follow Up 1	1.99 (2.25)	1.2 (0–13)		< 0.001
Follow Up 2	1.65 (2.08)	1 (0–12)

Note: Black box in the table above indicates exclusion from comparative statistical analysis.

Figure 1 Wound length from the beginning, first week, and second week for all chronic wounds.

Figure 2 Wound width from the beginning, first week, and second week for all chronic wounds.

Figure 3 Area changes for all chronic wounds beginning, first week, and second week.

Figure 4 Example of diabetic ulcer repair – before (left) and after intervention (right).

Figure 5 Mechanisms of angiogenesis and vasculogenesis in chronic ulcer treatment.⁴⁸

Figure 6 Schematic of secretome from stem cell derivatives in inducing wound healing.⁴⁹

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